clinical research monitoring plan

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Monitoring of clinical trials

Current section refers to the item 5.18 Monitoring of the INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2). It contains the E6(R2) Addenda, and provides an overview of the scope of, requirements to clinical trial monitoring process, as well as responsibilities of all participants.

5 .18.1 Purpose

The purposes of trial monitoring are to verify that:

(a) The rights and well-being of human subjects are protected.

(b) The reported trial data are accurate, complete, and verifiable from source documents.

(c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).

5.18.2 Selection and Qualifications of Monitors

(a) Monitors should be appointed by the sponsor.

(b) Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. A monitor’s qualifications should be documented.

(c) Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s).

5.18.3 Extent and Nature of Monitoring The sponsor should ensure that the trials are adequately monitored. The sponsor should determine the appropriate extent and nature of monitoring. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial. In general there is a need for on-site monitoring, before, during, and after the trial; however in exceptional circumstances the sponsor may determine that central monitoring in conjunction with procedures such as investigators’ training and meetings, and extensive written guidance can assure appropriate conduct of the trial in accordance with GCP. Statistically controlled sampling may be an acceptable method for selecting the data to be verified.

The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The flexibility in the extent and nature of monitoring described in this section is intended to permit varied approaches that improve the effectiveness and efficiency of monitoring. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

On-site monitoring is performed at the sites at which the clinical trial is being conducted. Centralized monitoring is a remote evaluation of accumulating data, performed in a timely manner, supported by appropriately qualified and trained persons (e.g., data managers, biostatisticians).

Centralized monitoring processes provide additional monitoring capabilities that can complement and reduce the extent and/or frequency of on-site monitoring and help distinguish between reliable data and potentially unreliable data.

Review, that may include statistical analyses, of accumulating data from centralized monitoring can be used to:

identify missing data, inconsistent data, data outliers, unexpected lack of variability and protocol deviations.
examine data trends such as the range, consistency, and variability of data within and across sites.
evaluate for systematic or significant errors in data collection and reporting at a site or across sites; or potential data manipulation or data integrity problems.
analyze site characteristics and performance metrics.
select sites and/or processes for targeted on-site monitoring.

5.18.4 Monitor's Responsibilities.

The monitor(s) in accordance with the sponsor’s requirements should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site:

Acting as the main line of communication between the sponsor and the investigator.
Verifying that the investigator has adequate qualifications and resources (see 4.1, 4.2, 5.6) and remain adequate throughout the trial period, that facilities, including laboratories, equipment, and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period.
That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial.
That the investigational product(s) are supplied only to subjects who are eligible to receive it and at the protocol specified dose(s).
That subjects are provided with necessary instruction on properly using, handling, storing, and returning the investigational product(s).
That the receipt, use, and return of the investigational product(s) at the trial sites are controlled and documented adequately.
That the disposition of unused investigational product(s) at the trial sites complies with applicable regulatory requirement(s) and is in accordance with the sponsor.
Verifying that the investigator follows the approved protocol and all approved amendment(s), if any.
Verifying that written informed consent was obtained before each subject's participation in the trial.
Ensuring that the investigator receives the current Investigator's Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement(s).
Ensuring that the investigator and the investigator's trial staff are adequately informed about the trial.
Verifying that the investigator and the investigator's trial staff are performing the specified trial functions, in accordance with the protocol and any other written agreement between the sponsor and the investigator/institution, and have not delegated these functions to unauthorized individuals.
Verifying that the investigator is enroling only eligible subjects.
Reporting the subject recruitment rate.
Verifying that source documents and other trial records are accurate, complete, kept up-to-date and maintained.
Verifying that the investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial.
The data required by the protocol are reported accurately on the CRFs and are consistent with the source documents.
Any dose and/or therapy modifications are well documented for each of the trial subjects.
Adverse events, concomitant medications and intercurrent illnesses are reported in accordance with the protocol on the CRFs.
Visits that the subjects fail to make, tests that are not conducted, and examinations that are not performed are clearly reported as such on the CRFs.
All withdrawals and dropouts of enrolled subjects from the trial are reported and explained on the CRFs.
Informing the investigator of any CRF entry error, omission, or illegibility. The monitor should ensure that appropriate corrections, additions, or deletions are made, dated, explained (if necessary), and initialled by the investigator or by a member of the investigator's trial staff who is authorized to initial CRF changes for the investigator. This authorization should be documented.
Determining whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s).
Determining whether the investigator is maintaining the essential documents (see 8. Essential Documents for the Conduct of a Clinical Trial).
Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.

5.18.5 Monitoring Procedures

The monitor(s) should follow the sponsor’s established written SOPs as well as those procedures that are specified by the sponsor for monitoring a specific trial.

5.18.6 Monitoring Report

The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication.
Reports should include the date, site, name of the monitor, and name of the investigator or other individual(s) contacted.
Reports should include a summary of what the monitor reviewed and the monitor's statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and/or actions recommended to secure compliance.
The review and follow-up of the monitoring report with the sponsor should be documented by the sponsor’s designated representative.
Reports of on-site and/or centralized monitoring should be provided to the sponsor (including appropriate management and staff responsible for trial and site oversight) in a timely manner for review and follow up. Results of monitoring activities should be documented in sufficient detail to allow verification of compliance with the monitoring plan. Reporting of centralized monitoring activities should be regular and may be independent from site visits.

5.18.7 Monitoring Plan

The sponsor should develop a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial. The plan should describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods to be used, and the rationale for their use. The plan should also emphasize the monitoring of critical data and processes. Particular attention should be given to those aspects that are not routine clinical practice and that require additional training. The monitoring plan should reference the applicable policies and procedures.

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Monitoring Plan Template

This ready-to-use template is for setting up a monitoring plan. It is up to date with Swiss and international laws and recommendations and allows clinical research professionals to plan the extent of monitoring by using a risk-based strategy. This template is particularly useful for multicentre trials within the SCTO’s CTU Network but is suitable for all sites conducting clinical research.

More quality and consistency in the monitoring of multicentre studies in an academic setting

The up-to-date and user-friendly Monitoring Plan Template can be used to set up a monitoring plan.

This template helps sponsors to create a monitoring plan according to the guidelines for Risk-Based Monitoring, including defining the extent and strategy of monitoring, visit scheduling, and monitoring activities as well as clarifying the monitor’s, sponsor’s, and investigator’s responsibilities. It is part of a series of monitoring templates that includes:

Monitoring Site Initiation Visit (SIV) Report Template
Monitoring Visit Report Template
Monitoring Close-Out Visit (COV) Report Template

This template is suitable for any monitor and sponsor engaged in clinical research in Switzerland and abroad. We particularly recommend using this template within the SCTO’s CTU Network for investigator-initiated, multicentre studies.

This template was developed by the SCTO’s Monitoring Platform and first published in June 2020 and last updated in February 2022 (V2.0).

The numerous monitoring responsibilities that exist can be found in ICH GCP and ISO 14155. Compliance with the protocol is important in order to ensure ethical conduct of clinical trials, scientific validity, and the accuracy and completeness of data produced during a clinical study. Monitoring helps to ensure this compliance. With this template, we aim to improve the quality and consistency of the monitoring of investigator-initiated, multicentre studies within the SCTO’s CTU Network.

This template is licensed under CC BY-NC 4.0. The content can be shared and adapted as long as you follow the license terms. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc/4.0/ .

Monitoring Plan Template V2.0 (last revised in January 2024) (docx, 1.3 MB)

Our templates and tools are free. As a publicly funded organisation, we strive to inform the public about the impact of our work and to continually improve our services. We therefore kindly ask you to leave us your email address so we can contact you with a short one-time survey. You may download the document without providing your personal data.

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Easy Guide to Clinical Studies (Easy GCS)

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Risk-Based Monitoring (RBM) Score Calculator

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Safety reporting forms for clinical research projects

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Monitoring Planning

Monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.  The clinical research monitor is the person with direct access to, and oversight of the site research activities. They conduct monitoring visits in accordance with a monitoring plan and provide feedback and training to sites as necessary.   

Regular site monitor visits can be broken down into four types: pre-study visits, initiation visits, periodic monitoring visits, and close-out visits. Study sites may also be monitored or audited by the FDA, Clinical Research Organizations (CROs), IRBs and sponsors.

Before the study begins the monitor may come out for some pre study visits, or those may be conducted remotely. A site initiation visit will be conducted, in person or remotely, to formally document that a site is ready to begin engaging in the conduct of the trial.

At the start of the study the monitor should be identified, the site should be qualified by the OCR Regulatory Services team. For industry sponsored trial, a monitor will be provided. For IITs it would be necessary to identify a monitor for the study.

The monitor is typically part of the Site Initiation Visit (SiV), led by the Regulatory Sponsor for the study. The monitor will then conduct ongoing monitoring, according to the data safety monitoring plan, throughout the trial.

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Clinical Research Study Investigator’s Toolbox

Supporting Clinical Research

The purpose of the NIA Clinical Research Toolbox is to provide a Web-based informational repository for investigators and staff involved in clinical research. The Toolbox contains templates, sample forms, guidelines, regulations and informational materials to assist investigators in the development and conduct of high quality clinical research studies.

Study Startup

Recruitment and retention resources.

NIA Guidance on Clinical Trials

Forms and Templates

Glossary of Terms

Note: NIA is refreshing the entirety of the NIA Clinical Research Toolbox. Check back for updates.

Data Safety and Monitoring

As depicted in the NIA Guidance on Clinical Trials , NIA is responsible for overseeing the data and safety monitoring of the clinical research it supports. Data and safety monitoring of a clinical trial is commensurate with the risks posed to the study participants and with the size and complexity of the study.

Applicants requesting support for any intervention study must complete "PHS Human Subjects and Clinical Trials Information" form of the SF424 (R&R), describe a data and safety monitoring plan (DSMP), which discusses the need for an independent data and safety monitoring body or justifies why such a body is not needed to monitor the study and proposes an alternative safety monitoring mechanism. For example, for a single-site, low risk study, the PI may propose a local safety monitor, while a multi-site, higher risk study might propose a Data and Safety Monitoring Board (DSMB).

For behavioral and social clinical trials, consider using the adapted DSMP Template (MS Word, 62K) .
Guideline for Budgeting for Data and Safety Monitoring Activities (MS Word, 25K) aids investigators in budgeting for an independent DSMB or a Safety Officer when preparing the budget section of a grant application.

Data Sharing

The National Institutes of Health (NIH) advocates making available to the public the results and accomplishments of the activities that it funds. NIH assures that research resources developed with public funds become readily available to the broader research community in a timely manner for further research, development, application, and secondary data analysis. The expectation is that this will lead to products and knowledge of benefit to public health. To ensure that future research can build on previous efforts and discoveries, the National Institutes of Health (NIH) has developed a data sharing policy effective October 1, 2003, for applicants seeking NIH funding of $500,000 or more in direct costs in any one year. The policy expects final research data, especially unique data, from NIH-supported research efforts be made available to the investigators. The NIH policy on data sharing applies to:

Basic research, clinical studies, surveys, and other types of research supported by the NIH.
Human subjects and laboratory research.
Data not produced with NIH funding but used in an NIH-supported activity in some instances.

Investigators are expected to include in their grant application a brief description of how final research data will be shared, or explain why data-sharing is not possible (for example: human subject protection concerns). Please see NIH’s Example Plan (MS Word, 55K) for a template you may modify to fit the data you plan to share.

Initial Proposal Concept Form (MS Word, 39K) - This form should be used to advocate for an initiative by the Division of Geriatrics and Clinical Gerontology (DGCG) for a clinical trial or trials that exceed $2 million in direct costs in any year of funding. DGCG Clinical Trials Advisory Panel, a task force of the National Advisory Council on Aging (NACA), will evaluate the concept proposals in October – November of each Fiscal Year and will provide its recommendations to DGCG, NACA, and to the NIA Director on initiatives for large clinical trials.

The clinical protocol is a document that describes how a clinical study will be conducted by detailing the objective(s), design, methodology, statistical considerations and organization of a clinical study, and describes methods used to ensure the safety of the study participants and integrity of the data collected.

Protocol (MS Word, 93K) - The Clinical Intervention Study Protocol Template outlines a clinical study protocol and provides guidance on important content to include in each section. The template can be downloaded as an MS Word file for adaptation by the study investigator.

Manual of Procedures

A Manual of Procedures (MOP) is a handbook that details a study’s conduct and operations as well as facilitates consistency in protocol implementation and data collection across study participants and sites. It operationalizes the study protocol and describes each step of the study and how it is to be executed. A copy of the MOP should be provided to each member of the Study Team. Ideally, the MOP would contain an adequate amount of detail that any individual(s) at any site(s) could run the study consistently with only the information contained in the MOP and its appendices.

The NIA recognizes the importance of a MOP and has developed documents to assist principal investigators in writing their study MOP. Investigators with a multi-site study are required to submit a MOP, while single-site study investigators are strongly encouraged to review the MOP and determine which sections are necessary in order to ensure the study procedures are performed as intended. The Guidelines below provide details on each section of the MOP, while the MOP Outlines are an overview listing the sections that are most relevant in those types of studies.

Manual of Procedures (MOP) Outline – Multi-Site (MS Word, 30K)
Manual of Procedures (MOP) Guidelines – Multi-Site (MS Word, 2.9M)
Manual of Procedures (MOP) Outline – Single-Site (MS Word, 27K)
Manual of Procedures (MOP) Guidelines - Single-Site (MS Word, 170K)

The following documents can also be found within the MOP template:

Schedule of Events presents the activities that take place at each contact with the participant.
Protocol Deviation Log provides participant-specific documentation of missed visits and other actions that deviate from the protocol.

Informed Consent

The consent process provides individuals with sufficient information for making informed decisions about participation in a clinical research study. The following documents are provided as a tool to assist NIA investigators for developing a comprehensive informed consent:

Informed Consent Checklist (MS Word, 54K) presents required and additional elements of the consent forms as set forth in Code of Federal Regulations.
Informed Consent Version Tracker (MS Excel, 20K) provides a template with two examples of tools that sites may use to track informed consent versions; this helps minimize the use of expired versions and the occurrence of consent deviations.
Informed Consent for Secondary Research with Data and Specimens (PDF, 736K) , from NIH's Office of Science Policy, provides points to consider and sample language for informed consent documents for research studies that plan to store and share data and/or biospecimens for future use.

Data Safety and Monitoring Boards

The Data and Safety Monitoring Board (DSMB) is an independent group of experts that advises the NIA Director and the study investigators. The members of the DSMB serve in an individual capacity and provide their expertise and recommendations. The need for DSMB oversight is based on assessment of the study’s overall risk. Investigators may propose a DSMB in their grant application, or NIA may require that a DSMB be established following consideration of review panel’s comments, NIA’s National Advisory Council on Aging (NACA) advice, and/or input from NIA staff.

Sample Data and Safety Monitoring Board Charter (MS Word, 25.8K) The DSMB Charter describes the responsibilities of the DSMB to ensure ongoing, independent study review and assure the study is conducted according to the highest scientific and ethical standards.
DSMB Conflict of Interest and Confidentiality Statement (MS Word, 22K) and DSMB Conflict of Interest and Confidentiality Statement (PDF, 130K) - All members of the DSMB are required to be independent of the studies being reviewed and need to certify this by signing a DSMB Conflict of Interest and Confidentiality statement.
DSMB Report - Single Site Open (MS Word, 323K)
DSMB Report - Single Site Closed (MS Word, 342K)
DSMB Report - Multi Site Open (MS Word, 449K)
DSMB Report - Multi Site Closed (MS Word, 348K)

Additional Startup Tools

Data Management Tips (MS Word, 30K) help to ensure adequate data management processes and procedures in a clinical study. Investigators are encouraged to use Data Management Tips to describe how data will be handled in the study.
Best Practices for Data Coordinating Centers – This Compendium, developed by the National Heart Lung and Blood Institute (NHLBI) provides helpful tips for clinical researchers and other stakeholders for developing large, multisite clinical trial programs.

The NIA Clinical Research Toolbox includes a broad array of resources to support communications, training, recruitment, engagement and more. Learn about research and retention resources below.

Communicating with Participants, Staff, and Community Partners

A collection of outreach, recruitment, and engagement resources providing tips and strategies for communicating with potential clinical trial participants.

ADORE (Alzheimer’s & Dementia Outreach, Recruitment & Engagement Resources) An NIA repository of resources to support the recruitment and retention of participants into clinical trials and studies on Alzheimer’s disease and related dementias. 

Alzheimer’s and Dementia Information to share with Participants NIA resources for caregivers and people living with dementia.

Engagement and Access for Research-Active Institutions (EARA) Resource from the Office of the Director is a communication tool focused on outreach to research-active institutions and NIH institutes, centers, and offices.

Guidance regarding social media tools Developed by the NIH Office of Intramural Research and provides best practices when using social media tools and new technologies to recruit for clinical trials.

Person-first and Destigmatizing Language   From the NIH Style Guide, this resource offers guidance on the principles for inclusive communication and defines person-first language and identity-first language. 

Providing Care to a Diverse Older Adult Population An NIH resource on communicating with a diverse older patient population with tips for culturally sensitive care.

Recruiting and Communicating with Participants     NCCIH presents strategies about how to be thoughtful about participants, staff, and community partners with emphasis on good communication skills and habits.  

Talking to Your Patient About a Clinical Trial    NIH provides communication guidance in the form of a modified checklist for talking to patients about clinical trials. 

Talking With Older Patients NIH shares tips for communicating with older patients, including families and caregivers as part of the health care team, obtaining a thorough history from participants, discussing medical conditions and treatments, confusion and cognitive problems, and sensitive topics.

Diversity Among Staff

A set of resources related to developing and training a diverse clinical research workforce.

Chief Officer for Scientific Workforce Diversity (COSWD) An NIH resource dedicated to the diversity of the scientific workforce and use of evidence-based approaches to catalyze cultures of inclusive excellence.

Building a Diverse Scientific Workforce A NIDCD resource focused on enhancing the diversity of the biomedical, behavioral, and clinical research workforce.

Scientific Workforce Diversity Programs at NIA An NIA resource with opportunities for career development and training for researchers.

Scientific Workforce Diversity Seminar Series: How Do Research-Active Institutions (e.g. HBCUs, TCUs, and MSIs) Impact the Diversity of the Scientific Workforce? This seminar, hosted by the NIH Chief Officer for Scientific Workforce Diversity (COSWD), featured a panel sharing data and perspectives on the critical role of Research-Active Institutions (RAIs) in enhancing the diversity of the scientific workforce. Panelists also discussed how NIH and other funders might better partner with and support these institutions in enhancing their impact.

Engagement and Recruitment Planning Resources

Resources related to clinical trials planning, recruitment, and engagement.

AD/ADRD Clinical Studies Recruitment Planning Guide   A resource developed by the NIA that outlines strategies for clinical research recruitment.

Accrual Stages   An NCCIH resource on the five stages of study development including: Developing a Study; Selecting & Preparing to Open a Study; Recruiting and Communicating with Participants; Implementing the Study; and Evaluating Accrual and Reporting Lessons Learned.

National Strategy for Recruitment and Participation in Alzheimer's and Related Dementias Clinical Research   Published by the NIH and NIA, the National Strategy is designed to engage broad segments of the public in Alzheimer’s and related dementias research. 

OutreachPro   NIA developed a free online recruitment materials generator for researchers and research teams to create customizable outreach materials. OutreachPro has a library of content designed specifically for African American, Hispanic/Latino, Asian American and Pacific Islander populations and available in English, Spanish, Simplified Chinese, Tagalog and Hindi. Explore the OutreachPro  video playlist for videos on clinical trial participants, caregivers, and the benefits of participating in clinical research. 

Recruiting & Communicating with Participants An NCCIH resource to engage intermediaries to aid in accrual to clinical research:

Recruitment & Retention A resource from the Diversity in Extramural Programs focused on recruitment planning.

Recruitment & Retention Planning: Getting Started   Resources and tips from NINDS to create a recruitment and retention plan while you are writing the grant proposal and study protocol.

Identify potentially eligible participants
Engage participants in the Informed Consent Process
Consider participant financial issues
Maintain the morale and interest of staff, participants and their families
Update participants regarding study related events and results

Inclusion and Disparities

A collection of recruitment and retention resources focused on health disparities and inclusion of underrepresented populations.

CEAL (Community Engagement Alliance)   CEAL is an NIH research network designed to work with communities and community-based organizations to identify promising engagement and outreach practices that communicate trustworthy, science-based information to communities experiencing health disparities.

Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products    This guidance provides FDA’s expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical studies.

Community Health Disparities Recruitment    From NHLBI, this Community Health Toolkit was designed to assist in planning, running, and evaluating programs and includes recruiting scenarios and informational handouts.

Cultural Competence    Resources from across NIH are presented for researchers to consider regarding importance of cultural competence to promote effective and culturally informed recruitment and retention strategies.

Enhancing the Diversity of Clinical Trial Populations This FDA guidance recommends approaches that sponsors of clinical trials can take to increase enrollment of underrepresented populations in their clinical trials.

Health Disparities Framework This NIA page is designed to serve as a resource for scientists interested in investigating health disparities related to aging. It lists the priorities in aging research.

Health Equity Guiding Principles for Inclusive Communication The CDC provides guidance for health communicators to ensure their communication products and strategies adapt to the specific cultural, linguistic, environmental, and historical situation of each population or audience of focus.

NIH Inclusion Policies for Research Involving Human Subjects   NIH is committed to supporting clinical research that benefits individuals of all sexes/genders, races, ethnicities, and ages. The information provided on this website is designed to assist the extramural community in addressing inclusion, including the Inclusion of Women and Minorities policy and the Inclusion Across the Lifespan policy, in NIH grant applications and progress reports. 

Primary Barriers and Facilitators to Participation in Clinical Research     The Office of Research on Women's Health at NIH provides a summary of the literature on the barriers and facilitators to recruiting from diverse backgrounds to clinical trials.

Recruitment and Retention From NIH, this website offers strategic considerations for outreach by population group and includes other recruitment resources. 

Recruitment and Retention of Women in Clinical Research NIH Inclusion Outreach Toolkit on how to engage, recruit, and retain women in clinical research with strategies that are relevant to women and translatable across many subgroups of the U.S. population. This toolkit also includes case studies that highlight effective recruitment practices. 

Information for Participants

A collection of resources to help individuals learn more about clinical research, and find available clinical trials by location, condition, and intervention.

NIA Clinical Trials and Studies   An NIA resource providing a variety of articles for potential clinical trial participants.

NIH Clinical Research Trials and You    An NIH resource for people who want to learn more about clinical trials. It includes commonly asked questions and responses about participating in a clinical trial.   

ClinicalTrials.gov    An online database of clinical research studies that provides information about clinical research studies to the public, researchers, and health care professionals.  Visit the Learn About Studies page to learn more.

Find Clinical Trials Tool for the public to find Alzheimer’s and related dementias clinical trials by location.

Personal Stories About Alzheimer’s and Related Dementias Research Watch English videos from clinical trials participants or Spanish videos from clinical trials participants .

ResearchMatch    An NIH funded nonprofit program that helps to connect people interested in research studies with researchers from top medical centers across the US. 

“Why I Participate” Videos     From the NIA YouTube channel, this playlist contains videos of caregivers and those who are at risk for Alzheimer’s disease.

General Resources

Plainlanguage.gov A resources design to help teams communicate in a way that their audience can understand the first time they read or hear it.

OutreachPro NIA developed a free online recruitment materials generator for researchers and research teams to create customizable outreach materials. OutreachPro has a library of content designed specifically for African American, Hispanic/Latino, Asian American and Pacific Islander populations and available in English, Spanish, Simplified Chinese, Tagalog, and Hindi. Explore the OutreachPro  video playlist for videos on clinical trial participants, caregivers, and the benefits of participating in clinical research. 

Recruitment Innovation Center (RIC) Advice, guidance and recommendations about community engagement, recruitment planning and feasibility assessment, recruitment materials, EHR-based cohort assessments, and expression of interest.

Community Informed Recruitment and Retention Template A tool to assist research teams in achieving recruitment and retention goals of historically underrepresented racial and ethnic populations.

Investigators must include in their application proposed adverse event (AE) and serious adverse event (SAE) definitions and discuss their monitoring and reporting. All clinical trials of drugs and biological products conducted under an Investigational New Drug Application (IND) must use definitions of adverse events and adverse reactions and follow the reporting requirements established by 21 Code of Federal Regulations (CFR) Part 312.32. Trials of medical devices conducted under an Investigational Device Exemption (IDE) must use the definitions and reporting requirements established by 21 CFR 812. All other interventional studies must propose their definitions of adverse events and their reporting procedures. See the NIA Guidance on Clinical Trials for additional information .

Adverse Event Form ( MS Word , 38K or screen-readable PDF , 69K) provides a template for a study form for collecting information about adverse events that is reviewed by safety monitoring bodies.
Serious Adverse Event Form ( MS Word , 31K or screen-readable PDF , 769K) provides a template for a study form for collecting information about serious adverse events. The form includes major components of the Food and Drug Administration (FDA) Form 3500.
AE/SAE Process Flow (PDF, 119K) illustrates how adverse events and serious adverse events are handled within a study.

The NIA Safety Training Course (available below), an online training venue, provides an overview of human subject safety surveillance and reporting requirements in clinical research studies. The intent of the course is to help clinical study investigators and staff understand and implement NIA and regulatory requirements for safe, high quality clinical research. The topics covered include Good Clinical Practice (GCP), Human Subject Protections, Adverse Events and Unanticipated Problems, Safety Monitoring and Reporting Requirements, Safety Monitoring and Oversight: Data and Safety Monitoring Boards (DSMBs) and Safety Officers, Regulatory Requirements and Responsibilities of Principal Investigators, and Data and Safety Monitoring Plans. The course requires about 40 minutes to complete.

Administrative Forms

Screening Log (MS Excel, 47K) Provides documentation of all individuals who were evaluated for participation in a research study. The log typically contains a unique identification number for each person screened along with individuals’ date of birth, gender, race and ethnicity, screening date, and eligibility status.

Site Signature Log - Delegation of Authority Log ( MS Excel, 47K or screen-readable PDF, 294K ) A record of all study personnel and their specific responsibilities, signatures, and dates of involvement during the conduct of a clinical research study.

Note to File Template (MS Word, 20K) – Used by clinical site staff to document protocol deviations or other discrepancies identified during the conduct of the clinical research study and plans for resolution/prevention.

Sample Visit Flow and Schedule (MS Word, 25K) – The visit schedule tracks an individual participant’s progress through the study and helps to ensure that visits take place during the protocol-specified timeframe. The visit flow provides an overview of the activities that take place at each study visit, and may be customized for each study site.

Study Drug/Investigational Product Tracker (MS Excel, 12K) – Used to track study drug/investigational product disposition and accountability by the clinical research site. For multi-site studies under an investigational new drug (IND) application, this tracker could be used by coordinating centers to track the overall distribution of investigational product.

Study Drug/Investigational Product Compliance Log (MS Word, 30K) – Used to track study drug/investigational product disposition and accountability for each individual participant. This form may be used to track protocol adherence via amount dispensed and returned and is designed to be used in conjunction with the Study Drug/Investigational Product Tracker. May also be used to track study drug/investigational return or destruction.

Study-wide Forms

Adverse Events Form ( MS Word, 38K or screen-readable PDF, 68K )

Prior and Concomitant Medications ( MS Word, 34K or screen-readable PDF, 58K )

Protocol Deviations Form ( MS Word, 46K or screen-readable PDF, 80K )

Serious Adverse Events Form ( MS Word, 31K or screen-readable PDF, 769K )

Study Disposition Form ( MS Word, 32K or screen-readable PDF, 56K )

Baseline Visit Forms

Visit Checklist ( MS Word, 34K or screen-readable PDF, 53K )

Eligibility Form ( MS Word, 29K or screen-readable PDF, 184K )

Demographics Form ( MS Word, 32K or screen-readable PDF, 661K )

Medical History Form ( MS Word, 50K or screen-readable PDF, 87K )

Medical History Conventional ( MS Word, 54K or screen-readable PDF,184 K )

Vital Signs Form ( MS Word, 33K or screen-readable PDF, 101K )

Physical Exam Form ( MS Word, 73K or screen-readable PDF, 193K )

Randomization and Enrollment Form ( MS Word, 32K or screen-readable PDF, 806K )

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Last updated: August 27, 2024

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Your clinical trial monitoring plan: 5 tips from a regulatory specialist.

Good Clinical Practices (GCP) requires that “essential documents” be filed at the sponsor and investigative sites in a timely manner. While the sponsor is responsible for establishing a Trial Master File (TMF), the site is responsible for the Investigator Site File (ISF), which many call the Regulatory Binder . A key part of creating a plan for a clinical trial monitoring visit is to ensure that the ISF is appropriately updated and maintained.

The ISF or Regulatory Binder contains a lot of study-specific sets of documents–sometimes over 150 documents in one study! 1 You may start the study with just one big binder, but by the time the study is over, you could have three big binders holding all of the documents that accumulated over time.

These Regulatory Binders stick around around for a long time. Regular monitoring visits continue until study close-out, even if your study has stopped enrolling, or all follow-up visits are completed. Some such studies may take a year or two before close-out, at which point you can finally store away those Regulatory Binders.

Having been on both sides of the aisle, here are my tips to plan for a positive clinical trial monitoring visit when it comes to the Regulatory Binders.

Tip #1: Long Before the Monitoring Visit, Keep your Delegation of Authority Log & Protocol Trainings Air-Tight

When prepping for a monitoring visit, always start with the delegation log . Have the DOA log in front of you and check to make sure each site member has a CV, a GCP certificate, an IATA certificate (if they process lab shipments), and relevant training certificates depending on their delegated duties. Check to ensure each person has appropriate protocol training – and training on all protocol amendments that have come out.

Keeping track of trainings is the most important and challenging task – especially if there’s turnover at your site and people are added or taken off the delegation log. I used to keep study-specific lists of trainings that would help me track which staff had which trainings outstanding so I could follow up with them. It’s a very tedious but important process.

Pro tip: Clinical Research IO just released the first-ever electronic delegation log in the industry. I guarantee this feature will keep you more organized with trainings and certifications. Read more about the electronic Delegation Log here !

Tip #2: Cross Off Your Site Monitor’s Action Items From the Last Monitoring Visit

Refer to the follow up letter from the previous monitoring visit and check off each action item as you complete it. In fact, you may want to keep a running log of each item and the corrective action taken, then have the PI sign off prior to each monitoring visit. Also, sometimes the monitor will flag action items in the form of sticky notes that do not make it to the follow up letter. Be sure to address those notes as well.

Tip #3: Store your regulatory binders in one neat place

Keep all your study documents together in one place. Sometimes, you may choose to keep a document housed outside the study regulatory binder (eg, CVs) – in that case, put a Note To File (NTF) in the study binder specifying where the document is kept. We once had a NTF specifying the location to be a former coordinator’s office that no longer existed! We eventually found this document but only after spending hours looking for it. It’s therefore wise to have an area dedicated to ISFs, instead of just keeping binders in the prime coordinator’s office . A small site may dedicate a single bookshelf, while a medium sized site could have all binders housed in a single office. It’s a very simple solution that may end up saving your site a lot of time.

Also ensure the Sponsor’s name and study ID are clearly visible on the spine. Preferably arrange them in an alphabetical/ chronological order. By following these organizational tips, you will quickly be able to pull out any document you need at a moment’s notice.

Tip #4: Digitize Your Common Documents in Your Regulatory Binders

Some documents are common across all studies – e.g., the site CLIA certification, calibration certificates for various equipment, temperature logs, etc. You may want to organize these separately from your study-specific binders, using the Note To File method described above. Especially for these documents, keep electronic copies at all times . I once had a close-out visit at which the monitor requested that I email her all the GCP certifications and temperature logs going back 3 years! If I did not have electronic copies of all these documents, one of us would have spent all of our time by the copier machine scanning an entire binder.

An easy way to do this is using eRegulatory software built specifically for research sites.

Tip #5: Track All of The Document Expiration Dates In Your Regulatory Binders

If your site works with multiple investigators, you obviously keep track of expiration dates of medical licenses. But you also have other documents to track as well – calibration certificates, GCP trainings, IATA trainings, DEA licenses, state-specific licenses, etc. Keep a master log of all these documents and their expiration dates.

Pro tip: You may want to put in a reminder in your calendar in advance of expiration so you know when to start working on renewal, or who you have to notify to get going. CRIO’s eRegulatory software automates this process.

My Concluding Thoughts on Your Clinical Trial Monitoring Plans

By now, you should have realized how much there is to organize and track when it comes to Regulatory documents! That’s why at CRIO, I’ve been honored to have the opportunity to assist in building the company’s eRegulatory module. With CRIO’s eREG module, sites can store, route, e-sign and download files electronically; create electronic delegation of duty logs; track required trainings; set expiration alerts; respond to CRA queries; and manage common documents across multiple studies.

In fact, CRIO’s eReg solution is built off of all the best practices I describe here. It’s what I wish I had when I was doing regulatory work , and although I can’t use it as a practitioner, I get immense pleasure thinking how much work it will save my colleagues.

Interested in CRIO’s eReg solution? See it in action !

1 For example: Investigator’s Brochure (IB), protocol and protocol amendments, FDA form 1572, Investigator and site staff CVs, delegation log, training certificates, professional licenses, financial disclosure forms, IRB documents, Informed Consent forms, Sponsor and IRB correspondence, the Enrollment Log, a drug/device accountability log, temperature logs, CLIA and other certificates, AE/SAE reports/logs, site monitoring log and letters.

21 CFR Part 11 Regulation Compliance Update

Compliance Update: The 21 CFR Part 11 Regulation is a cornerstone of conducting clinical trials in today’s world. The release of the regulation 1997 established guidelines for the use of electronic records and electronic signatures in FDA-regulated industries and had a significant impact on the pharmaceutical and medical device industries. The FDA began working on...

The Current State of Clinical Trials in Ukraine—A Conversation with Dr. Roman Fishchuk

Meet Dr. Roman Fishchuk, an esteemed otorhinolaryngologist (ENT) whose journey in the healthcare field has been marked by a commitment to providing medical care and innovative treatment options through clinical trials in his native Ukraine. Having graduated from Ivano-Frankivsk National Medical University, Dr. Fishchuk specialized in otolaryngology and completed a Master’s degree at the University...

Geting Ready for Data Migration with CRIO

Transitioning to CRIO? How to Get Your Data Ready for Migration

You have just signed on to use CRIO and you are excited to get started. Even if you are moving primarily from paper, you may have data that you want to migrate into CRIO rather than having to re-enter it. For many of our new clients, they have a wealth of information available in spreadsheets...

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Downloadable Templates and Tools for Clinical Research

Welcome to global health trials' tools and templates library. please note that this page has been updated for 2015 following a quality check and review of the templates, and many new ones have been added. please click on the orange text to download each template., the templates below have been shared by other groups, and are free to use and adapt for your researchstudies. please ensure that you read and adapt them carefully for your own setting, and that you reference global health trials and the global health network when you use them. to share your own templates and sops, or comment on these, please email [email protected]. we look forward to hearing from you.

These templates and tools are ordered by category, so please scroll down to find what you need.





































































































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To share your own templates and SOPs, or comment on these, please email [email protected]. We look forward to hearing from you!

Webinar on community engagement in clinical research involving pregnant women
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This is Degena Bahrey Tadesse from Tigray, Ethiopia. I am new for this web I am assistant professor in Adult Health Nursing Could you share me the sample/templet research proposal for Global Research Nurses Pump-priming Grants 2023: Research Project Award

I have learned lot..Thanks..

i was wondering why there is no SOP on laboratory procedures ?

Hi, Can you provide me the SOP for electronic signatures in Clinical trial

Do you have an "SOP for Telephonic site selection visit". Kindly Share on my registered mail ID

Thank you for sharing the resources. It is very kind of you.

Hi These tolls are very useful! Thank you

Do you have a task and responsability matrix template for clinical trial managment ? Best

I am very much happy to find myself here as a clinician

Dear Getrude

We have a free 14-module course on research ethics on our training centre; you'll receive a certificate if you complete all the modules and quizzes. You can take it in your own time. Just visit 'Training centre' in the tabs above, then 'short courses'.

Kind regards The Editorial Team

need modules on free online gcp course on research ethics

Estimados: me parece excelente el aporte que han hecho dado que aporta. por un lado a mejorar la transparencia del trabajo como a facilitar el seguimiento y supervisión de los mismos. Muchas gracias por ello

We also have an up to date list of global health events available here: https://globalhealthtrials.tghn.org/community/training-events/

Dear Nazish

Thank you, I am glad you found the seminars and the training courses useful. We list many training events (all relevant to Global Health, and as many of them as possible are either free or subsidised) on the 'community' web pages above. Keep an eye on those for events and activities which you can get involved with. Also, if you post an 'introduction' on the introduction group stating where you are from and your research interests, we can keep you updated of relevant local events.

Thanks so much. These are very helpful seminars. Please let me know any other websites/links that provide free or inexpensive lectures on clinical Research. Appreciate your help.

Hi Nazish, and welcome to the Network. The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? If so - no problem! You can find free seminars with sound and slides here: https://globalhealthtrainingcentre.tghn.org/webinars/ , and you can find free, certified eLearning courses here: https://globalhealthtrials.tghn.org/elearning . Certificates are awarded for the eLearning courses for those scoring over 80% in the quiz at the end of each course. If you need anything else, do ask! Kind regards The Editorial Team

Hi, I am new to this website and also to the Clinical Research Industry for that matter I only am able to see the PDF of these courses, just wanted to know are these audio lectures and also happen to have audio clips that go with the pdf?

This site is impeccable and very useful for my job!!!!

Thank you for your kind comments.

Fantastic resources

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Useful Resources

The Ultimate Guide to Clinical Research Monitoring

Clinical research monitoring plays a crucial role in the success of clinical trials, encompassing diverse activities to guarantee the safety and precision of collected data. The execution of clinical trials must adhere to regulatory standards, prioritize the protection of human study participants, and minimize potential health risks. Monitoring activities include auditing study sites, assessing data accuracy and completeness, protocol and amendment reviews, scrutiny of case report forms (CRFs), identification of deviations from standard operating procedures (SOPs) or protocols, management of corrective action plans (CAPs), safety report follow-ups, and tracking progress against enrollment goals.

For those interested in becoming involved in clinical trial management and oversight, the Advanced Clinical Research Project Manager Certification offers extensive training in these key areas.

Beyond data quality assessment, clinical research monitoring ensures compliance with regulatory standards such as GCP (Good Clinical Practices) , ICH (International Conference on Harmonization) , FDA regulations, and local laws. Those looking to deepen their understanding of these standards might find the ICH-GCP course particularly beneficial. Ongoing monitoring throughout a study, coupled with potential audits by sponsors or regulatory authorities, contributes to the accuracy, reliability, and applicability of clinical trial results for informed medical decisions.

Steps to Clinical Monitoring:

Craft a Robust Monitoring Strategy: Develop a thorough monitoring plan encompassing essential elements. This includes specifying the types of monitoring activities, setting the frequency of monitoring visits, outlining data collection methods, and establishing clear criteria for acceptable performance.

Aspiring Clinical Research Coordinators can enhance their strategy formulation skills through the Clinical Research Coordinator course .

Create Effective Documentation: Develop monitoring tools tailored to the protocol, including forms for recording information from site visits, source documents, data collection instruments, and case report forms (CRF). Additionally, establish a Monitoring Log or Tracking System to enhance accountability for study activities.

For detailed training on documentation practices, consider the Clinical Trials Assistant Training .

Conducting Monitors' Visits: Depending on the trial's complexity and regulatory mandates, execute pre-study qualification visits (PSQV), pre-initiation visits (PIV), initiation visits (IVs), periodic monitoring visits (PMV), and close-out visits (COV). Throughout each visit, uphold good clinical practice standards by thoroughly reviewing source documents and data collection instruments. Scrutinize patient enrollment logs for accuracy, noting any discrepancies in the comprehensive visit report.

The CRA course provides in-depth training for those looking to conduct these critical visits.

Reporting Findings: Create comprehensive yet succinct reports after each monitor's visit, offering clear recommendations for corrective actions as needed. Provide professional feedback to investigators, highlighting their performance. Identify and address any noncompliance with protocol requirements or regulations, suggesting training or educational sessions when necessary. Track all follow-up activities related to corrective actions taken in response to monitor's visit findings. Ensure the completion of essential documentation before closing out a specific study site.

Those interested in the oversight of safety reporting might explore the Pharmacovigilance Certification .

Ensuring Quality Assurance: Validate the accuracy of tracking systems employed by monitors during their visits. Assess the risks linked to identified deficiencies throughout the monitoring process. Conduct regular internal audits/assessments to guarantee compliance with established SOPs/guidelines pertaining to clinical research monitoring activities. Implement preventive measures based on audit/assessment results to enhance internal quality system processes.

Professionals aiming for a specialized role in this field might consider the Medical Monitor Certification .

Types of Clinical Trial Monitoring

Onsite Monitoring: Onsite monitoring, considered the "gold standard," entails a monitor's presence at a study site throughout the trial. The monitor reviews source documentation, including patient records, lab results, and investigational product dispensing logs, ensuring accuracy and compliance with study protocols and good clinical practices (GCP). Staff interviews verify proper adherence to trial procedures.

Centralized or Remote Monitoring in Clinical Trials: Centralized or remote monitoring allows sponsors to conduct clinical research monitoring without onsite visits. Leveraging technology like web portals and video conferencing, monitors remotely review data from multiple sites simultaneously. This method facilitates quick issue identification. Moreover, it enables proactive risk assessment before onsite visits, enhancing the efficiency of the monitoring process.

Types of Clinical Research Monitoring: Clinical research monitoring is a critical process that evaluates the quality and integrity of clinical trial data, ensuring adherence to regulatory requirements. Three primary methods are employed: onsite monitoring, centralized or remote monitoring, and risk-based approaches.

4. Risk-Based Approaches (2024): Embracing the advancements of 2024, risk-based approaches now leverage cutting-edge data analytics tools like advanced descriptive statistics and predictive algorithms. These tools identify potential trends or outliers in clinical trial data, signaling an increased risk of noncompliance with Good Clinical Practices (GCPs) or other regulations. Technology-driven approaches enable sponsors to detect issues earlier in a trial, allowing timely corrective action to prevent complications.

5. Benefits of Clinical Research Monitoring (2024): In the ever-evolving landscape of clinical research, effective monitoring strategies play a pivotal role in ensuring trials are conducted ethically, safely, and in accordance with protocol standards. Aligned with timelines agreed upon with regulatory authorities and budget constraints set by sponsors/CROs/investigators, these strategies provide invaluable insights. Acting as independent third parties, clinical research monitors offer objective perspectives across multiple sites, minimizing biases from investigators or personnel with vested interests.

Furthermore, contemporary monitoring ensures patient safety by overseeing the administration of drugs or medical devices and maintaining confidentiality throughout the study. Robust monitoring protocols also prove instrumental in reducing costs associated with potential delays, preventing errors throughout the trial duration, from pre-study startup to post-closeout when all enrolled patients have completed their participation.

Clinical Research Monitoring Guide

1. Mastering Clinical Research Monitoring in 2024:

Dive into the core of clinical research monitoring, a vital aspect of the research process ensuring both safety and result accuracy. Regular assessments of study sites verify proper data collection in adherence to ethical standards, legal requirements, and the latest Good Clinical Practice (GCP) guidelines.

2. Demystifying Monitored Study Types:

In the SEO landscape of 2024, clinical research monitoring extends beyond clinical trials to encompass observational studies, epidemiologic studies, and public health surveys. Understanding the specific study type being monitored is crucial for ensuring the correct procedures are implemented.

3. Navigating Study Site Monitoring:

Stay current with 2024 SEO standards by comprehending the intricacies of clinical research monitoring. The primary objective is meticulous confirmation that both protocol and informed consent forms are followed at each site. This involves in-depth reviews of relevant documents such as case report forms (CRFs), source documentation (e.g., physician notes), internal audit reports, and external quality assurance reports. Compliance with GCP guidelines during site visits or remote reviews, coupled with interviews assessing data collection and reporting processes, enhances the monitoring process.

4. Grasping Regulatory Requirements in 2024:

Beyond GCP guidelines, the SEO-friendly approach for 2024 emphasizes an awareness of applicable regulations from local governments or institutions. Adherence to these regulations is vital for compliance with laws related to clinical research monitoring activities.

5. Crafting an Advanced Monitoring Plan:

Elevate your monitoring plan in 2024 with a detailed timeline for site visits, specific focuses (e.g., patient enrollment/randomization, adverse event management), and strategies for auditing/reviewing generated data. Incorporate measures to control data collection risks, enabling early issue identification, aligning with SEO standards and ensuring a smooth study process.

Clinical Research Monitor Job

A Clinical Research Monitor plays a crucial role in ensuring the ethical and safe conduct of clinical trials while maintaining compliance with established standards. The primary focus is safeguarding the rights, safety, and well-being of human subjects participating in the trials. Responsibilities encompass a wide range of activities, including protocol development, coordination of study start-up, site visits, monitoring data accuracy and completeness, auditing files for regulatory compliance, managing investigator queries, preparing visit reports, reviewing protocol updates, resolving issues identified through audits, offering technical guidance to sites on protocol implementation, and escalating complex issues or potential risks.

Clinical Research Monitor Salary

The salary for this position varies based on factors such as education, experience, and geographical location. Entry-level positions may start at around $60,000 per year, while experienced professionals can earn up to approximately $90,000 per year. In addition to salary, many employers provide benefits such as paid vacation days, health insurance plans, and retirement packages.

Resources for Clinical Research Monitoring

1. national institutes of health (nih): clinical research monitoring.

This link provides information on NIH's guidelines for monitoring clinical research , which include topics such as the roles and responsibilities of the investigator, data safety monitoring boards, and protocols for reporting unanticipated problems and adverse events.

2. National Institutes of Health (NIH): Guide to Clinical Research Monitoring

This comprehensive guide walks readers through all aspects of clinical research monitoring , including topics such as study design, randomization strategies, regulatory compliance requirements, data management, monitoring plans and reports, quality improvement initiatives, and safety assessments.

3. US Food and Drug Administration (FDA): Guidelines for Clinical Trials Monitoring

This resource from the FDA outlines the importance of effective monitoring in clinical trials and provides an overview of the different roles within a clinical trial as well as details about essential elements for implementation of an effective monitoring strategy such as risk assessments and adverse event tracking.

4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

ICH has developed standards that provide a set of harmonized technical requirements for clinical trials conducted across countries in the European Union (EU), Japan, and US with an emphasis on quality assurance and safety monitoring during trials.

5. Association of Clinical Research Professionals (ACRP)

ACRP's guidelines provide best practice recommendations for conducting clinical research studies in accordance with applicable regulations and standards to ensure patient safety monitoring during studies as well as data integrity throughout the process from start to finish.

6. Pharmaceutical Research & Manufacturers of America (PhRMA)

The PhRMA guidelines provide an overview of expectations around clinical research activities with respect to ethics, data integrity, safety reporting, resource allocation and more. It defines roles and responsibilities of all those involved in overseeing a clinical trial such as a Clinical Research Monitor or CRA who has primary responsibility for ensuring that the protocol is implemented correctly throughout a study’s duration

Clinical Research Monitoring Review

1. What is the main purpose of clinical research monitoring?

A) To ensure that a research study is conducted in accordance with applicable regulations and ethical standards

B) To ensure that data collected during a research study is accurate and reliable

C) To evaluate the safety of participants enrolled in a research trial

D) To oversee the financial management of a research project

Answer: A) To ensure that a research study is conducted in accordance with applicable regulations and ethical standards. Clinical Research Monitors are responsible for ensuring compliance with Good Clinical Practice guidelines, protecting participant privacy, verifying data accuracy, and evaluating protocol deviations. In addition, they may also be involved in reviewing participant eligibility requirements, conducting site assessments, providing training to investigators and staff on proper study procedures, as well as monitoring progress towards completion of all requirements of the study.

2. What type of individuals typically serve as clinical research monitors?

A) Physicians

C) Regulatory specialists

D) All of the above

Answer: D) All of the above. Clinical Research Monitors can come from various backgrounds such as medical doctors (MDs), nurses (RNs), pharmacists (RPhs), regulatory specialists (e.g., Regulatory Affairs Professionals or Paralegals), or biostatisticians/data analysts who have experience in clinical trials and understand local regulations related to human subject protection. Each monitor has specific job duties depending on their education and experience, such as assessing compliance with regulatory guidance or analyzing data sets for accuracy, completeness, integrity, or validity.

3. What kind of activities do clinical research monitors need to perform?

A) Protocol reviews or verifications

B) Ensuring appropriate documentation completion

C) Site visits to observe investigator conduct

D )All of the above

Answer: D )All of the above. Clinical Research Monitors need to perform several activities including protocol reviews or verifications; ensuring appropriate documentation completion; site visits to observe investigator conduct; liaising between sponsors and sites; assisting with resolving issues associated with adverse events; reviewing case report forms for completeness, accuracy, consistency and correctness; evaluating subject safety throughout enrollment process;and writing reports detailing their findings at each visit.

4. What is one benefit gained from having an effective Clinical Research Monitor on-site? A) Reduced risk for legal liability stemming from negligence

B) Improved protocol adherence by investigators

C) Increased patient engagement during trial period

Answer: D) All of the above . An effective Clinical Research Monitor encompasses several benefits such as reduced risk for legal liability stemming from negligence due to thorough oversight and accurate record keeping; improved protocol adherence by investigators through continued communication between sponsor representatives and researchers on-site regarding best practices; increased patient engagement during trial period due to more detailed explanations about potential risks/benefits offered by having monitor on-site ; and improved efficiency when dealing with complex protocols that require multiple levelsof oversight due to familiarity with protocol specifics which decreases time spent troubleshooting errors or unclear instructions..

5. How often should Clinical Research Monitors visit a particular site?

A) Weekly B) Biweekly C) Monthly D) Quarterly

Answer: C) Monthly . It is recommended that Clinical Research Monitors visit sites at least once per month in order to maintain active surveillance over ongoing studies at each location while also providing timely feedback regarding any issues discovered while on-site visits are taking place within a shorter timeframe if needed based upon changes made midstream or other unanticipated circumstances which might require immediate attention by sponsor personnel.

Clinical Research Associate: A Full Guide on Becoming A CRA

Mastering the field: top 10 pharmacovigilance jobs demystified.

Transforming the understanding and treatment of mental illnesses.

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Data and Safety Monitoring Plan Writing Guidance

Guidance for developing a data and safety monitoring plan for clinical trials sponsored by nimh.

(Version date: April 16, 2015)

The National Institute of Mental Health (NIMH) has developed the following guidance for investigators developing a data and safety monitoring plan (DSMP) to ensure the safety of research participants and protecting the validity and integrity of study data in clinical trials supported by NIMH.

This guidance applies to data and safety monitoring for all NIMH-supported clinical trials (including grants, cooperative agreements, and contracts).

Introduction

It is the policy of the National Institutes of Health (NIH) that each Institute and Center (I/C) have a system in place for the appropriate oversight and monitoring of NIH-funded clinical trials . Accordingly, the NIMH has developed a Policy Governing the Monitoring of Clinical Trials . All grant applications and contract proposals for clinical trials submitted for NIMH Extramural funding must include a proposed DSMP as part of the research application’s “Human Subjects” section. In an effort to facilitate the development of a DSMP, the following guidelines have been provided to assist in protecting the health, rights, and safety of research participants.

Determining the Appropriate Level of Monitoring

The type of monitoring entity or monitoring plan may differ greatly between studies. All clinical trials will be monitored, at minimum, by the Principal Investigator (PI) and Institutional Review Board (IRB) and may require additional monitoring by an Independent Safety Monitor (ISM) or Data Safety Monitoring Board (DSMB) (See Policy Governing Monitoring of Clinical Trials ). The method or level of monitoring should correspond to the risk involved; the population being studied; and the size, scope, and complexity of the trial. For example, close monitoring by the PI may be an appropriate format for monitoring studies with low-risk interventions, however, in some instances, the Program Official (PO) , PI or the IRB may determine that an ISM may be required. The NIH requires data and safety monitoring for all clinical trials. Multi-site clinical trials and most phase III clinical trials will require monitoring in the form of DSMBs. In June 2000, the NIH issued further guidance on data and safety monitoring for phase I and phase II trials . The NIMH has developed guidance on risk-based monitoring to assist investigators with determining the appropriate level of monitoring for a given study.

Required Elements of a Data and Safety Monitoring Plan

A DSMP should include a general description of a plan establishing the overall framework for the oversight and monitoring of a study. When formulating the DSMP, the PI, and the study team should consider the protocol, phase, intervention(s), target population, subject safety and privacy, risks and benefits involved in the study, data integrity and confidentiality, study coordination, and how the team will address each of these elements. When modifications to the DSMP are made before the trial begins (e.g., in response to the peer review or IRB review), a final IRB-approved monitoring plan must be submitted to the NIMH PO prior to the commencement of human subjects activities. The minimum required DSMP content should include the following elements.

If these elements are noted elsewhere in the application or proposal, they need not be repeated but should be referenced in the DSMP section :

A brief description of the study design (e.g., interventions , procedures, tests and scans, biospecimen collection, interviews and focus groups, study visits)
Primary and secondary outcome measures/endpoints
Sample size and target population
Inclusion/exclusion criteria and how the criteria will be evaluated
For multi-site trials, a list of proposed participating clinical sites and data coordinating centers and a description of each site’s role
Identification and description of individuals responsible for monitoring the trial (e.g., PI, ISM, DSMB), their roles, qualifications, and the frequency of the monitoring activities. If the monitoring entity is an ISM or a DSMB, provide the NIMH PO and Office of Clinical Research (OCR) review with a list of the proposed membership and assurances to ensure that there are no conflicts of interest with the study team or proposed institutions.
Description of any specific events that would preclude a participant from continuing the intervention
Description of any procedures in place for managing any medication related issues (e.g., medication washout, allergic reactions, drug interactions, discontinuation/stoppage of medication, use of rescue mediations)
Description of the potential risks and the measures in place to protect participants against foreseeable risks
Description of the consent/assent procedures (e.g., by whom, how and under what conditions will a subject be consented)
Description of the mechanisms in place to protect subject privacy (e.g., interviews will take place in a private room, whether results of testing data will be shared with participant’s legally authorized representative, privacy for minors, secure means of communication between investigators and participant, e.g., telephone, web portal)
Description of the trial stopping rules for the study, if any (e.g., increased suicidal ideation, greater than expected morbidity or mortality rate)
Description of the plan for management of incidental findings (e.g., a brain tumor or potential structural abnormality discovered during a scan)
Description of the process for the disclosure of any conflicts of interest that may potentially challenge participant safety or bias the data and how the conflict will be managed
For multi-center studies, a description of the procedures for ensuring compliance with the monitoring plan including requirements for data reporting across study sites
Description of the data security in place to protect the confidentiality of the data (e.g., password protected encrypted electronic records) and any limits to confidentiality (e.g., suicidal ideation, child abuse)
Description of the process and timelines (e.g., hours, days) for collecting and reporting Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Problems Involving Risks to Subjects or Others to appropriate monitoring and regulatory entities (See NIMH Reportable Events Policy for definitions and timeframes )
Specific plan and timeframe for reporting IRB and/or ISM/DSMB actions to the NIMH (e.g., protocol violations, non-compliance, suspensions, terminations)
Identification of data sources (e.g., questionnaires, medical records, biospecimen collections, audio/video recordings)
Description of the security measures in place to protect data sources including how the data will be labeled and stored
Quality assurance measures for subject recruitment, enrollment, enrollment targets, and for the validity and integrity of the data. E6 Good Clinical Practice (R2): 1.46 defines quality assurance as “All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s)”

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What is the purpose of clinical trial monitoring?

Sharon b. love.

1 MRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ UK

Victoria Yorke-Edwards

Elizabeth ward.

2 Bristol Trials Centre (BTC), BRI Hub (CTEU Bristol), Level 7 Queens Building, Bristol Royal Infirmary, Marlborough Street, Bristol, BS2 8HW UK

Rebecca Haydock

3 Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK

4 NHS Blood and Transplant Clinical Trials Unit, Long Road, Cambridge, CB2 0PT UK

Katie Biggs

5 Clinical Trials Research Unit, ScHARR, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK

Gosala Gopalakrishnan

6 Department of Surgery & Cancer, Imperial College London, Hammersmith Campus, 1st Floor, ICTEM Building, Du Cane Road, London, W12 0NN UK

7 Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff University, 6th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK

Lydia O’Sullivan

8 Health Research Board - Trials Methodology Research Network, NUI Galway, University Road, Galway, Ireland

9 ICR-CTSU, 15 Cotswold Road, Belmont, Sutton, Surrey, SM2 5NG UK

Estelle Payerne

10 Norwich Clinical Trials Unit, Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ UK

Kerenza Hood

11 Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK

Garry Meakin

Associated data.

All data and material are given in paper and supplementary files.

The sources of information on clinical trial monitoring do not give information in an accessible language and do not give detailed guidance. In order to enable communication and to build clinical trial monitoring tools on a strong easily communicated foundation, we identified the need to define monitoring in accessible language.

In a three-step process, the material from sources that describe clinical trial monitoring were synthesised into principles of monitoring. A poll regarding their applicability was run at a UK national academic clinical trials monitoring meeting.

The process derived 5 key principles of monitoring: keeping participants safe and respecting their rights, having data we can trust, making sure the trial is being run as it was meant to be, improving the way the trial is run and preventing problems before they happen.

From the many sources mentioning monitoring of clinical trials, the purpose of monitoring can be summarised simply as 5 principles. These principles, given in accessible language, should form a firm basis for discussion of monitoring of clinical trials.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-022-06763-2.

The MRC-NIHR Trials Methodology Research Partnership (TMRP) Trial Conduct Working Group Data Quality and Monitoring (DQM) subgroup (hereafter “TMRP DQM”) comprises 13 people (authors of this paper) interested in improving the monitoring of clinical trials (four researchers, six trial managers, three other). Though location was not an exclusion when applications were requested for this subgroup, the current members are those involved in academic trials from the UK and Ireland, each involved in a variety of national and international trials. Despite each adapting our way of working from the guidance available, it was clear that we did not have a common monitoring strategy or understanding of terminology. We identified the need to go back to basics and define the purpose of monitoring. This will enable communication between researchers, regulators and trial teams and will give a strong easily explained foundation on which to build tools for clinical trial monitoring.

Clinical trial monitoring is an important aspect of clinical trial conduct. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) E6(R2) [ 1 ] gives a definition of the purpose of clinical trial monitoring

“5.18.1 Purpose The purposes of trial monitoring are to verify that: (a) The rights and well-being of human subjects are protected. (b) The reported trial data are accurate, complete, and verifiable from source documents. (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).”

Though ICH GCP has used this underlying definition of the purpose of monitoring since 1996 [ 1 ], it is not written in accessible language and does not contain any explicit detailed guidance on monitoring activities [ 2 ]. Therefore, each clinical trial sponsor has taken this definition or the one in their own country’s legislation (for example [ 3 ]), interpreted it and created their own monitoring activities. This has led to wide variation in practices, as noted in several surveys of monitoring approaches [ 4 – 6 ].

Despite the recent shift towards a more risk-based approach, which has led to a re-focusing on monitoring, there remains little detailed guidance available on how it should be done. To facilitate the development of any guidance in the future, a clear understanding of the purpose of monitoring is essential.

This paper describes the process whereby the MRC-NIHR TMRP DQM extracted the purpose of monitoring, as described by pertinent sources, and from them defined the purpose of monitoring in accessible language. We hope that this paper can be used to formulate detailed guidance on how to monitor clinical trials.

We chose the sources from guidance provided by organisations that any one of the TMRP DQM referred to when deciding how to run trials. Table Table1 1 gives the organisations included and their aims. Each author reviewed an organisation’s publicly available online or downloadable information to extract any material on the purpose of monitoring. We did not contact the organisations. The documents reviewed included guidance documents, minutes of workshops, toolkits, blogs and reports of questions and answers (Additional file 1 ). In a second round, the information related to the purpose of monitoring was distilled into non-repetitive statements by pairs of authors. In the final round, all authors independently compared the purpose of monitoring across all sources and in the ensuing consensus meeting five key principles for the purpose of monitoring emerged.

Descriptions of the organisations publishing on monitoring from the organisation website

Organisation and URL	Short name	Description
Clinical Trials Transformation Initiative	CTTI	Mission: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. CTTI comprises more than 80 organizations from across the clinical trial enterprise. USA based private body, International
European Medicines Agency	EMA	The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. Public body, European Union
US Food and Drug Administration	FDA	The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. Public body, USA and further afield
Health Research Authority	HRA	[HRA] vision is for high-quality health and social care research that improves people’s health and wellbeing, and [HRA] core purpose is to protect and promote the interests of patients and the public in health and social care research. Public body, UK
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use	ICH	Brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Private body, International
Medicines and Healthcare products Regulatory Agency	MHRA	Regulates medicines, medical devices and blood components for transfusion in the UK. Public body, UK
National Institute for Health Research	NIHR	The UK's largest funder of health and care research and provide the people, facilities and technology that enables research to thrive. Working in partnership with the NHS, universities, local government, other research funders, patients and the public, [NIHR] deliver and enable world-class research that transforms people's lives, promotes economic growth and advances science. Public body, UK
TransCelerate Biopharma Inc	Trans-Celerate	Aim to collaborate across the global biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines. USA based, international
UK Trial Manager Network	UKTMN	Aims to facilitate the development of a well-trained, highly motivated, effective workforce of trial managers within the UK health care system who will make an important contribution to the efficient delivery of high quality clinical trials. Private body, UK

Organisation and URL

Short name

Description

Clinical Trials Transformation Initiative

CTTI

Mission: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials.

CTTI comprises more than 80 organizations from across the clinical trial enterprise.

USA based private body, International

European Medicines Agency

EMA

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

Public body, European Union

US Food and Drug Administration

FDA

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

Public body, USA and further afield

Health Research Authority

HRA

[HRA] vision is for high-quality health and social care research that improves people’s health and wellbeing, and [HRA] core purpose is to protect and promote the interests of patients and the public in health and social care research.

Public body, UK

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

ICH

Brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.

Private body, International

Medicines and Healthcare products Regulatory Agency

MHRA

Regulates medicines, medical devices and blood components for transfusion in the UK.

Public body, UK

National Institute for Health Research

NIHR

The UK's largest funder of health and care research and provide the people, facilities and technology that enables research to thrive. Working in partnership with the NHS, universities, local government, other research funders, patients and the public, [NIHR] deliver and enable world-class research that transforms people's lives, promotes economic growth and advances science.

Public body, UK

TransCelerate Biopharma Inc

Trans-Celerate

Aim to collaborate across the global biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines.

USA based, international

UK Trial Manager Network

UKTMN

Aims to facilitate the development of a well-trained, highly motivated, effective workforce of trial managers within the UK health care system who will make an important contribution to the efficient delivery of high quality clinical trials.

Private body, UK

To obtain feedback on their value, we presented the five key principles covering the purpose of monitoring to delegates at the UKCRC Task and Finish Monitoring Group annual meeting 2021 (a national meeting of experts in conducting academic clinical trial monitoring in the UK) and asked “Are there any of these purposes of monitoring that you do not agree with?”, giving options to disagree with any principle or to answer “No, I agree with all 5 proposed principles”. In addition, delegates were asked to suggest any other potential “principles of monitoring” that we should consider (see Additional file 2 ).

We show the underlying text for these five principles and also give examples of which monitoring activities could happen within each of these principles. We also present the results of our poll of the annual meeting.

The results of our synthesis for the purpose of monitoring are given in Table Table2 2 and include five principles. The purpose of monitoring is keeping participants safe and respecting their rights, having data we can trust, making sure the trial is being run as it was meant to be, improving the way the trial is run and preventing problems before they happen. In our poll at a national meeting of those monitoring clinical trials in the UK, 93 attendees voted, with 85% (80/93) agreeing with all 5 proposed principles for the purpose of monitoring (Table (Table3). 3 ). One poll respondent suggested adding building relationships with sites as a principle.

Purpose of monitoring key principles synthesised from major worldwide organisations

Purpose of monitoring
Key principles in lay terms	Key principles in more technical language
Keeping participants safe and respecting their rights	To ensure, enhance and protect participants’ safety, wellbeing and rights.
Having data we can trust	Having the systems and processes (such as source data verification) to ensure that each data item is as reliable as is needed to be sure of the results of the trial
Making sure the trial is run as it was meant to be	Maintain trial integrity by ensuring the trial is conducted in compliance with the currently approved protocol/documentation, with GCP and with the applicable regulatory requirements
Improving the way the trial is run	Improving quality, conduct and efficiency in clinical trials.
Preventing problems before they happen	Contingency and mitigation planning for risks to both participant safety and trial processes.

Results from poll about the principles of monitoring at national meeting of those monitoring academic clinical trials in the UK

Response to the question “Are there any of these that purposes of monitoring that you do not agree with?“ from 93 respondents	(%)
Keeping participants safe and respecting their rights	1 (1%)
Having data we can trust	2 (2%)
Making sure the trial was run as it was meant to be	3 (3%)
Improving the way the trial is run	8 (9%)
Preventing problems before they happen	4 (4%)
No – I agree with all 5 proposed principles	80 (86%)

Note that there were 93 respondents; some did not agree with more than one principle

Table Table4 4 shows the clarification of our derivation of these principles by giving examples from the underlying sources. For example, the principle “having data we can trust” came in part from the CTTI statement “Ensuring that data quality is sufficient to answer study question”. In Additional file 3 , we give the full text from all sources.

Showing the link of the 5 principles of monitoring with the sources

Principle of monitoring in lay terms	Examples of principle source	Source
Keeping participants safe and respecting their rights	Protecting the rights, safety, and welfare of subjects under the investigator’s care	FDA
	The risk associated with the IMP should also determine the trial procedures for monitoring the safety of participants.	MHRA
	Inspectors should verify procedures for reviewing and communicating findings that could adversely affect the safety of subjects.	EMA
	[…] safety must be monitored in all trials and therefore the need for formal procedures to cover early stopping for safety reasons should always be considered.	ICH E9 3.4
	[…] adequate oversight and monitoring during the trial will help ensure that trial subject safety is maintained throughout the trial.	NIHR
Having data we can trust	Careful attention to quality during trial planning, investigator training, trial monitoring and audit will help consistently achieve trial quality required.	ICH
	Ensuring that data quality is sufficient to answer study question.	CTTI
	Monitoring strategies, tailored to risks, should permit timely oversight and be focused on critical processes and critical data.	TransCelerate
	Appropriate planning before the trial and adequate oversight and monitoring during the trial will help ensure that trial subject safety is maintained throughout the trial and that there is accurate reporting of results at its conclusion.	NIHR
	Ensure … data quality across sites.	FDA
Making sure the trial was run as it was meant to be	[…] preventing or mitigating important and likely sources of error in the conduct, collection, and reporting of critical data and processes necessary for human subject protection and trial integrity.	FDA
	[…] perform checks that include: verification that trial documents exist, assessment of the site’s understanding of, and compliance with the protocol and trial procedures […]	NIHR
	Essential documents are those ‘documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced’ and they serve to demonstrate compliance with the principles of GCP and regulatory requirements.	UKTMN
	Investigators are appropriately selected, trained and supported to complete the proposed clinical trial (MHRA).	MHRA
Improving the way the trial is run	Monitoring during the trial will help ensure that trial subject safety is maintained throughout the trial and that there is accurate reporting of results at its conclusion.	NIHR
	Monitoring strategies, tailored to risks, should permit timely oversight and be focused on Critical Processes and Critical Data. Notably, Investigators are responsible for their site’s data quality and are expected to partner with the Sponsor to address, resolve, and prevent issues.	TransCelerate
	Chief investigators are responsible for the overall conduct of a research project including adhering to the agreed procedures and arrangements for reporting (e.g. progress reports, safety reports) and for monitoring the research, including its conduct, the participants’ safety and well-being and the ongoing suitability of the approved proposal or protocol in light of adverse events or other developments.	HRA
	Moreover, a risk-based approach is dynamic, more readily facilitating continual improvement in trial conduct and oversight. For example, monitoring findings should be evaluated to determine whether additional actions (e.g. training of clinical investigator and site staff, clarification of protocol requirements) are necessary to ensure human subject protection and data quality across sites.	FDA
	Maximizing efficiency for minimal resource use	CTTI
Preventing problems before they happen	Sponsors should prospectively identify critical data and processes, then perform a risk assessment to identify and understand the risks that could affect the collection of critical data or the performance of critical processes, and then develop a monitoring plan that focuses on the important and likely risks to critical data and processes.	FDA
	A Trial Monitoring Plan will be developed and agreed by the Trial Management Group (TMG), TSC and CI based on the trial risk assessment which may include on site monitoring. This will be dependent on a documented risk assessment of the trial.	HRA
	The sponsor should develop a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial. The plan should describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods to be used, and the rationale for their use. The plan should also emphasize the monitoring of critical data and processes.	ICH
	Once developed, the risk assessment and associated management/monitoring plans would form the basis of a common understanding by all stakeholders on the risks for that trial and facilitate a risk-proportionate approach to the trial activities.	MHRA
	Risk-based monitoring: An adaptive approach [to clinical trial monitoring] that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact subject safety and data quality.	TransCelerate

a This is not exhaustive. It is a selection of examples from a selection of sources for illustration

We have given examples in Table Table5 5 from sources and from our experience to show how each principle may be mitigated by monitoring. For example, if the principle of monitoring is to keep participants safe and respect their rights, then we should monitor to ensure the consent is valid.

Examples of monitoring for each principle

Principle	Examples
Keeping participants safe and respecting their rights	Ensure valid consent by checking the consent forms are completed correctly Ensure data available by checking that the expected data have been entered onto the database Look regularly at the amassed safety data and protocol compliance. Present to regulatory authorities, CI, DMC, TMG, REC and safety review committee and act upon their direction/advice. This may result in a change to the protocol or trial conduct.
Having data we can trust	Develop a risk-based monitoring plan that identifies critical data and processes and focusses on ensuring their accuracy and integrity. Perform on-site and/or remote monitoring and/or central monitoring, where required. Build quality into the scientific and operational design and conduct of clinical trials including an audit programme to evaluate processes relating to data quality and perform root cause analysis and establish corrective and preventative actions where significant deficiencies are detected.
Making sure the trial was run as it was meant to	Ensure site staff are appropriately trained and qualified to deliver their role on the trial and to follow trial specific procedures and processes (e.g. monitoring delegation and training logs, checking CVs). Collect and check protocol deviations/non-conformances and ensure systems are in place to mitigate risks of these happening again such as retraining and providing working practice documents. Ensure a monitoring plan is in place that allows timely evaluation of significant issues identified.
Improving the way the trial is run	Ensure the trial adheres to GCP, protocol and ethical/regulatory guidelines. Ensure quality measure are reached by providing adequate staffing and resources. Continuously monitor and respond to issues in a timely manner with corrective actions when required/appropriate
Preventing problems before they happen	Base the monitoring plan and activities on a risk assessment Undertake a risk assessment to assess the potential risks and puts things in place to prevent and monitor these risks.

We have clarified the purpose of monitoring in accessible language from pertinent sources. This will enable communication between those carrying out clinical trial monitoring and facilitate the building of clinical trial monitoring tools on a strong easily communicated foundation.

Clinical trial monitoring is a crucial part of trial conduct, improving the safety of the participants, the quality of the data and the trial integrity. Clinical trial monitoring is conducted by monitors, quality assurance teams and by trial managers [ 5 ]. Guidance on trial monitoring is spread amongst different sources within and between organisations, is often in technical language and does not describe practicalities of how to achieve the monitoring aims. The differing specialities conducting monitoring and the disparity and high-level content of the sources mean there is scope for misunderstanding and communication errors. This could easily lead to poor quality monitoring which could jeopardise the protection of the rights and safety of patients and the data and trial integrity. Also, misunderstanding could lead to over-monitoring for no additional value, placing additional burden on research teams and sites and increasing the cost of undertaking research. It is difficult to have methodology research discussions, and therefore to deliver monitoring tools, without agreement of a common basis which multiple disciplines can all understand. It is difficult for grant committees to understand the value of monitoring research when there is no easily understandable consensus on why we need to do good clinical trial monitoring. The differing language and range of ideas on clinical trial monitoring are confusing and unhelpful. The variability in language and practices this range has caused, as evidenced by 13 people in the UK who were experienced in clinical trial monitoring finding it difficult to communicate and find common ground, is limiting progress in clinical trial monitoring. We have synthesised the sources to describe the purpose of monitoring in five key principles described in both technical and lay language (Table (Table2). 2 ). We intend this to be a basis for making monitoring more accessible.

The purpose of monitoring principles presented in this paper are active, continual and responsive to monitoring findings. They are focussed on the conduct of a real trial rather than based on theory. They are aimed at monitoring to intervene and make trials better rather than certifying what has already been done. Monitoring is an integral part of trial conduct rather than an add-on. Our first three principles link with parts a, b and c of the ICH definition of monitoring (see methods) but the idea of improving trials or preventing problems before they happen is not part of the ICH definition. These are important aspects of monitoring, as finding an issue at one site early in the trial means that training can be given to the other sites and the overall trial is improved to the benefit of current and future patients. Stating improvement and prevention in our principles will help those running trials to address improvement to the trial and prevent poor conduct.

The FDA provided particularly valuable sources for this paper as they have strongly advocated risk-based monitoring and have had to be clear in their documents as they are extensively used worldwide.

Supplementary Table 2 lists the sources used. Although the thirteen authors all have experience of clinical trial monitoring in the UK and Irish academic setting, relevant and valuable sources of information may have been missed. The first selection of useful text from the individual documents within each source was done by one author and the second phase by groups of two or three. Only the final phase was completed by all authors together. These are limitations in the study but it also exemplifies how those devising monitoring policies for their trials and those carrying out monitoring activities must refer to multiple sources. The 86% vote of agreement with the five principles at the UK monitoring meeting corroborates the work done.

Though there is a limitation due to this work using world-wide English language sources, being led by UK and Ireland researchers and being corroborated in a UK national meeting, it is based on sources that are used by many. In future, it would be good to extend this to more of the clinical trial monitoring community world-wide.

Although building relationships with sites has been noted as a useful part of monitoring in publications [ 7 – 9 ], this did not come through from the sources reviewed and was only mentioned by one poll respondent at the national monitoring meeting. At present, we do not note it as one of the main five principles but further work may add principles.

As each group leading clinical trials has created their own monitoring strategy and language, there have been difficulties in communicating between groups [ 5 ]. Our principles clarifying the purpose of monitoring should improve communication and enable the monitoring community to start producing clear monitoring practical guidelines and to start sharing tools. These principles should be considered when undertaking risk assessments, developing monitoring plans and carrying out monitoring activities.

Conclusions

From the many sources mentioning monitoring of clinical trials, the purpose of monitoring can be summarised simply as (i) keeping participants safe and respecting their rights, (ii) having data we can trust, (iii) making sure the trial is being run as it was meant to be, (iv) improving the way the trial is run and (v) preventing problems before they happen.

Acknowledgements

We thank Shaun Treweek for his guidance in the early stages of this work.

Abbreviations

COVID-19	Coronavirus disease 2019
CTTI	Clinical Trials Transformation Initiative
CTU	Clinical Trials Unit
EMA	European Medicines Agency
FDA	US Food and Drug Administration
GCP	Good Clinical Practice
HRA	UK Health Research Authority
ICH	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
MHRA	Medicines and Healthcare products Regulatory Agency
NIHR	National Institute for Health Research
UKTMN	UK Trial Managers Network

Authors’ contributions


Sharon B Love	√	√	√	√
Victoria Yorke-Edwards	√		√	√
Garry Meakin	√		√	√
Elizabeth Ward	√		√	√
Rebecca Haydock	√		√	√
Katie Keen	√		√	√
Katie Biggs	√		√	√
Gosala Gopalakrishnan	√		√	√
Lucy Marsh	√		√	√
Lydia O’Sullivan	√		√	√
Lisa Fox	√		√	√
Estelle Paverne	√		√	√
Kerry Hood	√		√	√

Authors’ information

All authors are members of the MRC-NIHR Trials Methodology Research Partnership Trial Conduct Working Group Data Quality and Monitoring subgroup.

SBL and VYE were funded by MRC grant MC_UU_00004/08. LOS is funded by the Health Research Board-Trials Methodology Research Network grant (HRB-TMRN-2017-1).

Availability of data and materials

Declarations.

Not applicable.

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Contributor Information

Sharon B. Love, Email: [email protected] .

Victoria Yorke-Edwards, Email: [email protected] .

Elizabeth Ward, Email: [email protected] .

Rebecca Haydock, Email: [email protected] .

Katie Keen, Email: [email protected] .

Katie Biggs, Email: [email protected] .

Gosala Gopalakrishnan, Email: [email protected] .

Lucy Marsh, Email: ku.ca.ffidrac@LLhsraM .

Lydia O’Sullivan, Email: [email protected] .

Lisa Fox, Email: [email protected] .

Estelle Payerne, Email: [email protected] .

Kerenza Hood, Email: ku.ca.ffidac@1KdooH .

Garry Meakin, Email: [email protected] .

NINDS Guidelines for Monitoring in Clinical Trials

NINDS and NIH has developed policies and guidelines for monitoring clinical trials. The following websites provide information that may be useful in the conduct of a clinical research project:

This document describes the policies and procedures of the NINDS for monitoring interim data from ongoing clinical trials, including data summarizing study performance and the safety and efficacy of the treatment regimens. The procedures outlined herein are in addition to –and not in lieu of– IRB, OHRP and FDA requirements, and any additional applicable NIH guidelines.

2. NINDS Requirements for Monitoring

The NINDS requires that each clinical trial it supports, regardless of phase, has data and safety monitoring procedures in place to safeguard the well-being of study participants and to ensure scientific integrity. Monitoring must be performed on a regular basis throughout the participant accrual, treatment, and follow-up periods.

Monitoring activities should be appropriate to the trial phase, participant population, research environment, and degree of risk involved. Although the study PI will include a data and safety monitoring plan in his/her grant application, the level of monitoring required for each study is determined by NINDS staff and communicated to the study PI before the trial begins. No study may begin enrolling participants until the monitoring authority has been put into place and approved the study protocol.

A preliminary monitoring plan must be submitted as part of the Research Plan portion of the grant application for a clinical trial. The plan will be examined as part of the peer review process, and any comments and concerns will be included in the summary statement. NINDS staff will ensure that all concerns are resolved before the study begins enrollment.

In addition to the plans for safety monitoring, the NINDS requires that the protocol when applicable include a section describing the plan for interim analyses, the timing of the interim analyses relative to study events (e.g., "when 20 participants have completed 6 months of follow-up"), and the exact statistical analyses plans. The NINDS requires that the interim analyses and their effect on alpha be pre-specified. The NINDS also requires that any plans to adapt (e.g., sample size, randomization) be pre-specified and supported by relevant simulations when applicable. Any decision rules (e.g., for stopping or pre-planned adaptation) must be clearly stated. The interim analysis plans and statistical analysis plans are reviewed by the DSMB and may be modified by the DSMB.

As mentioned earlier, the NINDS may require a higher level of monitoring than is specified in the PI’s preliminary Data and Safety Monitoring Plan . In addition, the plan may be further modified in accordance with the IMM’s, the SMC’s or the DSMB’s requirements, both before the study starts enrollment and possibly mid-study.

NINDS will specify one of the several levels of monitoring:

Data and Safety Monitoring Board: typically for multi-center intervention trials or higher risk studies
Study Monitoring Committee: typically for single-center intervention trials or moderate risk studies
Independent Medical Monitor: typically for single-center intervention trials with lower risk
Monitoring by the study PI and local IRB

Each study must have only one monitoring authority.

2.1 Responsibilities of Data and Safety Monitoring Boards

Data and safety monitoring responsibilities for clinical trials consist of review of the research protocol and ongoing study activities, including review of data quality and completeness, review of fidelity to the study protocol, review of adequacy of participant recruitment and retention, review of adverse events, making recommendations to the NINDS and the study PI concerning trial continuation, modification, or conclusion. More details about the role of a DSMB are presented in Section 3, below.

2.2 Responsibilities of the Study Monitoring Committee

Studies not monitored by a DSMB may be overseen by a Study Monitoring Committee. SMC members (generally physicians and a statistician) will be appointed by the study PI in consultation with the NINDS and must be independent of the study, but can be from the same institution, unless the NINDS requires otherwise. The NINDS Program Official must approve the SMC membership and the specific monitoring procedures, and may participate in SMC meetings.

2.3 Responsibilities of the Independent Medical Monitor

An Independent Medical Monitor should be appointed by the study PI to oversee a clinical research project if there is more than minimal risk to the participants, but the study is not sufficiently complex that a DSMB or SMC is necessary. The IMM must be independent of the study and have no real or apparent conflict of interest. The NINDS Program Official must approve of the IMM and specific monitoring procedures she/he will follow. The IMM will operate in a manner similar to that of a SMC/DSMB. At each monitoring interval, the NINDS Program Official will receive notification by the IMM that he/she has reviewed the research protocol and ongoing study activities with emphasis on data integrity, protocol adherence and study participant safety issues. The IMM’s review will focus on AEs and reasons for losses to follow up, raising any concerns or issues with the NINDS and the PI, and recommending to the NINDS and PI the continuation, modification or conclusion of the trial, while protecting the confidentiality of the trial data and the results of monitoring.

The Independent Medical Monitor role is distinct from the role of a Medical Safety Monitor. The MSM role is described below under section 2.5.

2.4 Responsibilities of the PI and IRB

When a trial is of minimal risk or even if it is of more than minimal risk but involves only a single site, and if the trial involves only one intervention, the NINDS may determine that the study may be adequately monitored by the study PI and his/her IRB. It is expected that the PI will be actively involved in reviewing the progress of each subject on study and will bring to the attention of the IRB adverse events and unexpected problems that may influence the IRB’s decision to allow the trial to continue, in accordance with the IRB’s policies. In addition, the PI is expected to notify the NINDS Program Official.

2.5 Responsibilities of the Medical Safety Monitor

Each multi-center clinical trial supported by the NINDS will have an independent Medical Safety monitor (MSM), nominated by the study PI before participant enrollment begins and subsequently approved by the NINDS Program Official and by the NINDS DSMB, if applicable. The MSM is a physician who is not involved in the study and who has no conflict of interest. The MSM is responsible for ongoing monitoring of reports of SAEs submitted by the clinical centers in real time to ensure good clinical practice and to identify safety concerns quickly. The MSM may suggest protocol modifications to prevent the occurrence of particular AEs, e.g., modifying the protocol to require frequent measurement of laboratory values predictive of the event or to improve expeditious identification of SAEs. To minimize bias, the MSM will usually evaluate SAEs blinded to treatment assignment, unless the DSMB/SMC approves partial or complete unblinding. Specific procedures for MSM activities will necessarily vary from trial to trial. For certain trials, the MSM may serve as a resource to the clinical investigators for advice about management of SAEs but may not be involved in other aspects of the trial. The responsibilities of the MSM are worked out between the Steering Committee and DSMB/SMC in advance of starting the trial.

The MSM will prepare regular reports concerning SAEs (not segregated by treatment group) for submission to the PI, and subsequently to the DSMB and, as appropriate, the FDA and collaborating biopharmaceutical companies or device manufacturers. Typically, such reports will be submitted on a regular basis, to be determined by the DSMB. In the event of unexpected SAEs or an unduly high rate of SAEs, the MSM will promptly contact the PI and the NINDS Program Official and, if applicable, the NINDS DSMB Liaison, who will notify the DSMB Chair. The DSMB/SMC may convene a meeting or teleconference to consider the concerns and plan appropriate action. In the event that the MSM is unavailable for an extended period of time (i.e., extended vacation, sabbatical, illness, etc.) a back-up MSM will be nominated by the study PI and approved by the NINDS Program Official.

3. Data and Safety Monitoring Board

3.1 overview.

An NINDS-appointed DSMB is required for trials which may modify the current standards of treatment or public health policy, result in the licensing of a therapeutic agent or device, or extend approved indications to new groups of patients. A DSMB is mandatory for all Phase 3 clinical trials, and it may be required for some earlier phase trials (e.g., trials that involve multiple sites, pose significant risk to participants, are conducted in vulnerable populations, use certain controversial interventions).

The DSMB will meet regularly in person or by teleconference, typically on a semi-annual basis, to monitor the cumulative safety data during participant follow-up. The in- person format is recommended for the initial meeting and then annually, when possible. In no instance should more than 12 months elapse between DSMB reviews of cumulative safety data after the first participant has enrolled. The DSMB will monitor the study according to the guidelines specified in the study protocol and the operating procedures established at the initial meeting, unless the DSMB determines during the course of the trial that modification of the guidelines is in the best interest of the study and its participants.

Except as explicitly authorized by the DSMB, it is critical that study investigators will remain masked to the interim data because knowledge of emerging trends between treatment arms may influence participant enrollment, management and evaluation, thus compromising the study by introducing bias. The DSMB decides in their first meeting if DSMB members will be unmasked. If the DSMB decides to remain masked, they should consider assigning one DSMB member, when possible a clinician, to be unmasked to treatment assignment. The unmasked DSMB member may decide to unmask other DSMB members as indicated, and for example based on concerns over SAE imbalances between study groups.

3.2 Responsibilities of the DSMB

The DSMB is responsible for assuring the NINDS that study participants are not exposed to unnecessary or unreasonable risks and that the study is being conducted according to high scientific and ethical standards. Specifically, the DSMB will:

Assess the performance of the trial with respect to participant recruitment, retention and follow-up, protocol adherence, and data quality and completeness, in order to ensure the likelihood of successful and timely trial completion.
Review the statistical analysis plan, including the interim analysis plan, stopping rules and randomization scheme
Monitor interim data regarding the safety and efficacy of the study regimens, so that the trial will be concluded as soon as there is convincing evidence of the treatment effects.
Review abstract and publications of main findings prior to submission to ensure the study is being reported appropriately.
Review and consider any protocol modifications proposed by the study investigators after the main trial begins to ensure that these do not negatively impact on the main trial. Protocol modifications will be considered in the context of their potential impact on scientific integrity and participant safety.
Monitor recruitment progress.
Monitor lost to follow-up.
Review data completeness and quality.
Monitor missing data.
Recommend planned adaptations based on pre-specified plans and decision rules.
Review and consider any ancillary studies proposed by the study investigators to ensure that they do not have a negative impact on the main trial.
Review performance and participant safety data of active ancillary studies.

After each review, the DSMB will advise the NINDS and the study investigators as to whether a protocol should continue as scheduled or undergo a modification due to findings that emerged as a result of the monitoring process.

3.3 DSMB Membership

The NINDS-appointed DSMB has an advisory role to the institute. The voting members may include physicians, laboratory scientists, statisticians, ethicists and patient advocates. Collectively, they will have appropriate expertise in the relevant scientific and safety monitoring areas. The precise number of DSMB members and their areas of expertise will be dictated by the complexity of the study. Study PIs may suggest to the NINDS appropriate individuals to serve on the DSMB.

One member of the DSMB is designated as the DSMB Chair. The DSMB Chair is typically a physician.

To avoid any appearance of conflict of interest, it is critical that DSMB members not be involved in the study, have no vested interest in its outcome, and have no financial ties to any commercial concerns likely to be affected by the study's outcome. In general, DSMB members do not publish study related manuscripts with study team members, while a study is on-going, in order to prevent any possible or perceived conflicts of interest. If at any time a DSMB member perceives that he/she or another member of the Board has a potential conflict of interest, he/she is obligated to bring the issue to the attention of the full DSMB for open discussion and resolution. The NINDS requires DSMB members to complete a conflict of interest disclosure form and a statement of confidentiality (pdf, 40 KB) ( pdf, 39 kb ), on an annual basis.

The principal contact between NINDS and the DSMB is the DSMB liaison, who must maintain objectivity regarding trial outcomes to avoid influencing the DSMB, and confidentiality of DSMB discussions to avoid influencing trial conduct. The NINDS DSMB liaison, who serves as the principal contact between NINDS and the DSMB, is the federal government representative on the DSMB.

3.4 Role of the Independent Statistician

An independent statistician (as distinct from the study statistician) will be responsible for generating the unblinded interim analyses (i.e., closed session DSMB reports) and reporting to the DSMB; this statistician will have no other involvement in the trial. The purpose for having an independent statistician is to help ensure that interim results from the trial will be kept confidential and that the Steering Committee will not be influenced by any knowledge of the study’s interim results.

Most trials supported by NINDS are funded through a grant awarded to a single organization, usually an academic institution. The Principal Investigator is generally the director of the Clinical Coordinating Center for the trial and the chair of the Steering Committee. A Statistical Analysis Center and a Data Management Center (or a combined Statistical and Data Management Center) are usually funded through subawards. Both the study statistician and the independent statistician will typically be employees of the Statistical Analysis Center. Despite these structural and financial arrangements, it will be necessary for a ‘firewall’ to be established to ensure that the independent statistician can operate autonomously from the Principal Investigator, study statistician and other members of the Steering Committee.

The Data and Safety Monitoring Plan in the grant application must describe the proposed firewall and how it will function to protect the quality and confidentiality of the interim data and related DSMB analyses. Close adherence to the interim monitoring procedures outlined in the study-specific Statistical Analysis Plan (SAP) will help mitigate possible bias and preserve trial integrity. Nevertheless, because DSMBs frequently need to modify these plans (e.g., to account for an unexpectedly low overall event rate), the Data and Safety Monitoring Pland and the SAP should clearly state that there must not be any restrictions on the data the independent statistician can access or the extent or timing of interim analyses he/she can perform, without alerting any member of the Steering Committee.

Despite the firewall, the independent statistician must be thoroughly familiar with the trial protocol, the SAP, the case report forms, and the processes for data collection and adjudication of safety and outcome events. One way to achieve this may be to allow the independent statistician to work closely with the study statistician and data managers up until the point where the first interim analysis report is generated for the DSMB, at which time the firewall is implemented.

3.5 Initial Meeting

The first DSMB meeting takes place before the study is opened to participant accrual, with the goal of reviewing the study protocol, particularly the specific outcome definitions, the analysis plan, the procedures for recording and reporting SAEs, the monitoring proposal, pre-specified interim analysis plan and decision rules, and pre-specified plans for adaptation and decision rules. The informed consent document/process also will be inspected to ensure that all required elements have been included in language understandable to a typical study participant to be enrolled in the trial. It is possible that the DSMB will recommend modification or clarification of the protocol, especially relating to the monitoring plan. A carefully considered, final monitoring plan is important to establish at the outset, because any subsequent deviation from the pre-specified plan may diminish the scientific integrity and credibility of the study.

During this initial meeting, the DSMB liaison will explain the stewardship roles of NINDS staff who attend DSMB meeting as observers, and his/her responsibilities as the principal contact between the DSMB and NINDS, and the DSMB and PI. The DSMB will review the DSMB guidelines and formulate its operating procedures, including: the DSMB's meeting frequency; the types and formats of reports it will receive from the PI and independent statistician, what interim data (if any) may be released to the study investigators (e.g., overall event rate); and how minutes will be taken and distributed. In addition, at the first meeting, the policy regarding masking of the DSMB members with respect to group data should be established. DSMB data reports typically present closed session data by coded treatment group (e.g., “A/B”). It is highly recommended that the DSMB have knowledge from the start of the study which treatment groups the codes represent. If the DSMB initially elects to remain masked to these codes, the key must be available should the need for full unmasking arise.

3.6 Meeting Format

The NINDS DSMB meeting format consists of open and closed sessions. The meeting format, including the number of open and closed sessions, and the participation in these sessions is at the discretion of the DSMB. The DSMB Chair, in conjunction with the NINDS DSMB liaison, is responsible for the DSMB operations and will set the meeting agenda. At each meeting, the DSMB liaison will update conflict of interest and remind DSMB members that NINDS staff attend as observers only.

Closed Sessions: Only DSMB members and the NINDS DSMB liaison participate in closed sessions, to ensure complete objectivity as they discuss outcome results by treatment arm as needed, make decisions, and formulate recommendations regarding the study. The DSMB Chair may request additional participants during this session, e.g. medical safety monitor, independent statistician.

Open Sessions : DSMB members, NINDS Project Scientist assigned to this study, NINDS Program Official assigned to this study, NINDS DCR director or designee, study PIs, study statistician and independent statistician attend this session, at which data concerning study conduct and aggregate safety data are discussed.

If a DSMB member has concerns with NINDS staff attendance or participation at any of the above meetings, these should be addressed either to the DSMB liaison or to the NINDS DCR Director or designee.

3.7 Interim Data Reports

The format and reporting requirement of unmasked data should be discussed and agreed upon at the first DSMB meeting. At least 14 days prior to the meeting, the independent statistician will prepare study reports using the most recent data and send these to the NINDS DSMB liaison, who will provide the meeting materials to the DSMB members.

Interim data reports will usually consist of two parts, corresponding to the Open and Closed Sessions of the DSMB meeting. Only the DSMB members will receive copies of the Closed Session report, and at the conclusion of the meeting the independent statistician or the NINDS representative will collect all copies of the report. The Open Session report will focus on study participant accrual and demographics, data completeness, and other study performance measures, any new information (on the intervention or disease/disorder) that may affect the outcome of the trial, and a list of publications or presentations. All data in the Open Session report will be presented in the aggregate, i.e., not by treatment assignment. The Closed Session report will divide study participants according to cumulative data or coded treatment assignment (e.g., Treatments A vs. B), comparing participant demographics and baseline characteristics, rates of and reasons for treatment discontinuation and loss to follow-up, rates of adverse safety events and, if an interim efficacy analysis is scheduled, rates of efficacy outcomes (depending on the DSMB operating procedures).

Typically, the principal study investigator will have prepared a report addressing specific concerns he or she anticipates the DSMB will have regarding the conduct of the study. This report should be sent to the NINDS DSMB Liaison for distribution to the DSMB along with the Open Session report. Likewise, the independent statistician's report for the Closed Session will usually contain his or her assessment of the progress of the trial, including recommendations on whether it should be terminated or modified. Interim data reports will generally include the following types of information, although only the Closed Session data reports will include comparisons by treatment group. If the randomization is stratified (e.g., by age), these tables and figures are presented by strata:

A summary of monthly accrual and cumulative accrual, overall and by clinical center, compared to targets.
A summary of baseline characteristics, overall and by treatment group.
A summary of the completeness and quality of data collection forms.
A summary of the status of enrolled participants, overall and by treatment group. (Study status includes whether the participant is on study or off study. For participants who are on study, there should be an indication as to whether they are on study treatment or off treatment. For participants who are off study, the reason should be indicated (i.e., completed study, died, refused further participation, lost-to-follow up, or other).
Summaries of participants off treatment, including a listing by participant ID number of those who have permanently discontinued study treatment and summaries (overall and by treatment group) of the reasons for going off treatment, the proportion of participants off treatment prior to reaching the study outcome, and the proportion of participants going off treatment each study month.
Assessments of whether the clinical centers have followed eligibility criteria and other protocol requirements.
An assessment (e.g., based on pill counts or diaries) of participant adherence to the treatment regimen, overall and by treatment group.
A summary of outcome rates by treatment group, if an interim efficacy analysis is scheduled.
A listing of individual serious adverse events (SAEs) by participant ID number and a table of event-specific cumulative rates, overall and by treatment group.
A listing of adverse events (AEs) by treatment group and body system.
A listing of protocol violations, if any.

View an outline for the DSMB Report (pdf, 312 KB) ( pdf, 305 kb )

3.8 Communication of DSMB Recommendations

At the conclusion of each DSMB meeting, the DSMB will provide a verbal report to the principal study investigator indicating areas of concern regarding performance and safety. The DSMB must not communicate any information that could lead to the unmasking of investigators or suggest interim treatment-specific results. Soon thereafter, the DSMB Chair will provide meeting minutes, including the DSMB’s recommendations to the Director of the NINDS Division of Clinical Research , through the NINDS DSMB Liaison. The NINDS DCR Director will determine if the NINDS concurs with the DSMB’s recommendations. The NINDS DCR Director or designee will communicate concurrence or not with the study PI. The NINDS DSMB Liaison will provide the DSMB minutes and recommendations to the study PI, along with a memorandum documenting: (a) the date of the review; (b) that all relevant interim safety and efficacy data were reviewed; (c) recommendations concerning the study execution or modifications to the study protocol; and (d) the anticipated date of the next review. The PI will promptly forward a copy of this memorandum to each participating study investigator for submission to their local IRBs, pursuant to the NIH 's Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-Supported Multicenter Clinical Trials (see NOT-99-107 ).

If the DSMB recommends an amendment to the protocol, it must be approved prior to implementation by the NINDS DCR Director, the IRBs and, for IND or IDE studies, the FDA. NINDS concurrence is required because some decisions may have significant programmatic implications. For example, a decision to extend the duration of a trial or increase the sample size has implications for the NINDS budget.

If as a result of interim data monitoring the DSMB determines that a trial: (a) has answered the primary study question i.e., crossing an efficacy or futility threshold (evidence of efficacy, evidence of lack of efficacy, or futility); (b) cannot recruit participants within a reasonable timeframe (as determined by the NINDS ); (c) is not being conducted according to high scientific or ethical standards; or (d) poses an unreasonable or unnecessary risk to study participants, the DSMB will recommend to the NINDS DSMB Liaison that the study protocol be amended, temporarily suspended, or terminated, as appropriate. If the NINDS DCR Director concurs, this recommendation will be conveyed to and discussed with the PI before any definitive action is taken. It will be important to ensure that the PI understands the DSMB's rationale. In addition, prior to a public announcement of a trial's early termination, a plan should be developed, reviewed by the DSMB and NINDS, and implemented for notifying the study investigators, the IRBs and the study participants. It is important that this communication emphasize that no urgent action is required to ensure the safety of the research subjects still under follow-up, if that is indeed the case. When a study is conducted under an IND or IDE, the FDA and the involved biopharmaceutical companies or device manufacturers must also be notified. Also, since a decision to modify or terminate a trial may influence the conduct of another, similar clinical trial, the NINDS may arrange to debrief that trial's study investigators or its DSMB in advance of the public announcement. The DSMB and PI/study staff should not discuss the study or its progress outside the DSMB scheduled meetings and not without the NINDS DSMB liaison. The NINDS DSMB liaison will serve as a conduit for all correspondence between the DSMB and the PI or study staff.

The DSMB and PI/study staff should not discuss the study or its progress outside the DSMB scheduled meetings and not without the NINDS DSMB liaison. The NINDS DSMB liaison will serve as a conduit for all correspondence between the DSMB and the PI or study staff.

3.9 Communications from Study Investigators

For clinical trials funded in whole or in part by the NINDS and involving an IND or an IDE (regardless of who the official sponsor is), a participating study investigator is obligated to inform the NINDS of any significant communication from the FDA concerning the trial, including warning letters, investigator disqualification notices, clinical holds, etc., within 72 hours of first learning of this FDA communication. Formal notification should be made in writing, but initial notification may be done by telephone if a written notice would delay the notification. It should include a statement of the action taken or contemplated and the assistance needed to resolve the situation. This policy is detailed in the Notice to NIH Grantees/Contractors Regarding Letters or Notices from the Food and Drug Administration (FDA) (see NOT-OD-00-053 ). The NINDS will bring the matter to the attention of the DSMB.

Resources and Tools

Data Safety Monitoring

NIH Policy Concerning Data and Safety Monitoring
Further Guidance on Data and Safety Monitoring for Phase I and II Trials
Guidance on Reporting Adverse Events to IRBs for NIH-supported Multicenter Clinical Trials
Regarding Letters or Notices from the Food and Drug Administration (FDA)

Certificate of Confidentiality (CoC)

NIH Announces Major Policy Changes for Certificates of Confidentiality (CoC)
NINDS CoC Website
NIH CoC website

Human Subject Protection

Responsible Conduct of Research

Conflict of Interest

Conflict of Interest web site

Race and Ethnicity

NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research

Grant Applications

PHS 398 Requirements

Seeking Patient Care?
Clinical Research
Clinical Research Operations & Regulatory Support (CRORS)

Clinical Research Monitoring

The purpose of clinical trial monitoring is to verify:

The rights and well-being of human subjects are protected.
The reported trial data are accurate, complete, and verifiable from source documents.
The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements such as the FDA, state laws, and University of Miami policies and procedures.

Monitoring Program

CRORS provides monitoring for UMMSoM investigator-initiated FDA-regulated (IND/IDE) clinical trials. CRORS may also provide monitoring services for IND/IDE exempt interventional drug or device studies as requested by a department or investigator and as workload allows.

CRORS should be contacted by the Sponsor-Investigator/ Principal Investigator / study team prior to IRB/FDA submission. During the initial consultation, CRORS will discuss the study protocol with the Sponsor-Investigator in order to develop a risk-based monitoring plan and also determine the fee to be charged for the monitoring services provided.

Risk Based Monitoring – A risk-based approach will be taken for all studies monitored by CRORS. For each study, the risk level will be assessed. Risk factors such as objective(s), purpose, design, complexity, blinding, participant population, number of trial participants, investigational product (IP), current knowledge of the IP safety profile and endpoint will be assessed. According to the determined level of risk, an individualized monitoring plan will be created for each study.

During the monitoring process, CRORS will assist the Sponsor-Investigator by:

Review of participant informed consent document and process
Review of subject eligibility for the trial
Review of safety i.e. adverse event reporting
Review of compliance with the protocol, regulations and institutional policies
Targeted review (based on the monitoring plan) of the accuracy, completeness and consistency of reported trial data against the source records and other trial-related records and whether these were reported in a timely manner
Ensuring that corrections, additions or deletions to case report forms (CRFs) are made as appropriate, dated, explained (if necessary).
Providing customized training to the study team based on any issues found during the monitoring visit
Confirming that the investigator is maintaining the essential records
Review of investigational product accountability
Reporting what was reviewed, significant findings, conclusions, actions required to the Principal-Investigator and/or Sponsor-Investigator
Follow-up with study team to resolve issues and action items.

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Medical Monitoring for Drugs and Biologics

Foundational course covering the essential components of medical monitoring.

About this Course

This course prepares medically trained individuals to become new medical monitors and enhances the knowledge of current medical monitors. Medical monitors participate as team members in clinical trials and have a key role in U.S. Food and Drug Administration-regulated research of drugs and biologics. The course describes the advice and input that medical monitors provide to sites and sponsors. It details their role in working with investigators to assess adverse events under 21 CFR 312. It also reviews the role monitors play in safety reporting to regulatory agencies and Institutional Review Boards. Lastly, the course provides learners with an overview of drug safety and pharmacovigilance.

Note: The course provides foundational role-based training for clinical research professionals. The course covers information that expands beyond but is directly connected to Human Subjects Research (HSR) and Good Clinical Practice (GCP) courses. Learners should have completed these basic courses prior to taking this course.

Course Preview:

Language Availability: English

Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Drug Safety Officers, Faculty, Medical Monitors, Principal Investigators, Research Administrators, Researchers, Sponsors, Students

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations Independent Learner Price: $99 per person

Course Content

Introduction to Medical Monitoring

This introductory module outlines the various roles of medical monitors in clinical research. It provides an overview of the stepwise drug development process and details the relationships among internal and external stakeholders involved in clinical research. This module further gives an initial survey of the multifaceted area of drug safety and the critical role that the medical monitor plays in ensuring the protection of human subjects.

Recommended Use: Required ID (Language): 20765 (English) Author(s): Richard Paul, MD - Drug Development Associates, LLC and Capital Health Inc.

" role="button"> Providing Advice and Input to Sponsors and Sites

This module covers how medical monitors use their scientific and therapeutic backgrounds to monitor a clinical trial, from informing the protocol's design to reviewing adverse events experienced by subjects during the study. It explores the common study-related documents medical monitors review and how they provide advice and input to sponsors and sites. The module also outlines the core elements of the medical monitoring plan.

Recommended Use: Required ID (Language): 20766 (English) Author(s): Richard Paul, MD - Drug Development Associates, LLC and Capital Health Inc.

" role="button"> Assessing Adverse Events (AEs) and Serious Adverse Events (SAEs)

Medical monitors play a key role in adverse event (AE) and serious adverse event (SAE) reporting. They provide the medical assessment of relatedness and expectedness that informs claims of causality. This module reviews AE and SAE reporting criteria and discusses the medical monitor’s role in safety oversight. It also describes how the medical monitor works with other safety team members to assess AEs and SAEs.

Recommended Use: Required ID (Language): 20767 (English) Author(s): Richard Paul, MD - Drug Development Associates, LLC and Capital Health Inc.

" role="button"> Safety Reporting to Regulatory Agencies and Institutional Review Boards (IRBs)

This module extends the analysis from prior modules to describe how different federal agencies, such as the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP), have different reporting requirements.

Recommended Use: Required ID (Language): 20768 (English) Author(s): Richard Paul, MD - Drug Development Associates, LLC and Capital Health Inc.

" role="button"> The Basics of Drug Safety and Pharmacovigilance

This module provides an overview of drug safety and pharmacovigilance (PV) issues relevant to medical monitors who engage with clinical drug development and safety teams. The module explains essential safety surveillance concepts and fundamental signal detection and risk mitigation steps. It further reviews U.S. Food and Drug Administration (FDA) guidance on assessing and reporting safety issues and best practices for analyzing and reporting safety data.

Recommended Use: Required ID (Language): 20769 (English) Author(s): Richard Paul, MD - Drug Development Associates, LLC and Capital Health Inc.

Who should take the Medical Monitoring for Drugs and Biologics course?

The course can be used as foundational role-based instruction for new and aspiring medical monitors needing training for safety oversight of clinical research. It can also be useful for organizations needing onboarding training for new medical monitors. The intended audience includes new medical monitors, principal investigators, faculty and postdocs, students, clinical research coordinators, clinical research associates, and research administrators who work in academia, government, industry, and contract research organizations.

How does the Medical Monitoring for Drugs and Biologics course complement other CITI Program courses?

Medical Monitoring for Drugs and Biologics complements CITI Program’s other courses covering clinical research stakeholders involved in safety oversight, including the Biomedical Principal Investigator (PI) course and the Clinical Research Coordinator series. The course covers information that expands beyond but is directly connected to Human Subjects Research (HSR) and Good Clinical Practice (GCP) courses. Learners should have completed their HSR and GCP basic courses prior to taking this course.

" role="button"> How long will the course take a learner to complete?

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. However, they can complete them at their own pace. The entire course can be completed in about three hours.

" role="button"> Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

" role="button"> What are the required modules for learner groups?

This course is designed to be completed sequentially through its five modules (we recommend they are set as “required”).

Required modules:

Providing Advice and Input to Sponsors and Sites
Assessing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety Reporting to Regulatory Agencies and Institutional Review Boards (IRBs)
The Basics of Drug Safety and Pharmacovigilance

What are the advantages of CITI Program's Medical Monitoring for Drugs and Biologics?

This course provides role-specific, peer-reviewed training written by an expert medical monitor. Along with CITI Program's advantages, including our experience, customization options, cost-effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for medical monitoring training.

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Guidelines for Developing a Data and Safety Monitoring Plan

Introduction.

The National Institute on Drug Abuse (NIDA), to assist grantees conducting or planning to conduct clinical trials, has developed these guidelines for data and safety monitoring (DSM) plans, in accordance with NIH requirements. The purpose of the DSM plan is to ensure the safety of participants in clinical trials and the validity of trial results.

Grant applicants must submit a general description of the initial DSM plan as part of the research grant application. The Scientific Review Group will review the DSM plan and any comments or concerns will be included in the summary statement. A detailed DSM plan must be submitted to and approved by NIDA before the trial begins. The responsibility for compliance with the DSM plan rests with the grant recipient.

These guidelines do not take the place of Institutional Review Board (IRB) guidelines, Food and Drug Administration (FDA) requirements, or special NIH guidelines, e.g., NIH Guidelines for Research Involving Recombinant DNA Molecules. Specifically, Phase I and II gene transfer trials must comply with additional requirements imposed by NIH Guidelines, e.g., reporting of adverse events to the Office of Science Policy.

In June of 1998, NIH issued a policy stating that “each Institute or Center (IC) in NIH should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or conducted clinical trials.” According to this policy, data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III); etc. It includes all types of intervention studies, whether medication or non-medication (e.g., behavioral, prevention, diagnostic) trials. Monitoring should be commensurate with the study risks. This policy provides each IC with the flexibility to implement the requirement for data and safety monitoring as appropriate for its clinical research activities. ( https://grants.nih.gov/grants/guide/notice-files/not98-084.html )

Further guidance to this policy ( https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html ), released in June of 2000, stated that beginning with the October 2000 receipt date, investigators must submit a monitoring plan for Phase I and Phase II clinical trials to the IC before the trial begins. Also, a general description of data and safety monitoring plans must be included as part of the competing grant application.

Trials that require a DSM Plan/Board

Figure 1 shows a decision tree to determine the need of a DSM plan and/or a DSM Board. According to the NIH DSM policies, DSM plans are required for all clinical trials of all phases for which grant support is sought. For the purpose of these guidelines, a clinical trial is a prospective study to test the effect of a biomedical or behavioral intervention in human subjects. It includes medications, herbal/nutritional supplements, physical interventions, behavioral interventions, prevention trials, and/or diagnostic tools that affect the outcome of the study participants.

The requirement of a DSM plan covers career and training awards in which the trainee has direct responsibility for conducting a clinical trial or in which award funds directly support a clinical trial.

Grants that include multiple clinical trials must submit a DSM plan to NIDA prior to initiation of each new trial. Initial funding of a grant and continuation of funding will be contingent on the Institute’s acceptance of the DSM plans.

In addition to the DSM plan, a Data and Safety Monitoring Board (DSMB) is generally required for Phase III clinical trials. For earlier medication trials (Phase I or II) and some behavioral clinical trials, a DSMB may be appropriate if the study has multiple clinical sites, is blinded, is First-in-Man, tests a high-risk intervention, or is conducted in vulnerable populations. Generally, Phase III trials involve larger numbers of subjects, but size is not a specific criterion for this designation.

The purpose of the DSMB is to monitor the safety of the interventions and the validity and integrity of the data from clinical trials that require a DSMB. The decision to establish a DSMB is commensurate with the level of risk and/or the number of treatment sites participating in the study. A DSMB may be required by the grantee’s institution, but the ultimate decision rests with the sponsoring Institute. In conducting its reviews and making recommendations, the DSMB works to assure that the safety of study subjects is protected while the scientific goals of the study are being met. In monitoring the data and safety of the trial, The DSMB may recommend continuation of the trial, modifications to the trial, or termination of the trial in the event of overwhelmingly significant efficacy difference between groups or unacceptable adverse events.

Adverse events are defined as any untoward medical occurrence that may present itself during treatment or administration of an intervention, and which may or may not have a causal relationship with the treatment. Serious adverse events are defined as any medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; creates persistent or significant disability/incapacity, or a congenital anomaly/birth defects. Adverse events and serious adverse events may occur in medication and non-medication trials. In non-medication trials, for example, AEs may include suicidal ideation/attempts, drug or alcohol overdose/withdrawal, etc. Guidance about definitions and reporting of AEs and SAEs can be obtained at:

https://grants.nih.gov/grants/guide/notice-files/not99-107.html
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ CDER/ContactCDER/default.htm
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/default.htm
https://www.fda.gov/Safety/MedWatch/default.htm

Figure 1. DSM Plan/Board Decision Tree

Elements of a DSM Plan

The overall elements of the DSM plan may vary depending on the potential risks, complexity, and nature of the trial. They also depend on whether it is an initial or a detailed DSM plan.

Initial DSM plan

Research grant applications that involve clinical trials must include a general description of the DSM plan. The PHS 398 application instruction indicates where to place this description and what to include. The initial DSM plan should include a brief description of data management methods, collection and reporting of Adverse Events (AE) and Serious Adverse Events (SAE), medical safety measures, communication plan with IRB/FDA/NIDA, interim analysis plans, and content and frequency of DSM reports to NIDA. The entity responsible for monitoring should be specified. The Scientific Review Group reviews the initial DSM plan and may provide comments or concerns, which are included in the summary statement. Appendix B, C, and D have samples of initial DSM plans for pharmacotherapy, behavioral, and prevention trials, respectively.

Detailed DSM plan

A detailed DSM plan must be submitted to and approved by NIDA before starting a new trial. Appendix A has a checklist of the basic elements of a detailed DSM plan. The responsibility for compliance with the DSM plan rests with the grant recipient. Notice of Grant Awards (NGA) will include terms to put into effect NIH DSM policies.

The detailed DSM plan should include:

Summary of the protocol

Brief description of the protocol (Study design) and table for schedule of events
Primary and secondary objectives and outcome measures
Inclusion/exclusion criteria
Power calculation and sample size

Trial Management

List of participating enrolling clinics or data collection centers
Planned enrollment timetable (graph showing time vs. projected enrollment) (Enrollment: participants who are randomized and received treatment/intervention in the trial)
Target population distribution (e.g, gender, minorities, etc)

Data Management and Analysis

Data acquisition and transmission
Data entry methods
Data security and plan for protecting confidentiality
Data analysis plan

Quality Assurance

Procedures in place to ensure the validity and integrity of the data
Procedures to guarantee the accuracy and completeness of the data, during data collection, entry, transmission, and analysis.

Regulatory Issues

Medication trials: to the IRB, NIDA, and, as applicable to the FDA.
Non-medication trials: to the IRB and NIDA.
Reporting of IRB actions to NIDA
Report of changes or amendments to the protocol (Changes made to protocol must be pre-approved by NIDA)

Trial Safety

Potential risks and benefits for participants
Risk mitigation plan (Management of SAEs or other study risks)
Trial stopping rules
Process of AE/SAE collection, assessing by PI and/or medical monitor and reporting
AE/SAE follow up plan

Trial Efficacy

Plans for Interim Analysis of efficacy data (if applicable)

DSM Plan Administration

Persons responsible for monitoring the trial
Disclosure of any conflict of interest
How often are the data reviewed in the course of the trial?
Brief description of the trial and progress
Enrollment update and baseline sociodemographic characteristics
Retention and disposition of study participants (active, completed, and terminated/withdrawn)
Regulatory Issues (amendment, deviations, IRB report, Q.A issues)
AEs and SAEs listings
Efficacy (if applicable)

If applicable, DSM Board Plan

Members and affiliation
Conflict of interest
Frequency of meetings
Protection of confidentiality
Monitoring activities (initial and ongoing study review)
Communication plan to IRB, NIDA, and FDA (if applicable)

Review of DSM Plans by NIDA Staff

The Project Officer assigned to the grant will review the DSM plan prior to starting the trial. The review focuses on the quality of the process that the investigator is planning to have in place to ensure the safety of the participants and obtain reliable results. The Project Officer’s review is based on the adequacy with which the plan covers the essential elements outlined above. According to NIH policy, the detailed monitoring plan must be included as part of the protocol and submitted to the local IRB and reviewed and approved by the funding Institute and Center (IC) before the trial begins. The responsibility for compliance with the DSM plan rests with the grant recipient. Appendix E shows the review process for DSM related actions.

For questions or comments please contact:

Ivan D. Montoya, M.D., M.P.H. Deputy Director, Division of Therapeutics and Medical Consequences 6001 Executive Blvd. Bethesda, MD 20892-9551 Phone: (301) 827-5936 Fax: (301) 443-2599 e-mail: [email protected]

Appendix E. – DSM Plan Review Process

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Template
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PDF Tool Summary Sheet: Clinical Monitoring Plan Template
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Guidelines for Developing a Data and Safety Monitoring Plan
The National Institute on Drug Abuse (NIDA), to assist grantees conducting or planning to conduct clinical trials, has developed these guidelines for data and safety monitoring (DSM) plans, in accordance with NIH requirements. The purpose of the DSM plan is to ensure the safety of participants in clinical trials and the validity of trial results.

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Tip #1: Long Before the Monitoring Visit, Keep your Delegation of Authority Log & Protocol Trainings Air-Tight

Tip #2: Cross Off Your Site Monitor’s Action Items From the Last Monitoring Visit

Tip #3: Store your regulatory binders in one neat place

Tip #4: Digitize Your Common Documents in Your Regulatory Binders

Tip #5: Track All of The Document Expiration Dates In Your Regulatory Binders

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Data and Safety Monitoring Plan Writing Guidance

Introduction

Determining the Appropriate Level of Monitoring

Required Elements of a Data and Safety Monitoring Plan

What is the purpose of clinical trial monitoring?

Victoria Yorke-Edwards

Rebecca Haydock

Katie Biggs

Gosala Gopalakrishnan

Lydia O’Sullivan

Estelle Payerne

Kerenza Hood

Garry Meakin

Supplementary Information

Conclusions

Acknowledgements

Abbreviations

Authors’ contributions