Regulatory Binder
Essential documents.
The ICH GCP Guidelines define Essential Documents as those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of data produced. These documents serve to demonstrate compliance with standards of Good Clinical Practice and with all applicable regulatory requirements. Filing essential documents in a timely manner can greatly assist in the successful management of a clinical trial.
The Regulatory Binder is often the first document reviewed during audits and inspections. Not all the essential documents are available at the start of the study. Documents can be grouped into those that are generated before study initiation, those that are generated during trial conduct and those that are generated after study completion.
Not all documents have to be filed in one single binder. The Regulatory Binder may sometimes consist of several binders that are stored in the same or different locations. It is important to know where all these documents are located to be able to pull them out when needed in a timely manner. The Regulatory Binder is referred to synonymously as the Study Files, Investigator Files or Investigator Binder.
Organizing Your Regulatory Binder
Instructions: Create tabs for each section listed below and place the appropriate documents in each corresponding section in a binder. Be sure to label the outside of the binder (cover and spine) with the protocol number, PI name, and study site. Use multiple binders or master binders to maintain documentation if needed.
Anytime information is kept in a master binder, place a note to file (in the section of the Binder) referencing the location of the separate binder.
1. Site Visit (Monitoring) Log
This provides documentation at the site that the study was monitored and the frequency of monitoring. The monitor and designated site staff both sign the log to verify the date the monitor was present. For consecutive days, each day is entered separately.
2. Delegation of Authority (Responsibilities) Log
This log documents responsibilites assigned to research team members and their dates of involvement in the project. It helps ensure the appropriate delegation of study related tasks.
3. Site Personnel Signature Log
This documents the names and provides handwriting samples of all personnel involved in the conduct of the study
4. Study Personnel Education
All personnel involved in research with human subjects are required to complete the following:
Human Subject Protection Training HIPAA Training
When adding personnel to the study, they must complete all of the above and their addition must be IRB approved prior to participating in the study.
4.1 Training Log
This is a record of training provided, e.g. protocol training or other study-specific training of staff. This should include a site initiation visit (SIV) attendance log.
5. CVs/Financial Disclosures/Investigator Statements
This section should include:
Curricula Vitae, licenses, and certifications for all study staff Disclosure information, including each Study Specific Disclosure form submitted to the IRB. FDA Form 1572 (if applicable): Date and sign all versions FDA Form 1571 (if applicable): for Investigator initiated INDs Signed investigator agreement (if applicable): for device studies
6. Public Registration of Research Studies (PRS) (If applicable)
All research studies that are applicable clinical trial must be registered at www.clinicaltrials.gov as per the International Committee of Medical Journal Editors (ICMJE), the FDA Amendment Act of 2007, and institutional policy.
Contact the Georgetown PRS Administrator, Patricia Mazar at [email protected] to set up a PRS user account.
Note: For commercially funded, multi-center studies, public registration is typically handled by the study sponsor or CRO.
Place the registration receipt in this section for initial registration and for any updates.
7. Screening/Enrollment Log
This section should include a log of subjects who were screened (and reason for screen failure) and enrolled. Some studies allow for re-screening of subjects.
8. Subject Visit Tracking Log
This log tracks all enrolled subjects’ visits, reason for early termination and keeps visits scheduled as per protocol.
9. Subject Identification Code List
This is a confidential list of the names of all the subjects that provides a link between their identity and their study code to allow the Investigator to reveal the identity of any subject, if necessary.
10. Consent Forms
This section should include consent form document(s) (all IRB approved and stamped versions) stored in reverse chronological order with the current approved version first.
Place most currently approved consent form in a plastic sleeve
Note: Any changes to the consent form must be submitted to and approved by the IRB prior to use. Submit consent amendments through eRIC .
Guidance for consent of Non-English speaking subjects can be found here .
10.1 HIPAA Forms
(Authorization, Waiver, and/or Research Preparation Purposes)
This section includes all IRB approved and stamped versions of any of the HIPAA forms (as applicable).
HIPAA regulatory information
11. Protocol
This section should include the protocol (and protocol signature page) and all amendments (and amendment signature page or pages), stored in reverse chronological order with the current approved version first.
Note: Any changes to the protocol must be submitted to and approved by the IRB prior to implementation. Submit amendments through eRIC .
12. IRB Federal Wide Assurance Letter
This section should contain the most current IRB assurance letter
13. IRB Approval(s) /Communication
This section should include copies of the original IRB application/submission, IRB approval letters (contingent and final approval), and all correspondence with the IRB (including emails).
It includes IRB Membership Rosters , Continuing Review Submissions, protocol modifications and DSMB reports and close-out (final study) reports.
Contact the IRB for a copy of any missing documents.
14. Investigational Product Information (as applicable)
Investigator’s Brochure (IB)
This section must include all versions of the IB (may be maintained separately with note in section explaining location of IB) and receipt forms.
Evidence of IRB submission and review of all versions must be maintained.
Package Insert
For FDA approved agents, file a copy of the package insert.
Device Manual
Fo device studies this section should have a device information sheet/manual.
15. Study Termination If your research study is being terminated or if the PI is leaving and the study will no longer be continued, inform the IRB through eRIC .
16. Protocol Deviations / Protocol Exceptions
This section should include correspondence relevant to the issue and copies of the documents stored in reverse chronological order with the most current documents first.
Please note that some Sponsor approved waivers may need to be approved by the IRB prior to implementation.
GU IRB Manual-Policy on Reporting Protocol Deviations
CAPA Template (Corrective Action and Prevention Plan)
17. Adverse Events and Unanticipated Problems
This section should include correspondence, copies and acknowledgements of reports for internal AEs and unanticipated problems reported to the IRB and Sponsor and regulatory authorities as applicable.
AE/SAE Log : Adverse events encompass both physical and psychological harms. They can occur in the context of medical, behavioral and social research.
Unanticipated Problem Log : Click here for examples of unanticipated problems that do not involve adverse events.
GU IRB Manual-Policy on Reporting Adverse Events and Unanticipated Problems
Submit reportable events through eRIC .
18. IND Safety Reports
This section should include correspondence (including IRB acknowledgement) and copies of Safety Reports for external AEs reported to the IRB.
19. Advertising/Educational Materials (if applicable)
This section should include: Any IRB approved advertisements, recruitment flyers, written educational, or other materials provided to study participants, stored in reverse chronological order with the most current documents first.
Note: For marketing materials used to recruit through mass media (e.g. newspaper, TV, radio, some internet postings, & etc.) you must contact the Georgetown University Medical Center Communications Office to ensure logo/branding is appropriate.
20. Sample Tracking and Shipping (if applicable)
This section should include a master log that allows tracking of research specimen sample collection, shipment (or transport), and storage, and packing and shipping training certification (from Saf-T-Pak or other approved equivalent program).
Shippers or receipts can be placed in this section or in individual subject files.
Note: All biological materials must be handled, stored, and shipped in compliance with FAA and IATA regulations as well as GUMC policies on hazardous materials.
21. Temperature Logs for Refrigerator/Freezer
Temperature logs document compliance with Protocol /Study Procedures requirements and GCP.
22. Investigational/Test Article
This section includes:
Shipment records (usually requires site signature of receipt and Sponsor notification of receipt)
Site Accountability Records (inventory of overall supply of drug/device, promps reordering of supply)
Subject Drug Accountability Records / Device Log (documents the date and quantity of drug/device dispensed to subject and return of drug/device from subject
Blind Break Instructions (instructions for revealing the identity of the treatment, if blinded)
Interactive Voice Response System Instructions (IVRS), if applicable
**Maintain drug accountability in the Research Pharmacy over the course of the study; at the trial completion file all records here.
23. Local Lab Certificates/Reference Ranges
For every lab listed on FDA Form 1572, place a copy of (maintain current certifications for duration of study):
Lab certificate(s) and reference ranges (for the duration of study) Lab director’s CV
Note: The above is not required for research labs that perform testing where results will not be shared with subjects or their treatment providers.
For studies that use MedStar/Georgetown University Hospital Laboratories, click HERE
24. Correspondence
Please document and maintain all relevant, significant communication from the sponsor, the CRO or monitor in this section. Study related Newsletters may be placed in this section.
25. Blank Set of Case Report Forms
26. Notes To File (NTF)
These may include site generated and/or sponsor generated notes to file. Sponsor generated NTF may be global or site specific.
27. Other Documents
Other necessary approvals (e.g. Radiation Safety Committee)
Place other important study documents in this section. This can include: Certificates of Confidentiality, literature or publications, correspondence from the FDA or NIH, and other general correspondence.
28. Additional Tools
We’d like to hear from you. If you have suggestions, comments, or questions about this regulatory binder, please contact Bronwyn Murray at [email protected] or at 202-687-1350.
How to Prepare a Research Binder for Model UN
The best delegates are usually those with the most information. It is this knowledge, strategically used, that allows them to be key diplomats during a Model United Nations committee session. At those conferences which do not allow electronic devices or internet use, access to information becomes even more critical. To excel in such cases delegates need research binders, to be able to organize information effectively and reach it quickly.
Researching countries, committees, and topics for the conference is the most important thing you will need to prepare. As you have seen, there is so much information available, it can be overwhelming. As a delegate, you will have to learn your country, committee assignment, rules of procedure, and how to write Model UN position papers and resolutions. If all of this data does not get organized into a research binder, you will not have the information you need when you need it. While most things are electronic in nature now, for conferences that do not allow electronics, nothing will be better than having a physical research binder to take with you. Besides, electronic devices will most likely not be allowed informal committee sessions, so it will be best to have all of the information in print form.
This article will help give you an idea of how to create a research binder. We will give you a breakdown of what needs to go in it and give some resources where you can find some of the information. Also, for those who can bring in computers or electronics, this guide can give you useful ideas on how to sort your folders and files.
1) Study Guide/Background Guide Have a short section of United Nations history here, but not much. Just some major dates and conventions will be useful. Check our articles on UN history and The UN Today for some general information.
You will want to have some good background information about the committees they are representing. What is its mandate? How long has it been around? What are its major accomplishments? Knowing the ins and outs of their committee will ensure that they can focus their energy on the topics at hand.
2) Country Information For a good idea of how you can prepare research for your country, check out on how to research for Model UN .
As the guide says, don’t go too far back with your research. What happened in your country’s past is important, but will a civil war in the 1950’s effect the outcome of negotiations in your committee. Remember, every country has history, but the UN focuses on the here and now. Your committees will be focused on modern issues that affect the world today, so focus on what your country is doing now and in its very recent past.
3) Previous Resolutions/Voting History You need to research how your country has responded to issues within the UN, including resolutions it has sponsored. At the UN Member States , On the Record webpage, you can find the information you need. You can search your country’s sponsored resolutions, general debate statements, and activities within different committees. When you know the topics that will be discussed in committee, it would be a good idea to narrow your search down to see how your country has responded to those issues recently. Print these resolutions out and have them in the binder for reference.
4) Treaties, Conventions, and Think Tank Papers The United Nations Treaty Collection web-page will help you find out which treaties your country is a signatory to. If the topics for your committee concern specific treaties, find them print them out. If your country is a signatory on the treaty then know why. If it is not, then there is probably a specific reason for that. Use the treaty collection page as a resource to begin research.
A list of UN declarations and conventions can be found here . The database can be searched by year or by subject.
Be sure to look for information relevant to your country and committee at some reputable Think Tanks. Some of the top Think Tanks are listed here . Be sure to gather as much relevant information you can that will help you prevail in MUN negotiations.
5) Countries in Relevant Blocks You will need allies at the conference, but you want to make sure it is with countries your country would usually be allied with. For example, if you represent Ukraine, there is little chance you will be co-sponsoring a resolution with Russia about the need for global cooperation.
Refer to our article that outlines regional organizations. Is your country contained within one of these larger blocks? This is a good place to start looking for allies. What other countries share similar issues with yours? Find them and work with them. If you represent a smaller country, don’t think you won’t be able to form a large voting block to be taken seriously. Have this information in your binder and ready to present during caucuses.
6) Committee Background You will want to have a complete understanding of what your committee’s mandate and purpose is. Find your committee here on the UN’s website to get started. You will want the following:
- Committee mandate
- Major accomplishments
- Current involvement
- Your country’s involvement with the committee
7) Your Ideas Have a realistic idea of what your positions will be when you get to the conference. You will know ahead of time all of the topics that will be discussed. You will probably have written a position paper for your country to send to the committee before the conference, so keep the research you used for the paper and put it in the binder. You will have your research binder and will know your positions. You will know who you need to get on your side as allies. Make a list of the most important things for your country. You know what positions you will generally take, so be ready to defend them.
8)Rules of Procedure/Points and Motions After watching this video and checking out our points and motions page , you will have an idea of what to expect. The UN Association of the United States has a page dedicated to rules of procedure and a chart that you should print out and put in the binder for reference.
How to Include Your Own Notes
Many conferences do not allow delegates to bring pre-written resolutions. This could create an unfair advantage to some delegations, especially newer ones. That does not mean that you can’t plan well for what they “think” they may write about. Based off of the positions that will be up for debate and the research the students have completed, here is a list of things they should have in their “ideas” section of the binder.
Main allies Know ahead of time countries who share similar positions Be ready with facts and information for them
Number and Facts Have your counties demographics and economic numbers If the committee is going to discuss HIV/AIDs then have your country’s data about that separate and ready to use Specific facts from reputable sources are hard to argue against
To get statistics on your country’s demographics, economics, and other vital information, you can go to the UN member list here . The CIA World Factbook is also a good resource. Having factual numbers ready to present during formal sessions and unmoderated caucuses will be powerful during debates. It is hard to argue with facts.
Current global situations MUN is a fluid environment and adapts to what is happening in the world Use this as talking points in a moderated and unmoderated debate
A one-inch three-ring binder should be sufficient for this information. Make sure to get tabs for each section. Every delegate would benefit from having their own binder. Remember, Model UN is an activity designed primarily to help students gain skills they will use to further their academic careers and beyond. Research skills are a large part of that. By making this research binder, you are doing more than just preparing for a conference. You are preparing for a lifetime of the organization.
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Crafting the Perfect MUN Research Binder
Riaan Rao • 2023-08-03
Take a quick look at some tips for the prefect MUN research binder!
Preparing in-depth research is crucial for success at Model UN conferences. A well-organised research binder can help you access key facts and arguments quickly during debates. Here are some essential tips to keep in mind:
C OUNTRY I NFORMATION
Gather details about your country's position on relevant issues, UN voting history, and current foreign policy goals. Find resolutions your country has sponsored and statements it has made within committees. Update yourself on any recent political developments that affect your stances.
A LLIES AND R EGIONAL B LOCS
Identify allies that share similar priorities and positions. Look into regional organisations your country belongs to for potential coalition partners. Having a strong voting bloc can amplify your country's voice in committee.
C OMMITTEE B ACKGROUND
Familiarise yourself with your committee's role, mandate, historical accomplishments, and current activities. Understand your country's past involvement to realistically frame your delegation's stances.
Collect relevant data, think tank reports, and treaty provisions related to topics under your committee's purview. Print out essential resolutions, conventions and treaties for quick referencing during debates.
Y OUR C OUNTRY ’ S P OSITION
Outline the key issues and priorities for your delegation based on your research. Note facts and statistics you want to cite during discussions. Keep track of potential compromise solutions.
R ULES OF P ROCEDURE
Include a printed guidelines sheet with key motions and points of order. Having this ready will help you navigate formal procedures smoothly.
L EAVE B LANK N OTES P AGES
The topics under discussion may evolve, so allocate sections for taking your own meeting notes and jotting down new ideas.
Organise materials using labelled dividers and a binder large enough to accommodate extra readings and position papers you compile.
A well-planned MUN research binder can speed up research and is useful for more than the information it contains. Good luck, and have a great MUN!
References:
https://www.wisemee.com/prepare-mun-research-binder/
https://bestdelegate.com/mun-research-made-easy-15-things-every-delegate-should-have-in-their-research-binder/
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Model UN Research
When researching for Model UN, you should think about five different types of research:
Country Profile
Topic background, past international action, country policy, possible solutions.
Your research across these five categories should all go in to your “Research Binder”, which you should put together to prepare for a conference. Read more about what to include in a research binder here!
To get started with research, its important to understand the country you’re representing- where it is, who lives there, who your allies are, what type of government your country has, and more. Together, the answers to these countries comprise your “Country Profile”. Here are some guiding questions to get you started:
What is your country’s official name? What region of the world is your country located in? How big is your country? (square miles) Who are your country’s neighbors? How would you describe your country’s physical features and climate?
Politics and Government
When was your country founded? What type of government does your country have? Who are some of your country’s leaders? How many people serve in your country’s military? Who are your country’s allies? Enemies? What is your country’s capital?
What is your country’s population? What is your country’s ethnic composition? What is your country’s official language? What other languages are spoken? What are some of the major cities?
How would you describe the quality of life in your country? What is your country’s total Gross Domestic Product? What are some of your country’s natural resources? What is your country’s currency? What are your country’s major imports and exports? What are your country’s biggest trading partners?
To find the answers to these questions and more, we recommend you use our Country Profile Map!
- Clearly define what the topic is.
- Identify the key terms related to the topic, and answer key questions about the topic such as “What causes this issue?”, “Who is impacted by this issue?”, and “Where is this issue most prevalent?”.
- Make sure you’re using credible sources of information to understand your topic- don’t just use Wikipedia, the news, or blogs!
Interested in how to write the Topic Background section in a Position Paper? Check out our article about it!
One of the most important things to understand when discussing any topic in Model UN is what the United Nations and international community has already done about the topic. You don’t want your solutions to be redundant, and you want to make sure you’re aware what the world already has, and hasn’t done. Past international action can come in the form of UN resolutions, international conventions and treaties, or actions by NGOs and international organizations. Here are some resources to help you find the past international actions related to your topic, or you can check out our article about using UN sources to research your topic!
Past UN Resolutions International Conventions and Treaties Reports of the Secretary General Reports of the Economic and Social Council
Plus, our NGO Guide details the work of over 100 NGOs over a broad range of issues, so you can see what Civil Society is doing about your topic already.
Interested in how to write the Past International Action section of your Position Paper? Check out our article about this section!
Once you have a decent understanding of the topic and your country, you take this knowledge together and learn what your “Country Policy” is on your topic. Your Country Policy is what your country thinks should be done, or not done, about the issue, and how this topic impacts your country. This means determining if your country is in favor of solutions that have been proposed or resolutions that have been passed, or if your country has been advocating at the UN for policies.
A good starting place to learn your country policy is to research what your country’s government, foreign ministry, or UN mission have said about the topic on their website. Use our Country Profile and Policy Map to check out these websites for your country! Other resources to use from the UN include the following:
Member States on the Record: Speeches at the United Nations Member State Votes on Resolutions Signature/Ratification Status for Each Country of Important Conventions and Treaties
The most important part of researching for a Model UN conference, and often the most forgotten, is to research Possible Solutions to help resolve the issue your committee is discussing. The solutions aren’t what your country wants to do for itself- that would never need to be discussed at the UN. Instead, you should consider what your country wants the United Nations to do about the issue worldwide. Feel free to use your own creativity to think of ideas, and find reasons why they would work that you can use in speeches, and later in your resolutions in committee.
All resolutions should be realistic, and can even build on past solutions the UN has tried- maybe you want to expand a program worldwide that was previously local. Maybe you think that a specific solution needs more support or funding. Feel free to include existing UN action in your solutions, but new and creative ideas are always welcome as well! Aside from the United Nations and Member States, other good places to look for solutions are in the existing work of NGOs ( check out our NGO Guide here ), through various Think Tanks worldwide, and in university publications.
Other Resources
Structure and publications of the united nations.
- United Nations Main Page
- UN Overview
- UN Treaties
- UN Research Guide
- UN Cyber Schoolbus
- Permanent Missions to the UN
- Universal Declaration of Human Rights
- Issues on the UN Agenda
- WWW Virtual Library: the United Nations
- UNA-USA’s MyDiplomat App
General Assembly Committees and Main UN Organs
- General Assembly
- First Committee: Disarmenent and International Security
- Second Committee: Economic and Financial
- Third Committee: Social, Humanitarian, and Cultural
- Fourth Committee: Special Political and Decolonization
- Sixth Committee: Legal
- Economic and Social Council
- Security Council
- Security Council Resolutions
- International Court of Justice
UN Specialized Agencies, Programs, and Funds
- UN Children’s Fund (UNICEF)
- UN Educational, Scientific and Cultural Organization (UNESCO)
- UN Development Programme (UNDP)
- UN Environment Programme (UNEP)
- UN High Commissioner for Human Rights
- UN High Commissioner for Refugees (UNHCR)
- UN Center for Regional Development
- UN Commission on International Trade Law
- UN Conference on Trade and Development (UNCTAD)
- UN Commission for Social Development
- UN Commission on Crime Prevention and Criminal Justice (CCPCJ)
- UN Commission on Narcotic Drugs
- UN Commission on Sustainable Development
- UN Commission on the Status of Women (CSW)
- UN Commission on Population and Development
- Food and Agricultural Organization (FAO)
- International Atomic Energy Agency (IAEA)
- International Civil Aviation Organization (ICAO)
- International Criminal Court (ICC)
- International Fund for Agricultural Development
- International Labor Organization (ILO)
- International Maritime Organization (IMO)
- International Monetary Fund (IMF)
- International Telecommunication Unit
- UN Industrial Development Organization (UNIDO)
- International Research and Training Institute for the Advancement of Women
- UN Center for Human Settlements
- UN Office on Drugs and Crime (UNODC)
- UN Information Center
- World Health Organization (WHO)
- World Intellectual Property Organization (WIPO)
- World Meteorological Organization
- World Trade Organization (WTO)
- UN Statistics Division
- Joint United Nations Programme on HIV/AIDS
Country Profile Links
General Research on Countries
- Check out our New Country Policy Profile and Policy Map
- CIA World Factbook
- US State Department Background Notes
- List of Governmental Websites
- List of International Governmental Organizations
- Foreign Governments Comprehensive Web Site Listings
- Library of Congress Country Studies
- The Lincoln Library
- The Electronic Embassy
- Country Watch
- The Economist Country Briefings
- Government and Legal Structure by Country
- BBC Country Profiles
- Group of 20
- World Bank Data and Statistics
- NGO Global Network
African Countries
- African Union (AU)
- African Development Bank
- The Economic Community of West African States
- The Economic Community of Central African States
- South African Development Community
- WWW Virtual Library: Africa
Asian & Middle Eastern Countries
- Asia-Pacific Economic Cooperation (APEC)
- Association of Southeast Asian Nations (ASEAN)
- Shanghai Cooperation Organization (SCO)
- League of Arab States
- Organization of the Islamic Conference (OIC)
- South Asian Association for Regional Cooperation (SAARC)
- WWW Virtual Library: Asia
European Countries
- European Union (EU)
- North Atlantic Treaty Organization (NATO)
- Organization for Security and Cooperation in Europe (OSCE)
- Council of Europe
- Western European Union
- Policies of the European Union
- WWW Virtual Library: European Union
North & South American Countries
- Organization of American States (OAS)
- North American Free Trade Agreement (NAFTA)
- South American Common Marke
- Economic Commission for Latin America and the Caribbean (ECLAC)
- Latin American Economic System
- Pan American Health Organization
- Small Islands Developing State Network
- Caribbean Community and Common Market
- Andean Community
- Council of Canadians
- WWW Virtual Library: Latin America and the Caribbean
United States of America
- The White House
- Library of Congress
- WWW Virtual Library: American Foreign Policy
Links by Topic Category
Peace and Security
- UN Peace & Security Page
- UN Disarmament Page
- Organization for the Prohibition of Chemical Weapons
- UN Institute for Disarmament Research
- Preparatory Commission for the Comprehensive Nuclear-Test-Ban Treaty Organization
- International Atomic Energy Agency
- Nuclear Threat Initiative
- UN Peacekeeping
- UNODC and Terrorism Prevention
- UN Terrorism Page
- Global Security
- Carnegie Endowment
- Crisis Group
- United Nations Department for Disarmament Affairs
- United Nations Institute for Disarmament Research
- US National Counterintelligence Executive
- US National Security Agency
- International Relations and Security Network
- UN Mine Action Service
- Adopt-a-Minefield
- International Campaign to Ban Landmines
- WWW Virtual Library: Peace and Security
Development: Economic and Environmental
- UN Development Page
- UN Development Programme
- World Trade Organization
- International Monetary Fund External Country Information
- World Bank External Country Information
- UN Conference on Trade and Development
- UN Global Issues
- Division for Sustainable Development
- International Labor Organization
- UN Industrial Development Organization
- High Representative for the Least Developed Countries, Landlocked Developing Countries, and Small Island Developing States
- Council for a Community of Democracies
- Debt AIDS Trade Africa (DATA)
- UN Environmental Programme
- UN Framework Convention on Climate Change
- UN Convention to Combat Desertification
- Ecolex- Environmental Law Information
- European Environmental Law Page
- Geneva Environment Network
- United Nations System- Wide Earth Watch
- World Resources Institute
- United Nations Framework Convention on Climate Change
- WWW Virtual Library: International Development
Development: Humanitarian and Health
- UN humanitarian affairs page
- UN Educational, Scientific, and Cultural Organization
- Global Fund to Fight AIDS, Tuberculosis and Malaria
- UN Division for the Advancement of Women
- UN International Training Institute for the Advancement of Women
- Americans for UNFPA – One Woman Can
- Child Rights Information Network
- Database on Research and Information on Children’s Rights
- Childwatch International Research Network
- Save the Children
- UN Children’s Fund
- Children in Conflict
- Women Watch
- United Nations Population Fund
- Population Action
- World Health Organization
- Global Health
- World Food Programme
- Food and Agricultural Organization
- International Committee of the Red Cross
- Doctors Without Borders
- UN High Commissioner on Refugees
- UN Office for the Coordination of Humanitarian Affairs
- UNICEF in Emergencies
- Federation of American Scientists
- WWW Virtual Library: Human Rights and Humanitarian Affairs
Human Rights
- UN Human Rights Page
- UN High Commissioner on Human Rights
- Human Rights Watch
- Amnesty International
- Freedom House
- Human Trafficking
- US Department of State Human Rights Reports
- Bayefsky List of UN Human Rights Treaties
- Project DIANA at Yale – Human Rights Documents
- Center for the Study of Human Rights
- Human Rights First
- Human Rights Internet
- International Human Rights Law Institute
- International League for Human Rights
- 50 th Anniversary of the Universal Declaration of Human Rights
- University of Minnesota Human Rights Library
International Law
- UN International Law Page
- International Criminal Court
- International Law Commission
- World Intellectual Property Organization
- World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights
- WWW Virtual Library: International Law
News Sources
- Google Scholar
- Google News
- Google News Alerts
- Financial Times
- International Herald Tribune
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Putting together a binder sounds time-consuming, but it takes less time and brain power to learn something that is organized well. When you’re reading different websites and books, the important facts are spread out across different sources.
The Regulatory Binder is referred to synonymously as the Study Files, Investigator Files or Investigator Binder. Organizing Your Regulatory Binder Instructions: Create tabs for each section listed below and place the appropriate documents in each corresponding section in a binder.
To excel in such cases delegates need research binders, to be able to organize information effectively and reach it quickly. Researching countries, committees, and topics for the conference is the most important thing you will need to prepare.
binder (synonyms: Regulatory Binder, Investigator Binder, Investigational Site File (ISF), and Study Binder) Details: • This document clarifies the standard content of the binder. • It is the responsibility of the investigator to ensure compliance with good clinical
A regulatory binder is also referred to as a study binder, investigator binder, administrative binder, regulatory file, or investigator's study files. For additional information about regulatory binders and management of research documentation, see Investigator Seminar Series session Documentation and Document Management in Clinical Research ...
Having a research binder will help you along the way of being the best delegate. Sources will also help you in delivering some of your best ideas.
A well-organised research binder can help you access key facts and arguments quickly during debates. Here are some essential tips to keep in mind: COUNTRY INFORMATION. Gather details about your country's position on relevant issues, UN voting history, and current foreign policy goals.
Building your Research Binder . While the goal of your Research is largely going to be to help you find facts to support your solutions in your position paper. Building a Research Binder can be extremely helpful when you find yourself in a committee room and you can’t use your laptop.
The term “Regulatory binder” refers to the place (and it’s not necessarily one place or even organized in a “binder”!) where regulatory documentation related to your research study is stored and updated. Your data is the ultimate product of your study, as it enables you to answer the study question and support or reject your hypothesis.
When researching for Model UN, you should think about five different types of research: Country Profile; Topic Background; Past International Action; Country Policy; Possible Solutions; Your research across these five categories should all go in to your “Research Binder”, which you should put together to prepare for a conference.