1. Research Study Regulatory Binder Ronald Cowan, MD, PhD J. Gavin Lillevig, BS Summer Professional Didactics Data Management Psychiatric Neuroimaging Program Department of Psychiatry Vanderbilt University School of Medicine Nashville, TN – July, 2008

2. PURPOSE The purpose of your regulatory binder should serve three- fold: Streamline work processes by compiling all study related documentation in one place Allowing ease of access to most current documentation to all personnel with minimal effort A tool for monitoring regulations and standards set by federal departments (FDA, HHS, OHRP), your sponsor (NIH), and local regulatory bodies (IRB)

3. LAYOUT Files should be customized to the demands of the study Organization Tabs and/or sub-tabs Tabs and/or sub-tabs Most frequently accessed documents should be in the front Most frequently accessed documents should be in the front Reverse chronological order Reverse chronological order Clean copies of documents (may include marked copies as well) Clean copies of documents (may include marked copies as well) IRB approval letters (FALs) for each document IRB approval letters (FALs) for each document

4. Identifying Elements Cover and Binding Label Cover and Binding Label IRB study number Study title PISponsor Institution and location Book number (if multiple books) Title Page Title Page IRB number and study title Book number (if multiple books)

5. Administrative Documents Regulatory File Checklist Regulatory File Checklist Itemizes each element Notates they are present in the binder Notates dates when documents were changed Additional comments Memos Memos You may include memos in the reg. binder Memos document missing items or changes in the organizational structure of the reg. binder

6. Structure Protocol Protocol All final IRB approved versions of the study protocol in reverse chronological order. All final IRB approved versions of the study protocol in reverse chronological order. May include marked copies Should include IRB approval letters (FALs) Consent Consent MOST CURRENT APPROVED CONSENT SHOULD BE FIRST (recommend plastic cover) Previous expired consents with IRB approval letter

7. Structure IRB Correspondence IRB Correspondence All informal correspondence with the IRB (emails, faxes, phone log) Submissions/Continuing Review Submissions/Continuing Review Initial Submission HS application, RDRC application, Protocol, Consent, study documents, FDA applications, etc. HS application, RDRC application, Protocol, Consent, study documents, FDA applications, etc. NOTE: These documents are what you submit to the IRB. After approval, place an approved copy in the appropriate sections with a FAL (IRB Letter) NOTE: These documents are what you submit to the IRB. After approval, place an approved copy in the appropriate sections with a FAL (IRB Letter) Continuing review applications

8. Structure Amendments Amendments Reverse chronological order Each amendment should be sub-tabed with a title page (recommend colored paper) Amendment number Amendment number IRB Study No. / Title IRB Study No. / Title Submitters initials Submitters initials Date submitted Date submitted Date approved Date approved Documents included / summary of changes Documents included / summary of changes Clean copies of submitted documents (may include marked) Approval letter on top. Again, approval letters for consents should be filed with the consent forms.

9. Structure Adverse Events Adverse Events Protocol Deviations Protocol Deviations Key Study Personnel Key Study Personnel Research study signatory log Notates all study personnel and their dates of involvement in the project Notates all study personnel and their dates of involvement in the project CVs of all current key study personnel Documentation of trainings, formal and informal (Ex. Documenting phlebotomy training by itemizing dates of supervision or observation)

10. Structure Case Report Form (CRF) Case Report Form (CRF) Data management tool Purpose is to streamline data entry process Snapshot of all participant data (identified or de- identified) that goes into your database Participant code number, age, gender, educational level, height, weight, BP, questionnaire scores, etc. Participant code number, age, gender, educational level, height, weight, BP, questionnaire scores, etc. A blank CRF template is filed in the binder CRF Appendix All questionnaires or forms the participant actually completes (Demographic, financial, etc.) All questionnaires or forms the participant actually completes (Demographic, financial, etc.)

11. Structure Laboratory Laboratory Certificate of accreditation CV of laboratory director Copy of normal ranges or criteria for classifying samples Banking log of samples (optional) Advertising / Recruitment Advertising / Recruitment Screening log with de-identified information Enrollment log Approved IRB ads or language

12. Structure Standard Operating Procedures (SOP) Standard Operating Procedures (SOP) Detailed instructions of work flow Someone should be able to come into your lab and run your study from the SOP Examples of elements in an SOP Phone script for screening, directions to the DNA Core Lab and how to bank samples, Instructions on data entry and questionnaire scoring, etc. Phone script for screening, directions to the DNA Core Lab and how to bank samples, Instructions on data entry and questionnaire scoring, etc. Ensures consistency between personnel changes Not required, but an example of a best practice policy

13. Structure Sponsor Sponsor All correspondence with the sponsor (formal and informal) Copy of the grant Other sponsor related documents Misc Misc Catch-all tab for things you are not quite sure what to do with

14. Conclusion Regulatory binder is a tool that should fit the demands of the study and expectations set by regulating bodies Regulatory binder is a tool that should fit the demands of the study and expectations set by regulating bodies Organized in a logical fashion with most frequently accessed items in the front Organized in a logical fashion with most frequently accessed items in the front Should be in a central location where all approved personnel may access the documents Should be in a central location where all approved personnel may access the documents Updated on a regular basis Updated on a regular basis

15. Resources Research Support Services Research Support Services Hotline: (615)-322-7343 (GREAT RESOURCE) http://www.mc.vanderbilt.edu/root/vumc.php?site= support http://www.mc.vanderbilt.edu/root/vumc.php?site= support Regulatory Binder Templates Regulatory Binder TemplatesStarBRITE http://www.mc.vanderbilt.edu/root/vumc.php?site= support&doc=3398 http://www.mc.vanderbilt.edu/root/vumc.php?site= support&doc=3398

16. References Information in this presentation was adapted from the curriculum of the Clinical Research Immersion Course developed by Research Support Services, Vanderbilt University Research.support.services@vanderbilt.edu Research.support.services@vanderbilt.edu Research.support.services@vanderbilt.edu (615) 322-7343 (615) 322-7343