Research Study Regulatory Binder

1. Research Study Regulatory Binder Summer Professional Didactics Data Management Ronald Cowan, MD, PhD J. Gavin Lillevig, BS 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 • Most frequently accessed documents should be in the front • Reverse chronological order • Clean copies of documents (may include marked copies as well) • IRB approval letters (FALs) for each document

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

5. Administrative Documents • Regulatory File Checklist • Itemizes each element • Notates they are present in the binder • Notates dates when documents were changed • Additional comments • 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 • All final IRB approved versions of the study protocol in reverse chronological order. • May include marked copies • Should include IRB approval letters (FALs) • Consent • MOST CURRENT APPROVED CONSENT SHOULD BE FIRST (recommend plastic cover) • Previous expired consents with IRB approval letter

7. Structure • IRB Correspondence • All informal correspondence with the IRB (emails, faxes, phone log) • Submissions/Continuing Review • Initial Submission • 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) • Continuing review applications

8. Structure • Amendments • Reverse chronological order • Each amendment should be sub-tabed with a title page (recommend colored paper) • Amendment number • IRB Study No. / Title • Submitters initials • Date submitted • Date approved • 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 • Protocol Deviations • Key Study Personnel • Research study signatory log • 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) • 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. • A blank CRF template is filed in the binder • CRF Appendix • All questionnaires or forms the participant actually completes (Demographic, financial, etc.)

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

12. Structure • 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. • Ensures consistency between personnel changes • Not required, but an example of a best practice policy

13. Structure • Sponsor • All correspondence with the sponsor (formal and informal) • Copy of the grant • Other sponsor related documents • 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 • 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 • Updated on a regular basis

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