IRB Cheat Sheet: Tips and Tools for keeping our study organized and regulatory compliant

1. Alyssa Speier, MS, CIP November 13, 2013 IRB Cheat Sheet: Tips and Tools for keeping our study organized and regulatory compliant qip@hsph.harvard.edu www.hsph.harvard.edu/ohra/qip

2. Agenda ICH-GCP Guidelines QIP Regulatory Binder Review of Contents/Sections Participant Files Record Retention Tips for Successful Record Keeping General Correction Do’s/Don’ts Electronic Record Keeping Questions & Additional Resources

3. ICH-GCP Guidelines International Conference on Harmonization (ICH)- Good Clinical Practice (GCP) International ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human participants Defines Essential Documents as those that “individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced” Demonstrates compliance Serves as best practice standard 3

4. QIP Regulatory Binder Based on GCP list of Essential Documentsand OHRA’s Recordkeeping/Record Retention requirements Provides a template for maintaining and organizing documentation to ensure compliance with federal regulations, institutional policies and good clinical practice Alternatives exist: You can create your own way of organizing these documents that works best for you and your study team just BE CONSISTENT QIP provides record keeping recommendations and a regulatory binder based on best practices A study specific Binder will be provided based on the type of research being conducted (e.g., Social Behavioral, Biomedical, or FDA) 4

5. Study-Specific: Lab Documents FDA Investigational Brochure Drug/Device Financial Disclosure NIH Sponsor DSMB Local Review Binder Sections Overview(Essential Documents where applicable) All Studies: • Protocol • Staff CVs • Staff Licensures • Logs • IRB Documents • Consent Forms • Data Collection • Training 5

6. Essential Documents (All Studies)

7. Essential Documents (All Studies)

8. Essential Documents (All Studies) Considerations for source documentation and data collection tools: Do not leave blank information (NA/ND/UNK).

9. Essential Documents (All Studies)

10. Study-Specific Documents Sponsored • Financial Disclosure • NIH • Sponsor Data Monitoring • DSMB International • Local Review Tissue/blood Specimens • Laboratory Documents Drug/Device • FDA 1572 (drug) or Investigator Agreement (device) • Investigational Brochure (drug) or Device Manual (device) • Drug/Device Accountability • IND/IDE Application 10

11. Study-Specific Documents:Laboratory Laboratory certification - review for expiration CAP/CLIA Lab Director’s CV Normal lab values/Reference ranges Note: Copies of laboratory documentation can be obtained from your sponsor or the clinical laboratory personnel 11

12. Study-Specific Documents:Drug/Device Sponsor-Investigator: • Initial IND or IDE Application with 1571 • Amendments to the Application • Adverse Event Reports • Annual Reports • Clinical Investigator drug/device documents Clinical Investigator: • 1572 (drug) or Investigator Agreement • Investigator’s Brochure or Device Manual • Drug/Device Accountability Log 12

13. NIH and Sponsor Documents NIH Documentation Copy of most recent progress report with enrollment table NIH grant application information Additional study correspondences with NIH Sponsor Documentation All ‘significant’ correspondences to and from the sponsor (e.g., letters, meeting minutes and telephone call notes)

14. DSMB Documentation Reports from DSMB meetings Additional correspondences with DSMB: E-mails Letters Meeting minutes

15. Local Review Local review is required for studies conducted abroad A copy of local ethical approval notice(s) For HHS-funded protocols: Review should be done by IRB of collaborating institution or another institution in geographical area Local IRB must be registered with OHRP and have FWA on file For non HHS-funded protocols: Review should be done by local ethical review board or community advisory board

16. Participant File Documents Documentation of Eligibility Documentation of Consent Data Collection Tools Note-to File • Questionnaires • Participant Diaries • Demographics Form • Medical History Form • Physical Exam Form • Lab Collection Form • etc.

17. Participant Files • Original signed and dated informed consent documents • Completed data collection forms • Source documentation • Significant communication with participants 17

18. OHRA Record Retention Policy • Maintain documentation at least 7 years from study closure date • Check with sponsor to ensure compliance with their record retention policies 18

19. Tips for Successful Record Keeping • Address and resolve documentation problems immediately • Review documentation routinely • Document and update materials in real time 19

20. Tips, continued…Study Record Corrections Do’s • Make one line through the incorrect entry • Retain readability of incorrect entry • Write the corrected entry beside it • Initial and date the correction Dont’s • Use White-Out • Obliterate an entry • Use different color inks • Sign the investigator’s or any other name 20

21. Tips, continued…Electronic Recordkeeping Maintain signed and dated note-to-file indicating the location of electronic correspondences. Ensure that electronic copies are available to study staff and regulatory authorities. Ensure privacy and confidentiality is maintained for participant files stored electronically. Maintain copies of documents and correspondences with the original signatures (pdf). 21

22. Questions? Quality Improvement Program Staff • Stanley Estime, sestime@hsph.harvard.edu, 617-432-2164 • Lisa Gabel, lgabel@hsph.harvard.edu, 617-432-5842 • Leslie Howes, lhowes@hsph.harvard.edu, 617-432-2153 • Alyssa Speier, aspeier@hsph.harvard.edu, 617-432-2140 IRB Operations Staff • Department Assigned IRB Review Specialist: http://www.hsph.harvard.edu/ohra/department-assignments/ • Julie Kaberry (IRB Administrative Chair), jkaberry@hsph.edu, 617-432-2149 Resources • OHRA Website: http://www.hsph.harvard.edu/ohra 22