Regulatory Binder: Maintaining Essential Study Documentation

1. Regulatory Binder: Maintaining Essential Study Documentation

2. Regulatory Binder • Based on ICH-GCP defined Essential Documents and OHRA’s Recordkeeping/Retention requirements • ICH-GCP: International Conference on Harmonization – Good Clinical Practice • Best Practice Standard • Provides a template for maintaining and organizing documentation to ensure compliance with federal regulations, institutional policies, and good clinical practice • Alternatives are acceptable. You can create your own way of organizing the required documentation in a way that works best for you and your study team. BE CONSISTENT!

3. Electronic Regulatory Binder (eBinder) The eBinders, developed in REDCap and Box.com, facilitate proper study management through electronic storage of study/regulatory documents and study management tools/logs. Instructions for institution-specific regulatory requirements, best practice recommendations, and GCP/Federal regulations are contained within each regulatory binder

4. Electronic Regulatory Binder (eBinder) • The eBinders allows you to: • Quickly download a custom template or utilize QIP’s template to customize your own binder to fit your study needs. • Maintain regulatory documents for one or multiple studies. • Securely share its contents with local and international study team members. • How to access the binders: • https://www.hsph.harvard.edu/ohra/quality-improvement-program-qip/study-management-tools/regulatory-binder/ Contains instructions for accessing our eBindertemplates in REDCap and Box.com. • Contact Stanley Estime to obtain access to the Box Template or if you have difficulty accessing REDCap’s eBinder.

5. Regulatory Binder Sections All Studies Study Specific Protocol CVs for all study staff Logs IRB Documentation Consent and Recruitment Materials Data Collection Materials Training Data Protection Licensure Investigator Brochure/ Device Manual/ Package Insert Laboratory Documentation Drug/Device NIH Sponsor DSMB External/Local Ethical Review

6. Essential Documents (all studies)

7. Essential Documents (all studies)

8. Essential Documents (all studies)

9. Essential Documents (all studies)

10. Participant Files • Maintain participant files securely and separate from the Regulatory Binder • Include original signed consent documents • Depending on confidentiality provisions outlined in the Research Protocol, signed consent forms may be kept separate from the participant’s research data • File completed data collection forms and source data • Communication with participants • As above, depending on confidentiality provisions outlined in the Research Protocol, communication that includes identifiers may be kept with signed consent documents and separate from research data

11. Single IRB and Multi-site Research • Include all institutional determinations and reliance agreements (SmartIRB or IRB Authorization Agreement and Institutional acknowledgments) in an External/Local Ethical Review file • Regulatory documentation should reflect any reliance agreements • The Overseeing IRB’s researchers should document up to date training and activities for all study staff that fall under the reviewing IRB’s oversight. • Most reliance agreements allow for the reviewing institution to conduct an audit, for cause, of the ceding institution’s study documentation • Regulatory documentation should still be kept at each institution to at least maintain site specific information. • The protocol will determine how Participant Files should be maintained at each site.

12. Tips for Successful Record Keeping Customize the Regulatory Binder to meet the specific criteria for your study Maintain binders in a secure location (e.g., locked file cabinet, password protected computer) Document and update materials in the Regulatory Binder in real time File hard copy documents in reverse chronological order (most recent on top)

13. Tips for Successful Record Keeping • Avoid maintaining duplicate records, particularly IRB documents (e.g., in ESTR, electronically on a shared drive, and hard copy in a paper-based Regulatory Binder) • Review documentation routinely • QIP recommends using the Investigator Self-Assessment as a guide when reviewing regulatory documentation • Address and resolve documentation issues immediately upon discovery

14. Note-to-File • A Note-to-File can reconcile many issues • When in doubt, write a note! • Use to explain apparent discrepancies • Use to identify location of files that are maintained outside of the Regulatory Binder (e.g., in electronic format on a shared drive or in ESTR) • Each note-to-file should include the study number, PI name, date, and the initials of the person writing the note-to-file

15. Record Retention • OHRA Policy: Maintain documentation for at least 7 years from study closure date • The Regulatory Binder and study documents, including participant files, must be maintained securely and readily available to auditors • Check with your sponsor to ensure compliance with their record retention policy

16. Resources • OHRA web site • https://www.hsph.harvard.edu/ohra/ • Quality Improvement Program (QIP) web site • https://www.hsph.harvard.edu/ohra/qip/ • QIP Study Management Tools - including Regulatory Binder tabs, Investigator Self-Assessment, and Note-to-File template • https://www.hsph.harvard.edu/ohra/qip/study-management-tools/

17. OHRA Quality Improvement Program (QIP) Alyssa Speier, MS, CIP Associate Director, Office of Regulatory Affairs and Research Compliance aspeier@hsph.harvard.edu 617 432-2140 Lisa Gabel, CIP Senior QA/QI Specialist lgabel@hsph.harvard.edu 617 432-5842 Scott Meyers, CIP QA/QI Specialist scmeyers@hsph.harvard.edu 617 432-2143