Content of Regulatory/Study Binder

1. Content of Regulatory/Study Binder Human Subject Protection Office UConn Health Center Monika Haugstetter, MHA, RN, MSN & HSPO/IRB Staff

2. Introduction * • Definition/Significance of Regulatory Binder • Method to organize/store study documents • Essential documents • If not documented, never happened • Facilitates effective management of studies • May decrease procedural errors • Maintains events’ continuity (staff changes) • One person designated to maintain/update • Not required, but considered best practice

3. Binder Arrangement • Order of binder’s content • As preferred by research team • Flexibility • May be dictated by sponsor • Examples • Chronological order by date • Full board vs. expedited vs. modifications • Dedicated sections for protocol, ICFs, AE reports, IB, etc.

4. Content - Application Initial & Continuation Reviews material • Application (Initial & Continuation) • Application Checklist • IRB roster • Requests for Exempt/Expedited Reviews • Requests for Modification • Addendums, Appendixes & Forms • Approval letters

5. Content - Protocol • All versions of Protocol approved by IRB • Protocol Amendments • Recruitment/Advertising Materials (ads, flyers) • Case Report Forms (CRFs) (data collection forms) • Study Instruments

6. Content – ICFs & HIPAA • Informed Consent Form (ICF) Checklist • All versions of ICFs approved by IRB • All versions of HIPAA forms approved by IRB • Current ICF & HIPAA Authorization Form stamped/valid • Waivers (ICF/HIPAA) • Subject letters

7. Content – Personnel Compliance • Proof of CITI training • If personnel outside of UCHC, proof of their human subject training (CITI or other) • Copies of signed/dated CVs (Curriculum vitae) for PI and co-investigators • Conflict of Interest Form(s) (COI)

8. Content – Communication • Copy/proof of correspondence /communication (IRB, pharmacy, etc) • E-mails • Letters • Memos

9. Content – Non-compliance • Deviation Log • Copies of Problem Reports • Notes to file

10. Content – Adverse Events • MedWatch reports when applicable (http://www.fda.gov/medwatch/) • Serious Adverse Event (SAE) Reports (use UCHC on-line system to report) • Adverse Event (AE) Reports

11. Content – Monitoring Methods If applicable: • Data Safety Monitoring Plan (DSMP) OR • Data Safety Monitoring Board (DSMB) • Charter • Reports/meeting minutes from DSMB or DSMP

12. Content – Audit/Monitoring • External Audits/Inspections/Monitoring Visit Reports • Site Monitoring Log • Internal Audit Reports (notifications/results/follow-ups) • Corrective action plans if applicable

13. Content – Device/Drug Info If applicable • Investigator Brochure (IB) • Pharmacy arrangements • Drug/Device storage • Drug/Device Accountability Log • Form 1572 • IND/Device approval & indications • Significant vs. non-significant risk device determination

14. Content - Personnel • Copies of professional Certificates/Licenses (MD, APRN, RN, etc.) • Appointment of Back–up PI form • Delegation of Responsibility/Signature Log

16. Content – External Sites • Approval from external sites • Check for FWA (Federalwide Assurance) • Permission letters • If cooperative agreement in place, documentation that selected IRB of record accepts the other institution

17. Content – Other Documents • Master (randomization) list of subjects • Lab normal values/ranges & certifications • Sponsor Reports / updates

18. Content – Summary • Flexibility – what works for your study • Attention to details • Ask colleagues for advice/tips • Keep it updated

19. Contact Information • IRB support • Patty Gneiting (exempt/expedited) x4849 • Pam Colwell (panel 1 & 3) x1019 • Donna Horne (panel 2 & 3) x4851 • Marcy Chasse (outgoing approvals) x8729 • HSPO • Deb Gibb x3054 • Judy Gaffney x7555 • Monika Haugstetter x8802

20. !?Questions?!

21. References:*http://www.childrenshospital.org/cfapps/research/data_admin/Site2207/mainpageS2207P5.htmlReferences:*http://www.childrenshospital.org/cfapps/research/data_admin/Site2207/mainpageS2207P5.html