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

2. October 20082 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. October 20083 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. October 20084 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. October 20085 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. October 20086 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. October 20087 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. October 20088 Content – Communication Copy/proof of correspondence /communication (IRB, pharmacy, etc) –E-mails –Letters –Memos

9. October 20089 Content – Non-compliance Deviation Log Copies of Problem Reports Notes to file

10. October 200810 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. October 200811 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. October 200812 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. October 200813 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. October 200814 Content - Personnel Copies of professional Certificates/Licenses (MD, APRN, RN, etc.) Appointment of Back–up PI form Delegation of Responsibility/Signature Log

15. October 200815

16. October 200816 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. October 200817 Content – Other Documents Master (randomization) list of subjects Lab normal values/ranges & certifications Sponsor Reports / updates

18. October 200818 Content – Summary Flexibility – what works for your study Attention to details Ask colleagues for advice/tips Keep it updated

19. October 200819 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. October 200820 !?Questions?!

21. October 200821 References: *http://www.childrenshospital.org/cfapps/research/data_admin/Site2207 /mainpageS2207P5.html