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Transcript of Content of Regulatory/Study Binder Human Subject Protection Office UConn Health Center Monika...
Content of Regulatory/Study Binder
Human Subject Protection OfficeUConn Health Center
Monika Haugstetter, MHA, RN, MSN&
HSPO/IRB Staff
October 2008 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
October 2008 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.
October 2008 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
October 2008 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
October 2008 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
October 2008 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)
October 2008 8
Content – Communication
• Copy/proof of correspondence /communication (IRB, pharmacy, etc)
– E-mails – Letters– Memos
October 2008 9
Content – Non-compliance
• Deviation Log
• Copies of Problem Reports
• Notes to file
October 2008 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
October 2008 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
October 2008 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
October 2008 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
October 2008 14
Content - Personnel
• Copies of professional Certificates/Licenses (MD, APRN, RN, etc.)
• Appointment of Back–up PI form
• Delegation of Responsibility/Signature Log
October 2008 15
October 2008 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
October 2008 17
Content – Other Documents
• Master (randomization) list of subjects
• Lab normal values/ranges & certifications
• Sponsor Reports / updates
October 2008 18
Content – Summary
• Flexibility – what works for your study
• Attention to details
• Ask colleagues for advice/tips
• Keep it updated
October 2008 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
October 2008 20
!?Questions?!
October 2008 21
References:*http://www.childrenshospital.org/cfapps/research/data_admin/Site2207/mainpageS2207P5.html