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