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Content of Regulatory/Study Binder. Human Subject Protection Office UConn Health Center Monika Haugstetter, MHA, RN, MSN & HSPO/IRB Staff. Introduction *. Definition/Significance of Regulatory Binder Method to organize/store study documents Essential documents

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Content of Regulatory/Study Binder

Human Subject Protection Office

UConn Health Center

Monika Haugstetter, MHA, RN, MSN

&

HSPO/IRB Staff


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


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.


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


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


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


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)


Content – Communication

  • Copy/proof of correspondence /communication (IRB, pharmacy, etc)

    • E-mails

    • Letters

    • Memos


Content – Non-compliance

  • Deviation Log

  • Copies of Problem Reports

  • Notes to file


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


Content – Monitoring Methods

If applicable:

  • Data Safety Monitoring Plan (DSMP)

    OR

  • Data Safety Monitoring Board (DSMB)

    • Charter

  • Reports/meeting minutes from DSMB or DSMP


Content – Audit/Monitoring

  • External Audits/Inspections/Monitoring Visit Reports

  • Site Monitoring Log

  • Internal Audit Reports (notifications/results/follow-ups)

  • Corrective action plans if applicable


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


Content - Personnel

  • Copies of professional Certificates/Licenses (MD, APRN, RN, etc.)

  • Appointment of Back–up PI form

  • Delegation of Responsibility/Signature Log


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


Content – Other Documents

  • Master (randomization) list of subjects

  • Lab normal values/ranges & certifications

  • Sponsor Reports / updates


Content – Summary

  • Flexibility – what works for your study

  • Attention to details

  • Ask colleagues for advice/tips

  • Keep it updated


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


!?Questions?!


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


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