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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

Content of Regulatory/Study Binder

Human Subject Protection Office

UConn Health Center

Monika Haugstetter, MHA, RN, MSN

&

HSPO/IRB Staff

introduction
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
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
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
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
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
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
Content – Communication
  • Copy/proof of correspondence /communication (IRB, pharmacy, etc)
    • E-mails
    • Letters
    • Memos
content non compliance
Content – Non-compliance
  • Deviation Log
  • Copies of Problem Reports
  • Notes to file
content adverse events
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
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
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
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
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
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
Content – Other Documents
  • Master (randomization) list of subjects
  • Lab normal values/ranges & certifications
  • Sponsor Reports / updates
content summary
Content – Summary
  • Flexibility – what works for your study
  • Attention to details
  • Ask colleagues for advice/tips
  • Keep it updated
contact information
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
references http www childrenshospital org cfapps research data admin site2207 mainpages2207p5 html
References:*http://www.childrenshospital.org/cfapps/research/data_admin/Site2207/mainpageS2207P5.htmlReferences:*http://www.childrenshospital.org/cfapps/research/data_admin/Site2207/mainpageS2207P5.html
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