Content of Regulatory Binder

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Transcript Content of Regulatory Binder

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
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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.
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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
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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
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Content – ICFs & HIPAA
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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
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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)
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Content – Communication
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Copy/proof of correspondence
/communication (IRB, pharmacy, etc)
– E-mails
– Letters
– Memos
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Content – Non-compliance
• Deviation Log
• Copies of Problem Reports
• Notes to file
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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
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Content – Monitoring Methods
If applicable:
• Data Safety Monitoring Plan (DSMP)
OR
• Data Safety Monitoring Board (DSMB)
– Charter
• Reports/meeting minutes from DSMB or
DSMP
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Content – Audit/Monitoring
• External Audits/Inspections/Monitoring
Visit Reports
• Site Monitoring Log
• Internal Audit Reports
(notifications/results/follow-ups)
• Corrective action plans if applicable
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Content – Device/Drug Info
If applicable
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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
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Content - Personnel
• Copies of professional
Certificates/Licenses (MD, APRN, RN, etc.)
• Appointment of Back–up PI form
• Delegation of Responsibility/Signature Log
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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
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Content – Other Documents
• Master (randomization) list of subjects
• Lab normal values/ranges & certifications
• Sponsor Reports / updates
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Content – Summary
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Flexibility – what works for your study
Attention to details
Ask colleagues for advice/tips
Keep it updated
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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
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!?Questions?!
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References:
*http://www.childrenshospital.org/cfapps/research/data_admin/Site2207
/mainpageS2207P5.html
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