Content of Regulatory/Study Binder

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Content of Regulatory/Study Binder

• Human Subject Protection Office
• UConn Health Center
• Monika Haugstetter, MHA, RN, MSN
• HSPO/IRB Staff

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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 binders 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

• 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

• 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/foll
  ow-ups)
• Corrective action plans if applicable

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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

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Content - Personnel

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

• 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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Referenceshttp//www.childrenshospital.org/cfap
ps/research/data_admin/Site2207/mainpageS2207P5.ht
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