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Research and Innovation: Office of Research Regulatory Affairs
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  1. University of Arkansas for Medical Sciences
  2. Research and Innovation
  3. Office of Research Regulatory Affairs
  4. Departments
  5. Regulatory Affairs
  6. Monitoring Unit
  7. Study Management Tools
  8. Regulatory Binder

Regulatory Binder

  • Protocol
    • Initial protocol and all amendments
  • Informed Consent
    • All approved versions
  • Form 1572
    • All versions of Form 1572, signed and dated
  • CVs
    • Demonstrates qualifications of all investigator and associate investigators
    • Updated copies, should be signed and dated
  • Serious Adverse Events
    • Copies of Reports
    • Documentation of receipt from Institutional Review Board, sponsor, Food and Drug Administration, as applicable
  • IND Safety Reports
    • Copies of reports
    • Documentation of receipt from Institutional Review Board
  • Institutional Review Board Correspondence
    • Regarding approval process of the protocol, amendments
      • Submissions, stipulations, responses to stipulations
      • Does not need to be entire package
      • Keep enough documentation to provide a trail of the process
    • Regarding continuing review
      • Reminder notices
  • Institutional Review Board Letters
    • Institutional Review Board approvals
    • Continuing review approvals
  • Investigator’s brochure (IB)
    • All versions of the investigator’s brochure and updates
    • Contains scientific information for investigation product
    • For Food and Drug Administration approved agents, file a copy of the package insert
  • Recruitment advertisements/letters
    • With documented Institutional Review Board and sponsor approvals
  • Sponsor Correspondence
    • Pre-study correspondence as appropriate
    • Details processes and procedures for study conduct
    • Phone logs
    • Site visit letters/summaries
  • Correspondence
    • Any miscellaneous protocol-related correspondence
  • Laboratory Certification
  • All copies of CLIA certifications for all labs submitting subject results for purpose of the study.
    • Need to have valid certifications filed as long as the study is open
  • Subject Enrollment/Screening Log
    • Log to document chronological enrollment of subjects
    • Log to document patients who entered pre-trial screening period
    • Should document why potential subjects were not included in the study.
  • Delegation Log
    • List of the signatures and initials of all persons authorized on the study.
  • Site Visit Log
    • Log in which monitors will document their visits
    • Site staff will have a place to initial/verify that monitor was present on specific dates
  • Pharmaceutical Information
    • Drug accountability including shipping and dispensing records
    • Sample of labels attached to investigational product containers
  • Case Report Forms
    • Approved case report forms
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Mailing Address: 4301 West Markham Street, Little Rock, AR 72205
Phone: (501) 686-7000
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