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Research and Innovation: Office of Research Regulatory Affairs
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          • Adverse Event Log (Device)
          • Adverse Event Log (Drug)
          • Compensation Log
          • Concomitant Medication Log
          • Delegation of Authority Log
          • Deviation Log
          • Device Accountability Log
          • Device Accountability Log (Use)
          • Eligibility Checklist
          • IND – IDE Monitoring Plan
          • Informed Consent Process Note
          • Regulatory Binder Contents
          • Role of the Medical Monitor
          • Screening-Enrollment Log
          • SIV Agenda
          • Source Data Agreement
          • Specimen Tracking Log
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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 Contents

Regulatory Binder Contents

  • Protocols
    • Most current IRB-approved version (clean and tracked)
    • All previous versions submitted to IRB (clean and tracked)
  • Informed Consents and HIPAA Forms
    • Most current IRB-approved version (clean and tracked)
    • All previous versions submitted to IRB (clean and tracked)
  • Monitoring Plan
    • All signed and dated versions
  • Financial Disclosure Forms
    • All signed and dated versions for Principal Investigator and Sub-Investigators
  • Sponsor-Site Agreements
    • All signed and dated versions
  • FDA Form 1572s (IND Studies)
    • All signed and dated versions
  • Investigator Agreements (IDE Studies)
    • All signed and dated versions
  • Investigator Brochures (IB) / Product Package Inserts (PPI) (IND Studies) OR Device Manuals (IDE Studies)
    • Most current version(s)
    • All previous versions
  • IRB Correspondence
    • All correspondence with the IRB including but not limited to:
      • Submissions (signed and dated versions)
        • New
        • Modification
        • Staff
        • Reportable New Information
      • Supporting documents (all submitted to IRB)
        • Advertisement/ flyers/ recruitment information
        • Information given to subjects
        • Case Report Form templates
        • Letters/ emails from PI
        • Letters/ emails from Sponsor
        • Audit reports/ findings/ letters
        • Adverse Event Logs
        • Deviation Logs
        • Publications/ Articles/ Abstracts
        • Annual Progress Reports (IDE studies)
  • IRB Letters
    • All letters from the IRB including but not limited to:
      • Reminders
      • Contingencies
      • Approval
        • New submission
        • Modification
        • Staff
        • Continuing Review
  • Certifications, Accreditations for Medical/ Laboratory/ Technical Procedures/ Tests
    • CLIA and CAP certifications for all labs submitting subject results for purpose of the study
    • Laboratory values/ normal ranges of study-related lab tests (updated every 2 years)
    • Laboratory SOPs, procedure manuals
    • CV/ Medical License/ CITI HSPT Training for Lab Director

  • Subject Screening-Enrollment Log
    • Document chronological screening-enrollment of subjects
    • Document reasons why potential subjects were not enrolled as well as screen fails and withdrawals
  • Delegation Log
    • List of the signatures and initials of all persons authorized on the study
    • Document study-related activities that the PI has delegated
  • Monitor Site Visit Log
    • Log in which monitors will document their visits, to be counter-signed by study staff
  • Adverse Event Log
    • Comprehensive list of adverse events while subjects are on study (overall or subject-specific)
  • Deviation Log
    • Comprehensive list of deviations while subjects are on study (overall or subject-specific)
  • Specimen Tracking Log
    • Comprehensive list of all specimens collected and the shipment information for each specimen
    • Requisition sheets for samples obtained
  • Investigational Product Information
    • Drug/ Device accountability logs
    • Shipping and dispensing records
    • Calibration and Maintenance records (IDE studies)
    • Sample of labels attached to investigational product and materials
    • Instructions for handling investigational product and materials
  • Case Report Forms
    • Case Report Forms, current and retired versions
  • Investigator Qualification Documentation (updated copies on file throughout study)
    • CVs
      • Demonstrates qualifications of Principal Investigator, Sub-Investigators, Medical Monitor, staff
      • Copies in file should be signed and dated every 2 years
    • Professional License
      • Demonstrates qualifications of Principal Investigator, Sub-Investigators, Medical Monitor, staff
  • Training Documentation (updated copies on file throughout study)
    • CITI Human Subjects Training for all delegated study staff
    • CITI Good Clinical Practice for PI and Sub-Investigators only
    • Study-Specific Training for all delegated study staff, including initial protocol and amendments
  • Serious Adverse Events documents
    • Copies of SAE Reports and documentation of receipt from IRB, Sponsor, FDA, as applicable
    • Copies of IND Safety Reports and documentation of receipt from IRB and FDA, as applicable
  • Sponsor Correspondence
    • ClinicalTrials.gov information
    • Pre-study correspondence, including details of processes and procedures for study conduct
    • Monitoring Visit correspondence (including reports, letters, communication)
    • Annual Progress Reports
    • Record of Final Disposition of Study Records
    • Record of Final Disposition of Investigational Drug/ Device
  • Correspondence
    • Any miscellaneous protocol-related correspondence, including but not limited to:
      • Letter of Understanding/ Confidentiality Agreement
      • Data Sharing Agreement
      • Material Transfer Agreement
      • Signed agreements between parties (i.e., sponsors/investigators)
      • Important decisions regarding study conduct, such as Notes to File
      • Data Safety Monitoring Documents
      • Other study documents, as necessary

  • Do not file items such as financial records, budget documents, records related to other studies, non-study related personnel records, and auditing reports within the regulatory binder.  These documents are usually not open to regulatory agencies. 

Create Note-to-File indicating central filing location of documents

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Mailing Address: 4301 West Markham Street, Little Rock, AR 72205
Phone: (501) 686-7000
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