Preparing for a Scheduled QA/QI Review

Investigators should review the information listed below prior to initiating a new research study as it will help to ensure regulatory compliance and good clinical practices.

  • Confirm the date and time for the audit, as well as the anticipated duration of the QA/QI Review. Ascertain whether the QA/QI team will require the use of any specific equipment.
  • Ensure that all research team members are aware of the upcoming QA/QI Review.
  • Ensure that the principal investigator and senior study coordinator are available for the QA/QI Review.
  • Ensure that the following documents will be available and accessible during the review in hard copy and/or electronic format (copies are not necessary unless the QA/QI team specifically requests them during the review):
    • IRB Letters and Documents including, but not limited to:
      • Initial Review
      • Continuing Reviews
      • Amendments
      • Adverse or Unanticipated Event Reports
      • Deviation Reports
    • IRB Approved Documents including, but not limited to:
      • Approved Protocol
      • Approved Consent/Assent Forms
      • Approved Recruitment Materials
      • Other Approved Study Materials (e.g., surveys, questionnaires, etc.)
    • IRB Participant Documents including, but not limited to:
      • Signed Consent/Assent Forms
      • Subject Enrollment, Screening and/or Payment Logs
      • Subject Study Records
    • If applicable, FDA Regulatory Documentation for Drug/Device Trials
    • If applicable, Grant Proposal and Correspondence with Funding Sponsor