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
- IRB Letters and Documents including, but not limited to: