CRS Audit Readiness Reviews
February 14, 2014 - In order to serve the Consortium and assist the study teams as best we can, representatives from Regulatory Affairs and Monitoring conduct audit readiness reviews for studies that have upcoming audits. The purpose of the review is to assist study teams by assessing audit readiness and to provide recommendations regarding any additional preparation that might be needed for a successful audit. What is included?
The review includes visit logistics, regulatory binder(s), and research shadow charts. Your study coordinator should be present during our review and should be prepared to show how documentation of consent and eligibility will be presented to the auditor. In particular, we would like to know whether the auditor will use printed or online consent documents, eligibility checklists and source documentation of eligibility. As part of this review, we would like to examine some representative case-report forms either online or in printed form. The following study documentation should be available:
- Regulatory binder
- Delegation of authority current and complete
- CV/licenses match 1572/Delegation of authority
- IRB approvals, letters
- IRB reports (adverse events, deviations, annual reports, etc.)
- Subject research charts
- Consent form(s)
- Eligibility checklists
- Source Document
What happens next?
A report and recommendations (if any) will be sent to the Investigator and Coordinator after the review. We know that audits can be daunting and time-consuming, but we hope that these reviews help the process.
If you have received notification that your study is being audited, please contact Nora Olsen, Quality and Compliance Manager, at firstname.lastname@example.org or 206-667-2870.