Audits are conducted on UNC Lineberger investigator-initiated treatment trials to authenticate compliance and capture of accurate data through the UNC Lineberger Compliance Committee (CC). The Committee’s main purpose is to support investigators and staff by ensuring the safety of study participants and compliance with protocols, regulations, and standard operating procedures (SOPs) for the clinical trials conducted at UNC Lineberger. This oversight is accomplished by a forum for review of clinical trial activities and dissemination of best practices information.
The Compliance Committee meets the 4th Monday of every month except for a combined November/December meeting which meets the 2nd Monday of December.
The Compliance Committee reviews and approves all UNC Lineberger Corrective and Preventative Action Plans (CAPAs) for UNC and affiliate sites resulting from an Office of Clinical Trials (OCT) audit. This review may include requiring Root Cause Analysis (RCA/reactive) or Failure Mode and Effects Analysis (FMEA/preventive) sessions be conducted by investigators and staff.
Submission information and requirements
The Compliance Committee reviews audited oncology studies from UNC Lineberger IITs. Please contact the DSM Coordinator at email@example.com with questions about the review process.
Information for Compliance Committee Review
The study team will submit a Compliance Committee submission to the DSM Coordinator upon IRB or OCT approval of the CAPA(s) outlined in an OCT audit report. Submissions should be sent in a single email. If the study requires multiple CAPAs, submissions should be sent upon full approval of all CAPAs. Studies will be added to the next available agenda once all approved CAPAs are received.
Required Documents for Compliance Committee Review
For each CAPA submitted to the Compliance Committee, summary information must include an RCA, CAPA, plan for effectiveness check, and supporting documentation. For more information, please review OHRE SOP 1401.
- Compliance Committee Study Report Forms
- Forms last updated October 24, 2022
- Form for CAPA Review
- Required Supporting Documentation
- OCT Audit Report
- All submitted PRIs
- All requested stipulations
- IRB response letters
- OCT response correspondence
- Any other related documents