CTQA FAQ

External Monitoring Letters/Audit Reports

What is considered an external monitoring letter/audit report?

External monitoring letters/audit reports should be submitted to CTQA when monitoring is performed by an individual(s) that do not work in your department (e.g., sponsor/CRO monitor letters and NCTraCS monitoring letters)

Why are external monitoring letters/audit reports submitted to CTQA?

External monitoring letters/audit reports are submitted to CTQA to ensure compliance with regulations/guidelines/UNC policies, etc. The information may be used to determine educational opportunities and identifies studies where CTQA may be of assistance.

When do external monitoring letters/audit reports need to be submitted to the CTQA mailbox (CTQA@unc.edu)?

External monitoring letters should be submitted to CTQA when the renewal is submitted in IRBIS, as each study that has been monitored will be included on the IRBIS weekly CTQA monitoring report at the time the renewal is submitted. CTQA staff will reconcile the report with monitoring letters/audit reports received.

Will you be notified when the external monitoring/audit reports are reviewed?

You will receive a response notifying you that the letters have been reviewed and logged into our database.

Please send any questions to the CTQA@unc.edu mailbox.