FAQs on the Submission of Monitoring Letters & Audits Reports

What monitoring letters/audit reports should be submitted to the CTQA?

External monitoring letters/audit reports, completed by an individual(s) outside your department, must be submitted to the CTQA (e.g., sponsor/CRO monitor letters and NC TraCS monitoring letters)

Why do we need to submit external monitoring letters/audit reports to CTQA?

These documents are submitted to the CTQA to ensure compliance with regulations/guidelines/UNC policies, etc. The information may be used to determine educational opportunities and determine where CTQA can provide assistance.

Where do we submit external monitoring letters/audit?

External monitoring letters/audit reports need to be submitted to the CTQA Mailbox.

When should external monitoring letters/audit reports be sent to the CTQA?

Submit external monitoring letters to CTQA when the renewal is submitted in IRBIS. Each monitored study will be included in the IRBIS weekly CTQA monitoring report at the time of renewal submission. CTQA staff will reconcile this report with the received monitoring letters/audit reports.

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

Yes, you will receive a notification confirming that the letters have been reviewed and logged into our database.

Who should I contact if I have question about the submission of monitoring letters/audit report?

Please send your questions to the CTQA Mailbox.