Monitoring and Audits

UNC Investigators who hold an IND (investigator-sponsor) have an obligation for monitoring of the research protocol:

  • The sponsor shall monitor the progress of all clinical investigations being conducted under its IND (21 CFR 312.56a).

The Regulatory study monitoring service is available to help investigators understand their obligations and how best to meet the monitoring requirements of the trial.

If you are an investigator anticipating an FDA or NIH audit of your study, you may request guidance and support from our team as you begin pre-audit preparation. We also provide assistance with document organization and SOP development for your research protocols.

Contact us or request a consult for assistance with an audit, development of source documents, case report forms, SOPs and document organization.