Clinicaltrials.gov Program

Compliance Actions

Required actions and outstanding issues that are not resolved in a timely fashion by the Responsible Party may be escalated to the Clinical Affairs AVP via email.  The Clinical Affairs AVP will be responsible for the process of resolution of such issues and the associated administrative support needed to perform this function.

If you receive any correspondence from an external agency (including the FDA or NIH) regarding potential noncompliance of a CT.gov record, you must notify the Office of Research Compliance at ctgov@iu.edu immediately.