Clinical research monitoring

Lead institution sponsor-investigators shall monitor the progress of all clinical investigations being conducted under its IND/IDE. (21 CFR § 312.56; 21 CFR § 812.46). FDA inspects sponsor-investigators. The FDA inspector findings common to sponsors, investigators, and sponsor-investigators are reported annually by FDA.

Common sponsor-investigator findings include failure to ensure proper monitoring, failure to submit an IND, adherence to the protocol, adequate records, drug accountability, patient-subject protection issues, consent issues, and failure to timely notify FDA of terminated investigators.

Goals of monitoring   

  1. keeping participants safe and respecting their rights;
  2. having data we can trust;
  3. making sure the trial was run as it was meant to be;
  4. improving the way the trial is run; and
  5. preventing problems before they happen.

Study monitors may be tasked with spot-checking for inconsistencies or omissions, checking for completeness and consistency, source document verification and consistency between paper and electronic sources, identifying sites meriting further review, and the use of current consent and IRB documents.     

Clinical studies in the US are overseen and may be audited by the Food and Drug Administration (FDA).  Additionally, studies are overseen by the Institutional Review Board (IRB).

OVPRI provides monitoring services to all sponsor-investigator IND/IDE held studies throughout the course of the study that fulfills the FDA’s requirement for monitoring.  Each study will have an individualized monitoring plan established at the start of the study.  Monitoring frequency will vary based on complexity of the study and the rate of accrual.

If you have a study that you would like to have monitored on a routine basis, please contact

FDA regulations

FDA guidance    

Monitoring templates