Clinical research monitoring

OVPRI performs routine risk-based monitoring on VCU-held IND/IDE studies, one-off monitoring visits on randomly selected studies, for cause monitoring and study initiation monitoring and education.

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).

If you have a study that you would like to have monitored on a routine basis, please contact indide@vcu.edu.

If you have a study that you would like a one-off monitoring visit done, please contact regaffairs@vcu.edu.

Monitoring program standard operating procedures

FDA regulations

FDA guidance    

Monitoring templates