Monitoring is one of the most essential aspects of a clinical study. But what happens if your monitors are untrained or make costly mistakes? After spending millions of dollars and years of hard work, the results could very well render your study insufficient by the Food and Drug Administration.

Common monitoring mistakes include:

  1. Not having adequate expertise with the protocol.
  2. Settling for inadequate source documentation.
  3. Not asking the “right” questions– both from the site and the sponsor.
  4. Lack of timely follow-up with the site and sponsor.
  5. Not allowing adequate time for the monitoring visit.
  6. Arriving to the monitoring visit unprepared.

Study monitoring falls under ICH-GCP Guidelines (pdf).  These Guidelines, specifically section 5.18, discuss the roles of the monitors and the responsibilities they have, along with the responsibility of the sponsor in choosing highly trained and knowledgeable monitors. By utilizing the following steps, you can rectify most of the common mistakes that occur:

  1. Review and re-review all protocol changes as well as changes to the data collection methods as they occur during the study.
  2. Be sure your monitors are trained and certified through an accredited program.
  3. Ensure they are staying current with their continuing education courses, which is required to maintain certification.
  4. Provide in-house training programs that require participation and feedback.
  5. Communicate, communicate and communicate.

Monitors typically work from home offices and tend to be isolated from the day-to-day activities of the study.  Having weekly conference calls to review issues that arise from monitoring visits, changes to the protocol/data collection, and keeping your monitors engaged is often one great step that can prevent mistakes from occurring.

Following these steps will help you  build a stronger relationship with your monitors, and it will also  ensure data integrity and FDA compliance.  At the end of the day having an excellent team of monitors will get your product to market faster.

Teresa can be reached at tschroeder@mcra.com.