Advice for Site Monitor Visits Every Clinical Research Coordinator Should Know

As a clinical study coordinator, what should I do before a Clinical Research Associate (my CRA) arrives for monitoring?

Planning Prior to Monitoring Visit (MV)

  1. Schedule a mutually convenient date and time to conduct the MV with the CRA, assuring the availability of study team as required
  2. Collate the study subject files, Screen Fail subject notes, and also Randomized patient records
    • Ensure all Informed Consent Forms are filed
    • Check for complete records documenting the investigational procedures required per protocol at each visit (i.e. ECG tracings, laboratory results, etc.)
    • Ensure that all data queries in the Case Report Forms (CRF) are resolved
  3. Check the last Monitoring Visit Follow up letter to review and address pending items recorded from previous monitoring visit
  4. Prepare electronic Medical Records (EMR) for CRA for their usage during monitoring visit
  5. Inform all required study team of the expectation to be present during the MV
    • Remind all of the required study team 2 days before prior to the Monitoring Visit
    • Inform Pharmacist in charge regarding the planned monitoring visit as they will be need to available to the CRA and provide the complete pharmacist binder, and access to Investigational Product (IP) & updated temperature/dispensing/accountability logs for review
    • Inform Principal Investigator (PI) regarding the visit and check on their availability during the visit – this is important so that CRA could solve any pending issues during the site monitor visits

During Site Monitor Visits

      1. Arrive early for days with site monitor visits to ensure all the required items are available for CRA
      2. Greet and inform the CRA on the plan for the day and scheduled appointment times to meet with the PI and pharmacist
      3. Accompany monitor to visit specific areas : Subject’s treatment area, IP storage area
      4. Accompany Monitor to resolve CRF discrepancies, entry errors, omissions, or illegibility concerns in site during the monitoring visit
      5. Raise all the pending issue regarding study ,eg : payment, patient recruitment, IP
      6. Ensure the CRA signs the Site Monitor Visits log

Best Practices Post Monitoring Visit

      • Return all source documents to respective department in a timely manner
      • Resolve all queries and pending items within 5 working days

Reference

1. ICH Guidelines for Good Clinical Practice
2. STANDARD OPERATING PROCEDURE FOR RESEARCH: SOP 12. Monitoring Visit, Basildon and Thurrock University Hospitals NHS FT Research & Development
3. Monitoring & Auditing of Clinical Trials, Center for Cancer Research National Cancer Institute

About The Author

Mohana Priya Velesamy

Mohana Priya Velesamy graduated with a Bachelor in Medical Science (Hons) in 2010 and started her career in clinical research when she joined Clinical Investigator Center( CIC), University Malaya Medical Center In 2011 as an Oncology study coordinator. She is an effectively articulate communicator with her clinical trial colleagues and shares her clinical research advice with you. Currently she is working with Clinical Research Malaysia as Senior Study Coordinator for the Oncology Department.