How to Monitor Clinical Trials

Clinical trial monitoring is the administrative process by which oversight of a clinical trial is conducted. A clinical trial monitor performs several activities including checking clinical site activities, performing on-site reviews, verifying that data is consistent, reviewing case report forms and communicating with clinical trial investigators. Ultimately, the monitor's job is to ensure clinical trial sites maintain compliance with the study's protocol, the rights and safety of the patient are protected and the reported study data are accurate, complete, and verifiable.

Things You'll Need

• Clinical trial protocol
• Site monitoring plan

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Instructions

• 1

  Review the clinical trial protocol provided by the company sponsoring the research.

• 2

  Determine the frequency and amount of monitoring required for the study. This is based upon several factors such as the study's complexity, disease state, number of subjects enrolled, site's performance and experience and the rate of enrollment into the study. The company sponsoring the study may also have guidelines that must be followed for monitoring.

• 3

  Begin visiting the clinical trial site after the first subjects are enrolled in the study. Ensure protocol procedures are being followed and that the site staff understand all applicable procedures.

• 4

  Complete the site monitoring report provided by the sponsor for each visit. Verify and complete all items listed in the report

• 5

  Submit the monitoring report to the clinical trial sponsor and the appropriate regulatory authorities. Ensure any issues that were observed during the monitoring inspection are addressed in conjunction with the sponsoring company. This will ensure the trial progresses according to the applicable guidelines.