Noncompliance in Clinical Trials

Overview

In the conduct of single and multi-site clinical trials, it is ultimately the responsibility of the principal investigator to ensure all affiliated research personnel are compliant with the protocol. The principal investigator should also ensure that procedures are in place to document, communicate, and report (as required by institutional, state, and regulatory requirements) non-compliance that involves clinical trial subjects, the research team, sponsors, and clinical trial monitors especially as it relates to the safety and protection of subjects.

Every effort should be made to maintain research subject participation in the clinical trial. To improve compliance, it is important for the research team to regularly evaluate their work processes to ensure they are not contributing to subject non-compliance.

An example of this would be informing subjects early on, that there may be limited time available to schedule clinic visits, run tests, or have procedures done. When subjects are fully aware of potential barriers, they are better able to plan around them, or may choose not to participate in the clinical trial. Addressing potential issues in advance can help to minimize the number of deviations that occur.

Related Resources

University of Michigan Research Ethics & Compliance – Research Human Subjects

HRPP Operations Manual (OM)

Standard Practice Guideline (SPG) Templates for Clinical Trials

 

Downloadable Templates

Noncompliance in Clinical Trials.docx

Questions?

Contact us at MICHR-SPGSupport@umich.edu.

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