Noncompliance in Clinical Trials Standard Practice Guideline

Strategies to embed compliance in your team operations, optimize communication with participants and address study deviations to safeguard research integrity

What is this resource?

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.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research.