What should a research compliance professional instruct a study coordinator regarding payment for recruitment in a clinical trial?

The guidance provided to the study coordinator regarding payment for recruitment in a clinical trial centers around ensuring that the payment structure aligns with compliance regulations and accurately reflects the services provided. Instructing the study coordinator to amend the Clinical Research Agreement (CRA) to specify the work performed in exchange for payments is critical because it establishes a clear and legitimate framework for compensation. This helps document that the payments correspond directly to the recruitment activities conducted, thereby supporting transparency and adherence to regulatory standards.

By detailing the services provided within the CRA, the study ensures that the compensation is for legitimate work rather than for enrolling participants improperly, which could lead to potential conflicts of interest or ethical violations. It is essential for compliance professionals to maintain a clear record of all activities and payments in research settings, as this demonstrates adherence to regulations and protects both the study sponsors and participants involved.

While other responses touch on potential concerns related to conflicts of interest or applicable regulations, they do not adequately address the practical step needed to align the payment with the services rendered. This clarity is paramount in clinical trial operations to maintain ethical standards and compliance with regulatory bodies.