What should be done regarding patient compliance in a trial?

• A. Compliance is optional to report.
• B. Compliance is determined solely by patient memory.
• C. Compliance methods should be specified and actual usage documented.
• D. Compliance relates only to attendance at visits.

Answer: (C)

Compliance is about how well participants follow the protocol, including taking the study drug as prescribed, performing required procedures, and attending visits within specified windows. The best practice is to specify in the protocol how adherence will be measured and to document actual usage in source documents and the case report form. This ensures data integrity, supports correct interpretation of results, and enables proper safety monitoring and regulatory oversight. Compliance data aren’t optional; use methods like patient diaries, electronic monitoring, pill counts, drug accountability, and visit verification to quantify adherence. Relying on patient memory alone is insufficient, and simply noting attendance at visits doesn’t capture true adherence to dosing or procedures.