What recruitment capability must the investigator demonstrate for the trial?

• A. The investigator should be able to recruit the required number of suitable subjects within the agreed recruitment period.
• B. The investigator must recruit as many subjects as possible regardless of the recruitment period.
• C. Recruitment capability is optional for the trial.
• D. Recruitment performance is determined after enrollment begins.

Answer: (A)

The key idea is that an investigator must show the ability to enroll the required number of eligible and consenting subjects within the agreed recruitment period. This ensures the study is feasible, can hit its timelines, and maintains data integrity and subject safety. A realistic recruitment plan demonstrates access to suitable participants and the resources to screen and enroll them efficiently, aligning with the trial’s design and regulatory expectations. It wouldn’t be acceptable to aim for as many enrollments as possible without regard to the timeframe, treat recruitment as optional, or judge performance only after enrollment has begun, because those approaches jeopardize study power, timelines, and ethical oversight.