Good Clinical Practice (GCP) Practice Exam

What is the main responsibility of a subinvestigator in a clinical trial?

1. To conduct trial-related procedures under the investigator's supervision

2. To manage trial finances and budgets

3. To recruit all subjects without oversight

4. To write the final report of the trial

The correct answer is: To conduct trial-related procedures under the investigator's supervision

The main responsibility of a subinvestigator in a clinical trial is to conduct trial-related procedures under the investigator's supervision. This role is crucial as subinvestigators assist the principal investigator in the management of the trial, ensuring that all trial procedures are executed according to the protocol, Good Clinical Practice (GCP) guidelines, and regulatory requirements. Subinvestigators may perform tasks such as enrolling participants, administering study interventions, collecting data, and monitoring for adverse events, all while adhering to the oversight provided by the principal investigator. This collaboration ensures comprehensive care for trial subjects and helps maintain the integrity and quality of the study. The other options do not accurately reflect the primary role of a subinvestigator within the context of clinical trials. For instance, managing trial finances and budgets typically falls under the domain of the study sponsor or site management, not the subinvestigator. Similarly, while recruiting participants is part of the process, it is done under the established protocols and with oversight, not independently or without guidance. Writing the final trial report is generally the responsibility of the principal investigator, who synthesizes the findings from the entire team involved in the study.