Good Clinical Practice (GCP) Practice Exam

What is the main function of an Independent Data-Monitoring Committee (IDMC)?

1. To conduct the clinical trial

2. To provide legal oversight

3. To assess trial progress and safety data

4. To finalize study conclusions

The correct answer is: To assess trial progress and safety data

The primary function of an Independent Data-Monitoring Committee (IDMC) is to assess trial progress and safety data. This committee plays a critical role in ensuring the safety of participants and the integrity of the trial results. The IDMC regularly reviews data collected during a clinical trial, particularly safety data, to determine whether the trial should proceed, be modified, or halted. Their independent and objective assessments help protect participants from potential harm and ensure that the trial is conducted ethically and according to predefined standards. The IDMC does not conduct the clinical trial itself, as that responsibility lies with the sponsors and investigators. Additionally, while legal oversight may be part of a regulatory framework, the primary duty of an IDMC is far more focused on data assessment rather than legal aspects. Lastly, while the IDMC may provide insights or recommendations based on their evaluations, they do not finalize study conclusions; those responsibilities fall to the study investigators and sponsors once all data have been analyzed comprehensively after the trial's completion.