Good Clinical Practice (GCP) Practice Exam

Which of the following terms is associated with the initiation and management of a clinical trial?

1. Control group

2. Quality assurance

3. Sponsor

4. Source data

The correct answer is: Sponsor

The term associated with the initiation and management of a clinical trial is "Sponsor." The sponsor is the person, company, institution, or organization that takes responsibility for initiating, managing, and financing the clinical trial. This role is crucial in ensuring that the trial is conducted according to GCP guidelines, regulatory requirements, and ethical standards. Sponsors develop the study protocol, oversee the trial's execution, and are involved in the analysis and interpretation of the data collected during the trial. The other terms, while relevant to clinical trials, do not specifically relate to the initiation and management of a trial. For instance, a control group refers to the group of participants in a clinical trial that does not receive the experimental treatment, used for comparative purposes. Quality assurance involves systematic processes to ensure all aspects of a study meet specified standards and requirements, playing a role in the overall management but not directly linked to initiation. Source data refers to original records or documentation that provide evidence of the occurrence of clinical trial-related activities, which is important for data integrity but not indicative of who initiates or manages the trial.