Question

GCP guidelines define essential documents for which phase(s) of a clinical trial?

O A. Before the trial starts
O B. During the clinical trial
O C. After the clinical trial closes
algloses
O D. All of the above.

Answer 1

The GCP guidelines define essential documents for all phases of a clinical trial: before the trial starts, during the clinical trial, and after the clinical trial closes.

Step-by-step explanation:

The GCP (Good Clinical Practice) guidelines define essential documents for all phases of a clinical trial, which includes:

• Before the trial starts: During this phase, essential documents such as the protocol, investigator's brochure, and informed consent forms are developed and finalized.
• During the clinical trial: Essential documents include subject records, case report forms, and monitoring reports, among others. These documents are crucial for monitoring and ensuring the integrity of the trial.
• After the clinical trial closes: Essential documents in this phase include final study reports, audit reports, and regulatory submissions.

Learn more about Essential documents in clinical trials