Certified Clinical Research Associate (CCRA) Exam 2025 – 400 Free Practice Questions to Pass the Exam

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What type of information does the FDA require from each investigator and subinvestigator involved in a clinical trial?

Experience in conducting clinical trials

Credentials

The FDA requires documentation of credentials from each investigator and subinvestigator involved in a clinical trial to ensure that they are properly qualified to conduct the research. This requirement is important because it verifies that the individuals overseeing the study have the necessary training, education, and expertise in the relevant field to manage the clinical trial effectively and ethically.

By confirming the credentials, the FDA is also ensuring that the investigators can adhere to Good Clinical Practice (GCP) guidelines, maintain the integrity of the data collected, and protect the rights and welfare of the study participants. Assessing an investigator’s credentials helps establish their ability to responsibly conduct the trial according to regulatory standards, which is crucial for ensuring the reliability of trial results and participant safety.

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Personal identification

Compliance history

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