Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

Question: 1 / 400

What is the responsibility of investigators regarding the records of investigational products?

Update records weekly

Reconciliation of products

The responsibility of investigators regarding the records of investigational products primarily includes the reconciliation of products. This involves ensuring that all products are accounted for, which is critical for maintaining the integrity of the clinical trial. Reconciliation ensures that the amount of investigational product received, used, and returned matches accurately, thus preventing discrepancies that could affect the study's validity. Proper reconciliation can help in identifying if there have been any product losses or issues related to compliance with the study protocol.

The other choices, while relevant to broader investigational product management, do not capture the core responsibility assigned to investigators in the context of maintaining accurate records. Updating records weekly may be necessary, but it is more of a procedural aspect rather than a defined responsibility. The destruction of expired products and dissemination of records to sponsors may fall under the purview of other roles such as clinical trial administrators or sponsors, rather than being a direct investigator responsibility.

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Destruction of expired products

Dissemination of records to sponsors

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