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

Question: 1 / 400

Which document should include the dosage administered to the subject?

Investigator's report

Drug accountability form

The drug accountability form is the document that should include the dosage administered to the subject because it is specifically designed to track the receipt, storage, dispensing, and return of investigational drugs. This form provides detailed records of the drug's usage in a clinical trial, ensuring compliance with regulatory standards and allowing for accurate monitoring of the trial's integrity.

The form is essential for confirming that subjects receive the correct dosage according to the study protocol, as well as for maintaining accountability for the investigational product, which is crucial for both trial monitoring and auditing purposes. Tracking dosage is important to assess both the safety and efficacy of the treatment being studied, and the drug accountability form serves as a legal document that supports this tracking.

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Patient’s medical record

Trial completion form

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