Good Clinical Practice (GCP) Practice Exam

Question: 1 / 400

Define "Case Report Form" (CRF).

A document to collect pricing data of drugs

A form designed to collect all protocol-defined data

A Case Report Form (CRF) is a key document in clinical trials, specifically designed to collect all protocol-defined data that is required for the study. The CRF captures every pertinent piece of information about each participant's experience during the trial, including demographic details, medical history, laboratory test results, and specific data points defined by the study protocol. This systematic collection of data ensures that researchers can analyze the results accurately and comply with regulatory standards.

The importance of the CRF lies in its role in maintaining data integrity and consistency throughout the clinical trial process. By providing a structured format for data entry, it facilitates the efficient collection of critical information that will ultimately inform the trial's outcomes. The accuracy and completeness of the data recorded in the CRF are essential for the validity of the clinical research findings.

Other choices do not align with the defined purpose of a CRF. For example, collecting pricing data of drugs is not within the scope of what a CRF entails. Similarly, general feedback forms for participants and surveys conducted after the completion of clinical trials serve different purposes, focusing on participant experiences or outcomes rather than the systematic collection of protocol-defined clinical data.

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A general feedback form for participants

A survey used after the completion of clinical trials

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