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

Question: 1 / 400

What must be explicitly authorized in writing by the sponsor concerning study products?

Alternative methods of disposition

In clinical research, explicit written authorization from the sponsor is crucial for any alternative methods of disposition concerning study products. This involves how the study products (like drugs or devices) will be handled at the conclusion of the study, including their return, destruction, or other forms of handling. Such authorization ensures compliance with regulatory and ethical standards, safeguards the integrity of the study, and protects both the participants and the research organization from any potential liability.

While changes in study protocol, compensation for subjects, and the selection of study sites also require appropriate oversight and may necessitate approvals, they often undergo a different process for amendments through institutional review boards (IRBs) or regulatory agencies. These processes do not specifically necessitate the same written authorization from sponsors as the management of study products does.

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Changes in study protocol

Compensation for subjects

Selection of study sites

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