Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

Question: 1 / 400

What must be documented if a deviation was needed to eliminate a hazard?

All subject signatures

The purpose of initial protocol approval

The deviation and rationale submitted to the sponsor

Documentation of any deviation necessitated to eliminate a hazard must include the deviation itself and the rationale submitted to the sponsor. This is essential to maintain accountability and ensure that all parties involved in the clinical trial are aware of the changes made to the protocol. By documenting the specific deviation and the reasoning behind it, the integrity of the trial is preserved, and it allows for proper oversight and assessment by regulatory bodies and sponsors.

Ensuring that the rationale is clearly communicated emphasizes the importance of safety and highlights the actions taken to mitigate risks, which is a critical aspect of clinical research. Such documentation forms part of the trial's overall compliance with regulatory guidelines and facilitates transparency in the management of participant safety.

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The financial impact of the deviation

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