Certified Clinical Research Associate (CCRA) Practice Exam

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Prepare for the CCRA Exam with interactive flashcards and multiple choice questions, each offering hints and detailed explanations. Equip yourself with the knowledge you need for certification success!

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Is it true that investigators do not have to maintain records of doses provided to subjects as specified in the protocol?

True
False
Only during early phases
Only for non-critical trials

The correct answer is: False

Maintaining accurate records of doses provided to subjects as specified in the protocol is a critical requirement in clinical research. This is essential for ensuring that the study adheres to its design and that the integrity of the data collected is preserved. Detailed documentation allows for transparency and accountability in how the trial is conducted. Consistent record-keeping also supports the safety monitoring of participants, compliance with regulatory standards, and facilitates accurate reporting of results. If the dosing information is not recorded, it can lead to significant issues in evaluating the effectiveness and safety of the intervention being studied, as well as potential risks to participants. Proper documentation is foundational to good clinical practice (GCP) guidelines and is a necessary component of conducting ethical and scientifically valid research. Therefore, the assertion that investigators do not need to maintain such records is inaccurate, reinforcing the need for comprehensive documentation throughout the study process.