Certified Clinical Research Coordinator (CCRC) Practice Exam

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Study for the Certified Clinical Research Coordinator exam. Engage with flashcards and multiple choice questions, complete with hints and explanations. Prepare for your exam day!

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Which type of amendment must be approved by the IRB prior to implementation?

  1. Amendment that reduces study duration

  2. Amendment that increases recruitment rates

  3. Amendment that increases the risks to subjects

  4. Amendment that changes the data analysis plan

The correct answer is: Amendment that increases the risks to subjects

The amendment that increases the risks to subjects must be approved by the Institutional Review Board (IRB) prior to implementation because it directly impacts participant safety and ethical considerations in the study. The primary role of the IRB is to ensure the rights and welfare of participants are protected, which is especially critical when any changes made to the study protocol could potentially elevate the risks associated with participation. When an amendment introduces higher risks, the IRB needs to carefully evaluate the justification for the increased risk, look at how it may affect informed consent, and ensure that the potential benefits outweigh the risks. This process is essential to maintain ethical standards in clinical research and to ensure compliance with regulatory requirements. In contrast, while amendments that reduce study duration, increase recruitment rates, or change the data analysis plan may also require IRB attention depending on the specific study context or institutional policies, they do not inherently raise the same level of concern regarding participant safety and ethical implications as an amendment that increases risks. Therefore, such amendments may not necessitate IRB approval before being implemented.