SOCRA CCRP Practice Exam 2025 – 400 Free Practice Questions to Pass the Exam

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Question: 1 / 400

For what purpose must IRBs insure that changes in research are not initiated without approval?

To comply with sponsor requests

To adhere to 21 CFR 56 regulations

To ensure ethical standards

To prevent deviations from the protocol

Changes in research must not be initiated without approval to prevent deviations from the protocol. Deviations from the approved protocol can lead to inaccurate or biased results, which can harm the scientific integrity of the study. Additionally, changing research procedures without approval may also violate ethical standards and regulatory requirements, such as those outlined in 21 CFR 56 for the protection of human subjects in research. While complying with sponsor requests and adhering to regulations are important, ensuring ethical standards and preventing deviations from the protocol are the primary reasons for IRBs to require approval before initiating changes in research.

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