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

Question: 1 / 400

Which incidences must sponsors report to the FDA and/or investigators?

Withdrawal of IRB approval only

Recall and device disposition only

Withdrawal of FDA approval only

All listed incidences

Sponsors are obligated to report all listed incidences to the FDA and/or investigators. This includes the withdrawal of IRB approval, recall and device disposition, as well as withdrawal of FDA approval. Therefore, options A, B, and C are all incomplete and do not fulfill the reporting requirements. It is crucial for sponsors to report all listed incidences to ensure the safety and effectiveness of the product and protect the participants involved in the trial.

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