SOCRA CCRP Practice Exam

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

  1. Withdrawal of IRB approval only

  2. Recall and device disposition only

  3. Withdrawal of FDA approval only

  4. All listed incidences

The correct answer is: 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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