SOCRA CCRP Practice Exam

Sponsors should keep study records for device trials for at least 2 years after the investigation is terminated or completed. This option ensures that all necessary information is still available for any potential follow-up or audits. Options A, C, and D do not provide a sufficient time frame to maintain study records. Option A may not allow enough time for potential follow-up or audits, as the approval process for a PMA can take several years. Option C only applies to the record-keeping requirements for a launched product, not the duration of a study. Option D only applies to the last product shipped, not the entire duration of the study.