SOCRA CCRP Practice Exam

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What is the time period within which a sponsor must submit a final report after completion/termination of a SR device trial?

  1. Within 3 months

  2. Within 6 months

  3. Within 9 months

  4. Within 12 months

The correct answer is: Within 6 months

After completion or termination of a SR device trial, a sponsor must submit a final report within 6 months. This is because submitting the report at a later date could potentially delay the device from reaching the market, as the final report is crucial in the evaluation and approval process. Option A, within 3 months, is incorrect because it is too early for a sponsor to have conducted a proper analysis and preparation of the report. Option C, within 9 months, and option D, within 12 months, are incorrect because they both exceed the allotted time period for submitting the final report. Waiting too long to submit the report could also potentially delay the device from becoming available to the public. Therefore, the best and most appropriate option is B, within 6 months, as it allows for a reasonable amount of time for the proper analysis, preparation, and submission of the final report for

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