SOCRA Certified Clinical Research Professional (CCRP) CCRP Question # 33 Topic 4 Discussion
CCRP Exam Topic 4 Question 33 Discussion:
Question #: 33
Topic #: 4
The sponsor discontinued the clinical development of an investigational product. In accordance with the ICH GCP Guidance, at least how long should the sponsor maintain all sponsor-specific essential documents?
Retention of essential documents ensures accountability and inspection readiness.
ICH E6(R2) 5.5.12 & 8.1:Sponsors should retain essential documents “until at least2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applicationsor at least 2 years after formal discontinuation of clinical development of the investigational product.”
This standard balances subject protection with practical recordkeeping. Longer durations (B–D) may apply under institutional or national rules, but ICH establishes2 years minimum.
Correct answer:A (2 years).
[References:, ICH E6(R2), §5.5.12, §8.1., ]
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