The sponsor discontinued the clinical development of an investigational product.

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).