Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

After how many years should trial records be archived post-marketing approval?

1. 5 years

2. 3 years

3. 2 years

4. 1 year

The correct answer is: 2 years

The correct duration for archiving trial records post-marketing approval is typically two years. This timeframe is established by regulatory guidelines that mandate the preservation of clinical trial documentation to ensure ongoing availability for review and compliance purposes. Although some organizations may retain records for longer periods, the two-year mark serves as a minimum requirement that aligns with regulatory standards. This allows for sufficient accessibility in case of audits, inspections, or any post-marketing surveillance activities that may be necessary to evaluate the ongoing safety and efficacy of the drug. While options that suggest shorter archival periods may appear attractive for reducing resource burdens, they do not meet the regulatory expectations for maintaining comprehensive records that can support the drug's profile and safety narrative in the years following its approval.