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

According to regulations, how long should essential documents be retained after the last marketing application approval?

1. 1 year

2. 2 years

3. 3 years

4. 5 years

The correct answer is: 2 years

The correct retention period for essential documents after the last marketing application approval is two years. This requirement is established to ensure that all relevant records and documents are maintained long enough to support any necessary audits, regulatory inspections, or reviews that may occur in relation to the authorized marketing application. This retention period aligns with the industry standards that specify that documents must remain accessible for a duration sufficient to address any potential inquiries or requirements that arise from regulatory bodies or stakeholders involved in the process. In the context of clinical trials and drug development, maintaining such records signifies an organization's commitment to compliance and transparency. Retaining documents for a set period also aligns with regulatory good practices, allowing for adequate assessments of safety and efficacy based on past studies, should any questions arise post-approval. In summary, the two-year retention period is essential for upholding regulatory and legal standards and ensuring that all documentation is readily available for future reference, thereby supporting ongoing patient safety and effective drug monitoring.