According to ICH E6, how long must essential documents be retained by the sponsor?

According to ICH E6, how long must essential documents be retained by the sponsor?

• A. At least five years after the trial ends
• B. Until the next trial begins
• C. Until two years after the last approval of a marketing application
• D. Documents do not need to be retained

Answer: (C)

The requirement to retain essential documents for a specified duration is crucial to ensure compliance with regulatory standards and facilitate the traceability of clinical trial data. Retaining documents for two years after the last approval of a marketing application aligns with the regulatory framework established by ICH E6, which emphasizes the importance of maintaining comprehensive records for verification and reference in case of future inquiries or audits. This retention period allows for adequate oversight and accountability, ensuring that the data collected during clinical trials remains accessible for quality assurance and regulatory review. This is essential for upholding the integrity of the research and contributing to public health safety. In the context of the other options, retaining documents for at least five years after the trial ends does not align precisely with ICH E6 requirements, as the focus is specifically on the timeline following the last marketing application approval. Retaining documents until the next trial begins could lead to a risk of incomplete records if there is a delay or gap between trials. The assertion that documents do not need to be retained is contrary to the established standards that mandate documentation retention for accountability and regulatory purposes.

The requirement to retain essential documents for a specified duration is crucial to ensure compliance with regulatory standards and facilitate the traceability of clinical trial data. Retaining documents for two years after the last approval of a marketing application aligns with the regulatory framework established by ICH E6, which emphasizes the importance of maintaining comprehensive records for verification and reference in case of future inquiries or audits.

This retention period allows for adequate oversight and accountability, ensuring that the data collected during clinical trials remains accessible for quality assurance and regulatory review. This is essential for upholding the integrity of the research and contributing to public health safety.

In the context of the other options, retaining documents for at least five years after the trial ends does not align precisely with ICH E6 requirements, as the focus is specifically on the timeline following the last marketing application approval. Retaining documents until the next trial begins could lead to a risk of incomplete records if there is a delay or gap between trials. The assertion that documents do not need to be retained is contrary to the established standards that mandate documentation retention for accountability and regulatory purposes.