What is the minimum record retention time required after the completion of an investigation?

What is the minimum record retention time required after the completion of an investigation?

• A. One year
• B. Two years
• C. Three years
• D. As needed

Answer: (B)

The minimum record retention time required after the completion of an investigation is outlined by regulations and guidelines that ensure the integrity and availability of data related to clinical trials. For investigations that fall under Good Clinical Practice guidelines, the standard retention period is typically two years following the last approval of a marketing application in a particular region. This period allows for adequate time to resolve any potential queries or concerns regarding the data or the investigation, and it aligns with regulatory expectations for maintaining records that could be necessary for auditing or compliance reviews. In addition, retaining records for this duration contributes to the overall scientific and ethical conduct of clinical research. After the two-year retention period, organizations often determine whether a longer retention time is necessary based on their policies, specific regulatory requirements for their field, or the nature of the data involved. While some might suggest shorter retention times or the idea of retaining records only as needed, data integrity and regulatory compliance drive the more extended requirement in order to ensure that records are available for review and that the research findings remain transparent and accountable.

The minimum record retention time required after the completion of an investigation is outlined by regulations and guidelines that ensure the integrity and availability of data related to clinical trials. For investigations that fall under Good Clinical Practice guidelines, the standard retention period is typically two years following the last approval of a marketing application in a particular region. This period allows for adequate time to resolve any potential queries or concerns regarding the data or the investigation, and it aligns with regulatory expectations for maintaining records that could be necessary for auditing or compliance reviews.

In addition, retaining records for this duration contributes to the overall scientific and ethical conduct of clinical research. After the two-year retention period, organizations often determine whether a longer retention time is necessary based on their policies, specific regulatory requirements for their field, or the nature of the data involved.

While some might suggest shorter retention times or the idea of retaining records only as needed, data integrity and regulatory compliance drive the more extended requirement in order to ensure that records are available for review and that the research findings remain transparent and accountable.