How long must IRB records be retained after the completion of a trial according to ICH and FDA?

How long must IRB records be retained after the completion of a trial according to ICH and FDA?

• A. Two years
• B. Three years
• C. Five years
• D. Indefinitely

Answer: (B)

The requirement for retaining Institutional Review Board (IRB) records after the completion of a clinical trial is set forth in both ICH guidelines and FDA regulations, which specify a retention period of three years. This timeframe begins from the date the trial is completed, ensuring that all documentation pertinent to the trial's ethical oversight, protocol amendments, and informed consent processes is preserved for review and accountability. Retention of records for three years aligns with the need for maintaining adequate documentation in case of audits, inspections, or inquiries related to the trial. This facilitates transparency and supports the integrity of the research process, allowing for potential future reference in disputes or evaluations of the trial's conduct. In contrast, other retention periods—such as two, five, or indefinite—do not meet the specific regulatory requirements established by the ICH and FDA for clinical trials. A period of two years falls short of the required timeframe, while five years exceeds it unnecessarily for the purpose of IRB documentation. Retaining records indefinitely is also impractical and not mandated. Therefore, the three-year retention period is the standard established for ensuring proper oversight of clinical research activities.

The requirement for retaining Institutional Review Board (IRB) records after the completion of a clinical trial is set forth in both ICH guidelines and FDA regulations, which specify a retention period of three years. This timeframe begins from the date the trial is completed, ensuring that all documentation pertinent to the trial's ethical oversight, protocol amendments, and informed consent processes is preserved for review and accountability.

Retention of records for three years aligns with the need for maintaining adequate documentation in case of audits, inspections, or inquiries related to the trial. This facilitates transparency and supports the integrity of the research process, allowing for potential future reference in disputes or evaluations of the trial's conduct.

In contrast, other retention periods—such as two, five, or indefinite—do not meet the specific regulatory requirements established by the ICH and FDA for clinical trials. A period of two years falls short of the required timeframe, while five years exceeds it unnecessarily for the purpose of IRB documentation. Retaining records indefinitely is also impractical and not mandated. Therefore, the three-year retention period is the standard established for ensuring proper oversight of clinical research activities.