According to record-keeping requirements, what must be done if no application is filed for a drug?

Keeping records for at least two years after the termination of an investigation is critical in the context of ICH E6 guidelines. This requirement ensures that there is sufficient time to review the data, conduct audits, or respond to any regulatory inquiries that may arise after the investigations have concluded. Retaining these records is essential for accountability and maintaining the integrity of the clinical trial process.

In addition, this period allows for the traceability of data generated during the investigation, which supports regulatory compliance and facilitates the quality assurance processes necessary in clinical research. Records may include essential documentation relevant to the conduct of the trial, such as protocols, reports, and correspondence, providing vital information for future studies or regulatory assessments.

The other options do not align with the requirements set out in the ICH guidelines. For instance, maintaining records indefinitely might lead to challenges in data management and can impose unnecessary burdens on organizations. Conversely, discarding records after one year does not provide enough time for any post-investigation needs to be addressed, and keeping records for only five years exceeds the minimum necessary retention period as specified by the guidelines.