Documenting Due Diligence for Audits
In the increasingly outsourced landscape of clinical research, vendor qualification and oversight have become core elements of sponsor responsibility. However, the effectiveness of vendor oversight does not end with conducting audits or risk assessments—it is ultimately measured by how well due diligence activities are documented. Documentation is the evidence that sponsors exercised oversight, applied risk-based evaluations, and ensured vendor compliance with regulatory requirements. For regulators such as the FDA, EMA, and MHRA, undocumented due diligence is considered equivalent to due diligence not being performed. Therefore, documentation is not merely an administrative step but a compliance obligation and a safeguard for data integrity and patient safety.
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