When an audit identifiesmissing or undocumented training, the most appropriate and compliant response is toidentify the root causeof the issue andimplement corrective and preventive actions (CAPA)to ensure that similar findings do not recur.
According toGood Clinical Data Management Practices (GCDMP, Chapter: Quality Management and Auditing), effective quality systems require root cause analysis (RCA) for all audit findings. The process involves:
Investigating why the documentation gap occurred (e.g., poor tracking, outdated SOP, or lack of oversight).
Correcting the immediate issue (e.g., ensuring the developers complete or document training).
Updating processes, training systems, or oversight mechanisms to prevent recurrence.
While sending the two developers to training (D) addresses thesymptom, it does not resolve thesystemic issueidentified by the audit. Options B and C are non-compliant and do not address quality system improvement.
Therefore,option A (Identify the root cause and improve the process)is the best and CCDM-compliant response.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Quality Management and Auditing, Section 6.2 – Corrective and Preventive Actions (CAPA)
ICH E6(R2) GCP, Section 5.1.1 – Quality Management and Continuous Process Improvement
FDA 21 CFR Part 820.100 – Corrective and Preventive Action (CAPA) Requirements
