When adverse events (AEs) are discovered after adatabase lock, the appropriate first step is toevaluate the impactof the missing data on theintegrity, safety analysis, and regulatory validityof the study results.

According toGCDMP (Chapter: Data Quality Assurance and Control), any post-lock data discovery requires aroot cause assessment and impact analysisbefore deciding whether to unlock the database. The key question is whether the missing AEs:

Affectprimary safety endpoints,

Introducebiasin safety reporting, or

Alterefficacy conclusions.

Based on the assessment, the Data Management and Biostatistics teams determine if unlocking and correction are justified. Simply entering data immediately (A) or repeating checks (D) without analysis may violate data control procedures.

Hence,option Bis correct — the first step is to assess theimpact on data validity and analysis.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Data Quality Assurance and Control, Section 5.5 – Post-Lock Findings and Impact Assessment

ICH E6(R2) GCP, Section 5.1.1 – Quality Management and Risk Assessment

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.5 – Post-Lock Data Management