A Clinical Data Manager reads a protocol for a clinical trial to test the efficacy...

When theprimary efficacy endpointin a clinical trial is3-month survival, the key data element required is thedeath date. This is because the survival endpoint is determined by calculating whether the subject lived or died within a defined time frame from study enrollment or randomization.

According to theGCDMP (Chapter: Data Management Planning and Study Start-up), the Clinical Data Manager (CDM) must identify and ensure the capture of allcritical data elementsnecessary to evaluate the study endpoints. For time-to-event analyses (e.g., survival studies), accurateevent dates (death date)are essential for endpoint derivation and statistical analysis.

Other data elements such as cause of death or date of autopsy (options B and C) may support secondary analyses or safety reviews but are not necessary to determine the survival endpoint itself. Similarly,birth date(option D) contributes to demographic data but is unrelated to the primary efficacy outcome.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Management Planning and Study Start-up, Section 4.4 – Critical Data Identification for Endpoints

ICH E9 – Statistical Principles for Clinical Trials, Section 2.2.3 – Time-to-Event Data Considerations

FDA Guidance for Industry: Clinical Trial Endpoints for Drug Development