In arandomized, double-blind, placebo-controlled study, if statistical analysis shows that theplacebo appears to outperform the investigational product, a likely cause is adata management or coding error, particularly intreatment code entry or mapping.
According to theGCDMP (Chapter: Database Design and Build), treatment assignment data — typically stored in randomization or code-break files — must beaccurately integratedinto the clinical database. Any mismatch between randomization codes, subject identifiers, or treatment arms can lead to incorrect grouping during analysis, producing false conclusions such as placebo superiority.
The Data Manager should initiate aroot cause reviewof randomization data integration and treatment mapping. The placebo is never designed to have active medicinal effects (option A). Option D is incorrect because the described scenario implies a data inconsistency, not true efficacy differences. Proper verification of randomization coding and reconciliation between data management and statistical programming systems are essential.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Design and Build, Section 6.1 – Randomization and Treatment Code Management
ICH E6 (R2) GCP, Section 5.5.3 – Data Verification and Coding Accuracy
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Data Mapping and Validation Requirements
