Which document specifies the master randomization list?

Which document specifies the master randomization list?

• A. Shipping Records for Investigational Products and Trial-Related Materials
• B. Master Randomization List
• C. Decoding Procedures for Blinded Trials
• D. Trial Initiation Monitoring Report

Answer: (B)

The allocation sequence that determines which participant receives which treatment is defined in the master randomization list. This document lays out the predefined randomization plan (including sequence, block sizes, and any stratification) and assigns each enrolled participant to a treatment arm according to that plan. It is typically created by the statistician or sponsor and kept securely with access limited to unblinded personnel to preserve blinding for the rest of the study. While other documents handle different tasks—decoding procedures describe how and when unblinding may occur, shipping records track investigational product distribution, and trial initiation monitoring reports cover start-up activities—they do not specify the assignment sequence. Therefore, the document that specifies the master randomization list is the Master Randomization List itself.

The allocation sequence that determines which participant receives which treatment is defined in the master randomization list. This document lays out the predefined randomization plan (including sequence, block sizes, and any stratification) and assigns each enrolled participant to a treatment arm according to that plan. It is typically created by the statistician or sponsor and kept securely with access limited to unblinded personnel to preserve blinding for the rest of the study. While other documents handle different tasks—decoding procedures describe how and when unblinding may occur, shipping records track investigational product distribution, and trial initiation monitoring reports cover start-up activities—they do not specify the assignment sequence. Therefore, the document that specifies the master randomization list is the Master Randomization List itself.