Which document records the method for randomization of the trial population?

Which document records the method for randomization of the trial population?

• A. Shipping Records for Investigational Products and Trial-Related Materials
• B. Certificates of Analysis of Investigational Products Shipped
• C. Decoding Procedures for Blinded Trials
• D. Master Randomization List

Answer: (D)

In randomized trials, the record that defines how participants are assigned to treatment groups and the exact sequence is the master randomization list. It contains the randomization scheme, block sizes, stratification factors, and the allocation sequence, and is kept secure to maintain blinding. This document is the authoritative record of how the trial population is randomized. Shipping records and certificates of analysis pertain to supply and quality of investigational products, not to how participants are allocated. Decoding procedures describe unblinding steps, not the method used to randomize participants.

In randomized trials, the record that defines how participants are assigned to treatment groups and the exact sequence is the master randomization list. It contains the randomization scheme, block sizes, stratification factors, and the allocation sequence, and is kept secure to maintain blinding. This document is the authoritative record of how the trial population is randomized. Shipping records and certificates of analysis pertain to supply and quality of investigational products, not to how participants are allocated. Decoding procedures describe unblinding steps, not the method used to randomize participants.