What must be maintained for the randomization process and potential code-breaking?

• A. Blinding status
• B. Maintenance of randomization codes and procedures for breaking codes
• C. Labeling procedures
• D. Data security measures

Answer: (B)

Keeping the randomization codes and the procedures for breaking them is essential because it preserves the ability to reveal a participant’s assigned treatment in a controlled, legitimate way while maintaining the integrity of the study. The codes link each participant to their treatment, and having secure, defined unblinding procedures ensures that unblinding happens only when allowed (for safety reasons or required analyses), with a clear audit trail. This supports maintaining blinding during the trial while providing a safe path to reveal assignments when needed. Blinding status alone doesn’t specify how to reveal the assignment, labeling procedures pertain to materials, and data security, while important, is broader and not the specific focus on maintaining and potentially breaking the randomization code.