Which statement best describes the purpose of maintaining randomization codes and code-breaking procedures?

• A. Maintaining blinding and enabling controlled unblinding
• B. Disclosing codes to participants
• C. Immediate unblinding for all participants
• D. Not using any codes

Answer: (A)

Maintaining randomization codes and code-breaking procedures protects the integrity of the trial by preserving blinding. Blinding minimizes bias in treatment effects, outcome assessment, and data interpretation. Code-breaking procedures ensure that unblinding occurs only when necessary for participant safety or essential trial operations, and that each unblinding is documented and controlled. Disclosing codes to participants would destroy blinding and introduce bias. Unbinding all participants immediately or not using any codes would undermine the study design and compromise randomization.