Which term describes the process of assigning trial subjects to treatment or control groups using chance to reduce bias?

Which term describes the process of assigning trial subjects to treatment or control groups using chance to reduce bias?

• A. Randomization
• B. Quality Control
• C. Source Documents
• D. Regulatory Authorities

Answer: (A)

Randomization is the process of assigning trial subjects to treatment or control groups by chance to prevent bias. By using chance to allocate participants, groups become comparable on both known and unknown factors, so differences in outcomes are more likely due to the intervention rather than preexisting differences. In practice, this can involve a computer-generated random sequence and allocation concealment to keep assignments unpredictable, maintaining the study’s internal validity. This is different from quality control (ensuring procedures meet standards), source documents (the original data records), or regulatory authorities (bodies that oversee trial approvals and conduct).

Randomization is the process of assigning trial subjects to treatment or control groups by chance to prevent bias. By using chance to allocate participants, groups become comparable on both known and unknown factors, so differences in outcomes are more likely due to the intervention rather than preexisting differences. In practice, this can involve a computer-generated random sequence and allocation concealment to keep assignments unpredictable, maintaining the study’s internal validity. This is different from quality control (ensuring procedures meet standards), source documents (the original data records), or regulatory authorities (bodies that oversee trial approvals and conduct).