Procedure for Randomization and Masking in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the randomization and blinding processes in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the design, conduct, and analysis of BA and BE studies, including Principal Investigators, Study Coordinators, Clinical Research Associates, and Data Managers.

Responsibilities

• The Principal Investigator (PI) or Study Director is responsible for overseeing the randomization and blinding processes and ensuring their integrity throughout the study.
• The Study Team is responsible for implementing the randomization and blinding procedures according to the study protocol and regulatory requirements.
• The Data Management team is responsible for maintaining the randomization code and ensuring that blinding is maintained during data collection, entry, and analysis.

Procedure

1. Develop a randomization plan detailing the allocation of participants to treatment groups, including the method of random sequence generation and allocation concealment.
2. Implement the randomization plan using appropriate techniques such as computer-generated randomization or pre-prepared randomization lists.
3. Ensure that the randomization code is securely stored and accessible only to authorized personnel, such as the Data Management team.
4. Implement blinding procedures to maintain participant, investigator, and assessor blinding throughout the study.
5. Use placebo or matched control treatments as