Bioequivalence Bioavailability Study

SOP for Randomization and Blinding

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.
See also  SOP for Cross-validation of Bioanalytical Methods

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 necessary to achieve blinding, ensuring that they are indistinguishable from the active treatment.
  6. Monitor adherence to blinding procedures throughout the study and address any breaches or unblinding incidents promptly.
  7. Conduct appropriate blinding integrity checks during data analysis and interpretation to minimize bias.
See also  SOP for Data Entry and Management

Abbreviations

  • SOP – Standard Operating Procedure
  • BA – Bioavailability
  • BE – Bioequivalence
  • PI – Principal Investigator

Documents

  • Randomization Plan
  • Blinding Procedures Manual
  • Blinding Integrity Checks
  • Randomization Code Log

Reference

International Conference on Harmonisation (ICH) E9 Statistical Principles for Clinical Trials.

SOP Version

Version 1.0

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