Standard Operating Procedure for Randomization and Participant Allocation

Purpose

This SOP outlines the procedures for randomization and allocation in clinical trials and clinical studies. The goal is to ensure that participants are allocated to study arms or treatment groups in a fair and unbiased manner, thereby minimizing bias and enhancing the reliability of study results.

Scope

This SOP applies to all personnel involved in randomization and allocation procedures in clinical trials and clinical studies, including principal investigators, clinical research coordinators, study sponsors, and data management teams.

Responsibilities

• Principal Investigator (PI): Ensures randomization and allocation processes comply with study protocols and regulatory requirements.
• Clinical Research Coordinators: Implement randomization and allocation procedures at the site level, ensuring proper documentation.
• Data Management Team: Manages the randomization process and ensures data integrity and security.
• Study Sponsors: Provide the necessary resources and support for randomization and allocation processes.

Procedure

• Randomization Planning:
  • Develop a randomization plan in accordance with the study protocol, specifying the randomization method and procedure.
  • Define the randomization scheme (e.g., simple, blocked, stratified) based on study design and objectives.
• Participant Screening and Eligibility:
  • Screen participants for eligibility according to the study protocol and inclusion/exclusion criteria.
  • Ensure eligible participants have provided informed consent before proceeding with randomization.
• Randomization and Allocation:
  • Randomize eligible participants using the predefined randomization plan.
  • Allocate participants to study arms or treatment groups based on the randomization results.
  • Document the randomization and allocation process in the participant’s case report form (CRF) and study records.
• Blinding (if applicable):
  • If the study is blinded, maintain blinding throughout the study, including participant and investigator blinding.
  • Ensure procedures are in place to protect the integrity of the blinding process.
• Data Management:
  • Record randomization and allocation data in a secure and controlled manner.
  • Maintain confidentiality and privacy of participant information at all times.
• Monitoring and Quality Control:
  • Monitor the randomization and allocation process to ensure compliance with the study protocol.
  • Conduct regular quality control checks to verify the accuracy of randomization data.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRF: Case Report Form

Documents

• Randomization plan and scheme
• Randomization and allocation logs
• Participant case report forms (CRFs)
• Monitoring and quality control reports

References

• Institutional policies for randomization and allocation
• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Study protocols and investigator brochures

SOP Version

Version: 1.0