Standard Operating Procedure for Participant and Investigator Masking

Purpose

This SOP outlines the procedures for blinding and masking in clinical trials and clinical studies. The goal is to maintain objectivity and integrity in the study by preventing bias and ensuring that participants and study personnel are unaware of the assigned interventions.

Scope

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

Responsibilities

Principal Investigator (PI): Ensures compliance with the blinding and masking protocol and addresses any potential unblinding issues.
Clinical Research Coordinators: Implement blinding and masking procedures at the site level and monitor compliance.
Data Management Team: Manages the allocation and data handling processes to maintain blinding and data integrity.
Study Sponsors: Provide resources and support for the blinding and masking processes.

Procedure

Blinding Plan Development:
- Develop a blinding plan according to the study protocol, specifying the blinding or masking method.
- Determine the level of blinding (single, double, or triple) based on study design and objectives.
Implementation of Blinding and Masking:
- Implement the blinding or masking plan throughout the study, ensuring consistency in all aspects of the study.
- Provide training to study personnel on blinding and masking procedures to ensure adherence.
Monitoring and Maintaining Blinding:
- Monitor the

study regularly to ensure blinding or masking is maintained throughout.

Take appropriate actions to address any deviations from the blinding plan.

Unblinding Procedures:

Develop unblinding procedures for emergency situations and provide training to relevant personnel.
Document unblinding events, including the reason and the impact on study integrity.

Data Handling and Management:

Manage and handle data securely to maintain blinding and confidentiality of treatment assignments.
Limit access to randomization codes and participant information to authorized personnel only.

Abbreviations Used

SOP: Standard Operating Procedure
PI: Principal Investigator

Documents

Blinding and masking plans and strategies
Training materials for study personnel
Monitoring and deviation logs
Unblinding logs and documentation

References

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

SOP Version

Version: 1.0