Protocol for Unmasking Treatment Allocation in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the handling of unblinding procedures in Bioavailability (BA) and Bioequivalence (BE) studies, ensuring appropriate disclosure of treatment allocation while maintaining study integrity and participant confidentiality.

Scope

This SOP applies to all study personnel involved in the unblinding process, including Investigators, Study Coordinators, Pharmacists, and Data Managers.

Responsibilities

• The Investigator is responsible for overseeing the unblinding process, ensuring compliance with study protocols and regulatory requirements, and safeguarding participant confidentiality.
• The Study Coordinator is responsible for facilitating the unblinding process, coordinating with the pharmacy or designated unblinding personnel, and documenting unblinding events.
• The Pharmacist or designated unblinding personnel is responsible for disclosing treatment allocation to Investigators or authorized personnel as per study protocol, ensuring accurate and timely unblinding while maintaining participant confidentiality.
• The Data Manager is responsible for recording unblinding events, updating study databases with unblinded information, and ensuring data integrity and confidentiality.

Procedure

1. Establish procedures for handling unblinding requests, including criteria for permissible unblinding events, designated unblinding personnel, and documentation requirements.
2. Ensure that unblinding procedures are only initiated when deemed necessary for participant safety, ethical considerations, or data integrity, as specified in the study protocol or by the Investigator.
3. Designate qualified personnel, such as a pharmacist or unblinding coordinator, to handle unblinding requests and disclose treatment allocation to Investigators or authorized personnel in a confidential manner.
4. Require Investigators or authorized personnel to submit formal unblinding requests, providing justification and supporting documentation, to the designated unblinding personnel for review and approval.
5. Verify the legitimacy of unblinding requests and the identity of requesting personnel before disclosing treatment allocation information, ensuring that unblinding events are documented and logged for audit trail purposes.
6. Disclose treatment allocation to Investigators or authorized personnel in a controlled manner, maintaining participant confidentiality and ensuring that unblinded information is not disclosed to study participants or other unauthorized individuals.
7. Document all unblinding events, including the rationale for unblinding, individuals involved, date and time of unblinding, and any actions taken as a result of unblinding, in unblinding logs or case report forms (CRFs).
8. Update study databases with unblinded information as necessary, ensuring that unblinded data are appropriately coded, labeled, and segregated from blinded data to prevent bias during data analysis.
9. Monitor and report unblinding events as part of study progress reports, safety updates, or regulatory submissions, ensuring transparency and accountability in the unblinding process.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRF – Case Report Form

Documents

• Unblinding Request Form
• Unblinding Log
• Study Protocol
• Regulatory Guidelines

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for handling unblinding procedures in clinical research.

SOP Version

Version 1.0