Protocol for Ending BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the termination of Bioavailability (BA) and Bioequivalence (BE) studies, ensuring proper closure of study activities, data collection, and documentation in accordance with regulatory requirements and study protocols.

Scope

This SOP applies to all study personnel involved in the conduct and management of BA/BE studies, including Investigators, Study Coordinators, Data Managers, and Regulatory Affairs Personnel.

Responsibilities

• The Investigator is responsible for making the decision to terminate the study based on predefined criteria, ensuring participant safety, and notifying relevant parties in a timely manner.
• The Study Coordinator is responsible for coordinating study termination activities, including notifying study personnel, completing study documentation, and ensuring compliance with regulatory requirements.
• The Data Manager is responsible for ensuring that all study data are collected, documented, and archived appropriately before study termination, and for coordinating data analysis and reporting activities.
• The Regulatory Affairs Personnel is responsible for informing regulatory authorities and sponsors about the decision to terminate the study, providing necessary documentation, and ensuring compliance with regulatory reporting requirements.

Procedure

1. Establish criteria for study termination, including predefined endpoints, safety concerns, regulatory requirements, or sponsor decisions, as outlined in the study protocol.
2. Monitor study progress and safety data throughout the study duration, identifying potential reasons for study termination such as adverse events, lack of efficacy, protocol deviations, or sponsor decisions.
3. Notify relevant study personnel, sponsors, regulatory authorities, and ethics committees about the decision to terminate the study, providing justification, supporting documentation, and proposed termination procedures.
4. Complete all necessary study documentation, including case report forms (CRFs), adverse event reports, protocol deviations, and study logs, ensuring that all data are accurate, complete, and properly annotated.
5. Collect and document any remaining study data, including follow-up assessments, laboratory results, and participant disposition, ensuring that data collection is completed according to study protocols and regulatory requirements.
6. Prepare a final study report summarizing study findings, including safety data, efficacy outcomes, protocol deviations, and participant demographics, and submit the report to sponsors, regulatory authorities, and ethics committees as required.
7. Archive study documents, including study protocols, informed consent forms, regulatory submissions, and data collection tools, in accordance with regulatory requirements and sponsor guidelines, ensuring data integrity and accessibility for future reference or audit purposes.
8. Notify study participants about the decision to terminate the study, providing explanations, support, and follow-up care as needed, and ensure that participant rights and confidentiality are maintained throughout the termination process.
9. Conduct a post-study review to evaluate study conduct, outcomes, and lessons learned, identifying areas for improvement and making recommendations for future studies or research projects.

Abbreviations

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

Documents

• Study Termination Notification
• Final Study Report
• Archived Study Documents
• Post-Study Review Report

Reference

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

SOP Version

Version 1.0