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
- Establish criteria for study termination, including predefined endpoints, safety concerns, regulatory requirements, or sponsor decisions, as outlined in the study protocol.
- Monitor study progress and safety data throughout the study
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