Protocol for Participant Monitoring after BA/BE Studies
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for conducting post-study follow-up activities with participants who have completed Bioavailability (BA) and Bioequivalence (BE) studies, ensuring their ongoing well-being, providing necessary support, and facilitating long-term data collection.
Scope
This SOP applies to all study personnel involved in post-study follow-up activities, including Investigators, Study Coordinators, Data Managers, and Clinical Research Associates (CRAs).
Responsibilities
- The Investigator is responsible for overseeing post-study follow-up activities, ensuring participant safety, and providing necessary support and guidance.
- The Study Coordinator is responsible for coordinating post-study follow-up visits or communications with participants, collecting follow-up data, and documenting participant outcomes.
- The Data Manager is responsible for managing post-study follow-up data, ensuring data integrity, and facilitating data analysis and reporting.
- The Clinical Research Associate (CRA) is responsible for monitoring post-study follow-up activities, ensuring compliance with study protocols and regulatory requirements, and providing support to study sites as needed.
Procedure
- Develop a post-study follow-up plan outlining the objectives, timing, and methods for contacting participants after study completion, as specified in the study protocol.
- Contact study participants after study completion to schedule post-study follow-up visits, phone calls, or electronic communications, explaining the purpose of follow-up and obtaining informed consent as necessary.
- Conduct post-study follow-up
visits or communications with participants, collecting relevant data such as medical history, adverse events, concomitant medications, and study outcomes using standardized follow-up forms or questionnaires.
Provide participants with appropriate support and guidance during post-study follow-up, addressing any questions, concerns, or medical issues that may arise, and referring participants to appropriate healthcare providers if needed.
Document all post-study follow-up activities, including participant interactions, data collected, and participant outcomes, in follow-up logs or case report forms (CRFs), ensuring data accuracy, completeness, and confidentiality.
Monitor post-study follow-up activities regularly to ensure adherence to study protocols and regulatory requirements, providing guidance and support to study personnel as needed to address any issues or challenges.
Analyze post-study follow-up data to assess participant outcomes, safety events, and long-term study effects, and prepare summary reports for submission to sponsors, regulatory authorities, and ethics committees as required.
Archive post-study follow-up data and documentation in accordance with regulatory requirements and sponsor guidelines, ensuring data integrity and accessibility for future reference or audit purposes.
Review post-study follow-up procedures periodically to identify areas for improvement and make recommendations for future studies or research projects, incorporating feedback from participants and study personnel.
Abbreviations
- SOP – Standard Operating Procedure
- BA – Bioavailability
- BE – Bioequivalence
- CRF – Case Report Form
- CRA – Clinical Research Associate
Documents
- Post-study Follow-up Plan
- Follow-up Logs or CRFs
- Participant Communication Records
- Post-study Follow-up Reports
Reference
International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for post-study follow-up procedures in clinical research.
SOP Version
Version 1.0