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

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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