Protocol for Managing Participant Withdrawals in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for handling participant dropouts and withdrawals from Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all study personnel involved in participant recruitment, enrollment, and study conduct, including Investigators, Study Coordinators, and Clinical Research Associates (CRAs).

Responsibilities

• The Investigator is responsible for documenting participant withdrawals, assessing the reasons for withdrawal, and determining the impact of withdrawals on study integrity and data analysis.
• The Study Coordinator is responsible for notifying the sponsor and regulatory authorities of participant withdrawals, updating study records, and implementing strategies to mitigate the impact of withdrawals on study timelines and objectives.
• The Clinical Research Associate (CRA) is responsible for monitoring participant enrollment and withdrawals, identifying trends or patterns in participant withdrawals, and reporting withdrawal-related issues to the sponsor.

Procedure

1. Document participant withdrawals promptly upon notification of withdrawal by the participant, study site personnel, or sponsor.
2. Assess the reasons for participant withdrawals, including voluntary withdrawals, withdrawals due to adverse events, loss to follow-up, or protocol deviations.
3. Determine the impact of participant withdrawals on study objectives, statistical analysis, and sample size calculations.
4. Notify the sponsor and regulatory authorities of participant withdrawals as required by study protocols, regulatory guidelines, and contractual agreements.
5. Update study records, including case report forms (CRFs), study databases, and regulatory submissions, to reflect participant withdrawals and the disposition of study data.
6. Implement strategies to mitigate the impact of participant withdrawals on study timelines and objectives, such as additional recruitment efforts, protocol amendments, or statistical adjustments.
7. Monitor participant withdrawals throughout the study conduct and identify any trends or patterns in participant withdrawals that may require further investigation or action.
8. Document all actions taken in response to participant withdrawals, including communication with participants, sponsors, and regulatory authorities, in study documentation and correspondence logs.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRA – Clinical Research Associate
• CRF – Case Report Form

Documents

• Withdrawal Log
• Communication Log
• Protocol Deviation Report
• Study Database

Reference

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

SOP Version

Version 1.0