Protocol for Oversight of BA/BE Study Sites and Monitoring Activities

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for clinical monitoring and site management activities in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the oversight and monitoring of BA and BE study sites, including Clinical Research Associates (CRAs), Clinical Monitors, and Study Managers.

Responsibilities

• The Study Manager or Clinical Trial Manager is responsible for overall oversight of clinical monitoring and site management activities, including the development and implementation of monitoring plans.
• The Clinical Research Associate (CRA) is responsible for conducting site visits, monitoring study conduct and data integrity, and ensuring compliance with the study protocol and regulatory requirements.
• The Principal Investigator (PI) or Site Coordinator is responsible for providing access to study documents, facilities, and personnel during site visits and addressing any findings or recommendations from the monitoring visits.

Procedure

1. Develop a monitoring plan outlining the frequency and scope of site visits, monitoring activities, and responsibilities of the monitoring team.
2. Conduct pre-study site visits to assess site capabilities, infrastructure, and personnel qualifications before study initiation.
3. Perform routine site visits during the course of the study to verify protocol compliance, data accuracy, and participant safety.
4. Review study documents, source documents, and electronic records to ensure completeness, accuracy, and compliance with regulatory requirements.
5. Communicate findings and recommendations to the site staff and study team during site visits, documenting all observations and actions taken.
6. Follow up on corrective and preventive actions (CAPAs) identified during site visits to ensure timely resolution and continued compliance.
7. Prepare monitoring reports summarizing findings, observations, and actions taken during site visits for inclusion in the study file and sponsor reporting.
8. Participate in sponsor audits, regulatory inspections, and internal quality assurance activities as needed.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRA – Clinical Research Associate
• PI – Principal Investigator

Documents

• Monitoring Plan
• Site Visit Reports
• Corrective and Preventive Action (CAPA) Plans
• Monitoring Visit Checklist

Reference

International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory requirements for clinical trial monitoring.

SOP Version

Version 1.0