Protocol for Management of Protocol Violations in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the identification, documentation, evaluation, and management of protocol deviations that occur during Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the conduct and oversight of BA/BE studies, including Study Coordinators, Clinical Research Associates (CRAs), Principal Investigators, and Quality Assurance personnel.

Responsibilities

• The Study Coordinator is responsible for identifying and documenting protocol deviations, investigating root causes, and implementing corrective and preventive actions.
• The Clinical Research Associate (CRA) is responsible for monitoring study conduct, identifying protocol violations during site visits, and reporting deviations to the Study Coordinator and Principal Investigator.
• The Principal Investigator is responsible for evaluating the impact of protocol deviations on study integrity, participant safety, and data validity, and making decisions regarding protocol amendments or study continuance.
• The Quality Assurance (QA) personnel are responsible for reviewing protocol deviation reports, assessing compliance with study protocols and regulatory requirements, and providing recommendations for improvement.

Procedure

1. Educate study personnel on protocol requirements, procedures, and expectations to minimize the occurrence of protocol deviations.
2. Implement a system for documenting and reporting protocol deviations, including a standardized deviation form and process for escalation and review.
3. Identify protocol deviations promptly through ongoing monitoring, site visits, participant interviews, and review of study documentation.
4. Document protocol deviations in detail, including the nature of the deviation, date of occurrence, parties involved, and any corrective or preventive actions taken.
5. Evaluate the severity and potential impact of protocol deviations on participant safety, study outcomes, and data integrity.
6. Implement corrective and preventive actions to address protocol deviations, such as re-training study personnel, amending study protocols, or modifying study procedures.
7. Communicate protocol deviations to relevant stakeholders, including study sponsors, regulatory authorities, and institutional review boards (IRBs), as required by regulatory guidelines.
8. Review and assess the effectiveness of corrective actions taken to prevent recurrence of protocol deviations and improve study conduct and compliance.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRA – Clinical Research Associate
• QA – Quality Assurance
• IRB – Institutional Review Board

Documents

• Protocol Deviation Log
• Protocol Deviation Report Form
• Corrective and Preventive Action (CAPA) Plan
• Communication Log

Reference

International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory requirements for handling protocol deviations in clinical research.

SOP Version

Version 1.0