Protocol for Protocol Amendment and Change Control in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for managing changes to study protocols in Bioavailability (BA) and Bioequivalence (BE) studies, ensuring consistency, compliance, and integrity throughout the study conduct.

Scope

This SOP applies to all study personnel involved in the development, review, approval, and implementation of study protocols, including Investigators, Study Coordinators, Regulatory Affairs Officers, and Clinical Research Associates (CRAs).

Responsibilities

• The Investigator is responsible for identifying the need for protocol amendments, assessing their impact on study conduct and participant safety, and obtaining necessary approvals for protocol changes.
• The Study Coordinator is responsible for documenting proposed protocol changes, coordinating protocol amendment submissions, and communicating approved changes to relevant study personnel.
• The Regulatory Affairs Officer is responsible for reviewing protocol amendments for regulatory compliance, preparing regulatory submissions, and obtaining approvals from Institutional Review Boards (IRBs) and regulatory authorities.
• The Clinical Research Associate (CRA) is responsible for ensuring that protocol changes are implemented appropriately at study sites, monitoring compliance with amended protocols, and documenting protocol deviations.

Procedure

1. Educate study personnel about the importance of change management in study protocols, including the need for consistency, clarity, and compliance with regulatory requirements.
2. Establish a Change Control Committee (CCC) or Protocol Review Board (PRB) to review and approve proposed protocol changes, assess their impact on study conduct and participant safety, and ensure regulatory compliance.
3. Document proposed protocol changes using a standardized protocol amendment form, including rationale for the change, proposed revisions, and potential impact on study procedures, endpoints, and participant eligibility criteria.
4. Submit proposed protocol amendments to the Change Control Committee (CCC) or Protocol Review Board (PRB) for review and approval, ensuring that all required documentation and supporting materials are included with the submission.
5. Obtain approvals from Institutional Review Boards (IRBs), regulatory authorities, sponsors, and other relevant stakeholders as required before implementing approved protocol changes.
6. Communicate approved protocol changes to all study personnel, including Investigators, Study Coordinators, and site staff, through training sessions, study meetings, and written communications.
7. Update study documentation, including the study protocol, informed consent documents, case report forms (CRFs), and study manuals, to reflect approved protocol changes accurately and completely.
8. Implement approved protocol changes at study sites promptly, ensuring that all study personnel are aware of and compliant with amended study procedures, endpoints, and participant eligibility criteria.
9. Monitor compliance with amended protocols throughout the study conduct, including regular site visits, monitoring reports, and documentation reviews, to ensure adherence to approved study procedures and regulatory requirements.
10. Document all protocol changes, approvals, communications, and implementation activities in study documentation, protocol amendment records, and communication logs for audit trail purposes.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CCC – Change Control Committee
• PRB – Protocol Review Board
• CRA – Clinical Research Associate
• IRB – Institutional Review Board
• CRF – Case Report Form

Documents

• Protocol Amendment Form
• Communication Log
• Change Control Committee (CCC) Meeting Minutes
• Regulatory Submission Records

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for protocol amendments and change management in clinical research.

SOP Version

Version 1.0