Protocol for Ethical Review in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for obtaining ethical approval for Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the planning, conduct, and oversight of BA and BE studies, including Principal Investigators, Study Directors, and Regulatory Affairs personnel.

Responsibilities

• The Principal Investigator (PI) or Study Director is responsible for preparing and submitting the study protocol and other relevant documents for ethical review.
• The Regulatory Affairs team is responsible for facilitating communication with the ethics committee and ensuring that all required documents are submitted in a timely manner.
• The Ethics Committee members are responsible for reviewing study protocols and associated documents to ensure that the rights, safety, and well-being of study participants are protected.

Procedure

1. Prepare the study protocol, informed consent forms, and any other relevant documents required for ethical review.
2. Submit the documents to the appropriate ethics committee for review and approval.
3. Address any feedback or concerns raised by the ethics committee in a timely manner.
4. Revise the study protocol and documents as necessary based on the feedback received.
5. Obtain written approval from the ethics committee before initiating any study-related activities involving human participants.
6. Maintain ongoing communication with the ethics committee throughout the duration of the study, providing updates and addressing any protocol deviations or adverse events.
7. Ensure that all study personnel are aware of and adhere to the approved study protocol and ethical guidelines throughout the conduct of the study.
8. Document all interactions with the ethics committee, including meeting minutes, correspondence, and approval documents, in the study master file.

Abbreviations

• BA – Bioavailability
• BE – Bioequivalence
• PI – Principal Investigator
• SOP – Standard Operating Procedure

Documents

• Study Protocol
• Informed Consent Forms
• Correspondence with Ethics Committee
• Approval Documents

Reference

International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines.

SOP Version

Version 1.0