Guidelines for Participant Consent in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for obtaining informed consent from participants in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the recruitment, enrollment, and consent process of study participants, including Principal Investigators, Study Coordinators, and Clinical Research Associates.

Responsibilities

• The Principal Investigator (PI) or Study Coordinator is responsible for ensuring that informed consent is obtained from all study participants.
• The Regulatory Affairs team is responsible for ensuring that the informed consent process complies with regulatory requirements and guidelines.
• Study personnel involved in obtaining informed consent must be adequately trained and competent in explaining study details and answering participant questions.

Procedure

1. Provide participants with comprehensive information about the study purpose, procedures, risks, benefits, and alternatives in a language and format they understand.
2. Ensure that participants have adequate time to review the informed consent document and ask questions before signing.
3. Address any participant concerns or questions in a clear and understandable manner, documenting all discussions and clarifications.
4. Obtain written informed consent from participants or their legally authorized representatives before initiating any study-related procedures.
5. Ensure that participants are informed of their right to withdraw from the study at any time without penalty and how their data will be handled in such cases.
6. Provide participants with a copy of the signed informed consent document for their records.
7. Maintain accurate and up-to-date records of informed consent documentation in the study master file.

Abbreviations

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

Documents

• Informed Consent Form
• Participant Information Sheet
• Record of Informed Consent Discussions
• Consent Documentation Log

Reference

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

SOP Version

Version 1.0