Procedure for Defining Study Participant Criteria

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for defining and implementing exclusion and inclusion criteria for selecting participants in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the development, review, and implementation of exclusion and inclusion criteria, including Principal Investigators, Study Coordinators, and Clinical Research Associates.

Responsibilities

• The Principal Investigator (PI) or Study Coordinator is responsible for defining the exclusion and inclusion criteria based on study objectives, protocol requirements, and regulatory guidelines.
• The Study Team is responsible for reviewing and providing input on proposed criteria to ensure they are clear, feasible, and appropriate for the study population.
• The Regulatory Affairs team is responsible for ensuring that the criteria comply with regulatory requirements and are properly documented in the study protocol.

Procedure

1. Review relevant literature, regulatory guidelines, and previous studies to identify factors that may influence participant eligibility and study outcomes.
2. Consult with clinical experts, statisticians, and other relevant stakeholders to define clear and objective exclusion and inclusion criteria.
3. Document the criteria in the study protocol, including specific parameters, thresholds, and any exceptions or special considerations.
4. Ensure that the criteria are applied consistently and uniformly during participant screening and enrollment.
5. Regularly review and update the criteria as needed based on emerging data, study progress, and feedback from study personnel.
6. Document any deviations from the predefined criteria and the rationale for these deviations in the study records.

Abbreviations

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

Documents

• Study Protocol
• Participant Screening Log
• Meeting Minutes (for criteria review meetings)
• Protocol Amendments (if criteria are revised)

Reference

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

SOP Version

Version 1.0