Protocol for Participant Recruitment in BA/BE Studies
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the recruitment and selection of participants in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.
Scope
This SOP applies to all personnel involved in the recruitment and selection process, including Principal Investigators, Study Coordinators, and Clinical Research Associates.
Responsibilities
- The Principal Investigator (PI) or Study Coordinator is responsible for overseeing the recruitment and selection process and ensuring that it complies with the study protocol and regulatory requirements.
- The Recruitment Team is responsible for identifying potential participants and informing them about the study.
- The Screening Team is responsible for assessing participant eligibility based on study criteria.
Procedure
- Develop recruitment strategies tailored to the target population and study requirements.
- Identify potential participants through various channels such as advertisements, referrals, and databases.
- Screen potential participants for eligibility based on predefined criteria outlined in the study protocol.
- Provide eligible participants with detailed information about the study purpose, procedures, risks, and benefits.
- Obtain informed consent from eligible participants before enrollment into the study.
- Randomize participants if applicable, ensuring blinding procedures are followed.
- Monitor recruitment progress and adjust strategies as needed to meet enrollment targets.
- Maintain accurate and up-to-date records of participant recruitment and selection activities.
Abbreviations
- SOP – Standard Operating Procedure
- BA – Bioavailability
- BE – Bioequivalence
- PI – Principal Investigator
Documents
- Recruitment Plan
- Informed Consent Form
- Participant Screening Log
- Enrollment Tracker
Reference
International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines.
SOP Version
Version 1.0