Protocol for Study Personnel Training in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the training of personnel involved in the conduct and oversight of Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all study personnel, including Investigators, Study Coordinators, Clinical Research Associates (CRAs), Data Managers, and Laboratory Technicians.

Responsibilities

• The Study Coordinator is responsible for coordinating and facilitating training sessions, tracking personnel training records, and ensuring that all study personnel receive appropriate training.
• The Investigator is responsible for providing study-specific training to study personnel, ensuring that all personnel understand their roles and responsibilities in the conduct of the study.
• The Clinical Research Associate (CRA) is responsible for providing training on study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements to site staff.
• The Data Manager is responsible for providing training on data collection procedures, data entry, and data management systems to study personnel involved in data collection and management.
• The Laboratory Technician is responsible for providing training on laboratory procedures, equipment operation, and safety protocols to laboratory staff involved in sample processing and analysis.

Procedure

1. Identify the training needs of study personnel based on their roles and responsibilities in the study conduct.
2. Develop a training plan outlining the training objectives, topics, methods, and timelines for each category of study personnel.
3. Provide initial training to study personnel on study protocols, procedures, and regulatory requirements before the start of the study.
4. Conduct ongoing training sessions throughout the study to reinforce key concepts, address any issues or questions that arise, and provide updates on study progress and protocol amendments.
5. Document all training sessions attended by study personnel, including dates, topics covered, and attendees, in individual training records or a centralized training log.
6. Assess the effectiveness of training activities through evaluations, quizzes, or competency assessments to ensure that study personnel have the knowledge and skills required to perform their duties effectively.
7. Provide refresher training as needed to address gaps in knowledge or performance identified during study conduct or quality assurance activities.
8. Review and update training materials, including training manuals, standard operating procedures (SOPs), and instructional videos, to ensure that they reflect current study protocols and best practices.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRA – Clinical Research Associate
• GCP – Good Clinical Practice

Documents

• Training Plan
• Training Records
• Training Materials
• Training Evaluation Forms

Reference

International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for training of study personnel in clinical research.

SOP Version

Version 1.0