Standard Operating Procedure for Training of Study Staff on Protocol and GCP in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/036/2025
Supersedes	SOP/BA-BE/036/2022
Page No.	Page 1 of 13
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define the process for training study personnel on the study protocol and applicable Good Clinical Practice (GCP) guidelines prior to initiation of Bioavailability/Bioequivalence (BA/BE) studies, ensuring subject protection, data integrity, and regulatory compliance.

2. Scope

This SOP applies to all clinical staff, investigators, coordinators, pharmacists, nurses, data managers, and any other personnel directly or indirectly involved in the conduct of BA/BE studies sponsored or managed by the organization.

3. Responsibilities

• Clinical Project Manager: Coordinates and schedules training sessions.
• Principal Investigator: Ensures site staff complete training before involvement in any study-related activity.
• Quality Assurance: Reviews training documentation during audits.
• Trainer (e.g., Medical Monitor or Study Manager): Conducts the protocol and GCP training.

4. Accountability

The Head of Clinical Research is accountable for ensuring that all study staff are adequately trained and that training records are complete and available for inspection.

5. Procedure

5.1 Training Preparation

1. Develop a training plan using Annexure-1: Study Staff Training Schedule.
2. Gather training materials:
   • Final approved protocol
   • Investigator’s Brochure (if applicable)
   • ICH E6(R2) GCP guideline
   • Sponsor-specific SOPs relevant to site activities

5.2 Conducting the Training

1. Deliver training through an in-person meeting or virtual conference.
2. Include the following in the training content:
   • Study rationale, objectives, and design
   • Eligibility criteria and visit schedule
   • Dosing, sampling, and AE reporting procedures
   • Informed consent process
   • Source documentation and CRF completion
   • GCP roles and responsibilities
3. Allow time for questions and clarify site-specific responsibilities.

5.3 Documentation

1. Record attendance using Annexure-2: Training Attendance Log.
2. Each attendee must complete and sign Annexure-3: Training Acknowledgement Form.
3. Trainer signs Annexure-4: Training Delivery Certification.

5.4 Filing and Archival

1. Place completed training documents in the Investigator Site File (ISF) and Trial Master File (TMF).
2. Maintain electronic backup in secure clinical trial documentation system.

5.5 Retraining Requirements

1. Conduct retraining in the following scenarios:
   • Amendment to protocol
   • Staff turnover at site
   • Deviations indicating process misunderstanding
2. Document retraining in the same manner as initial training.

6. Abbreviations

• GCP: Good Clinical Practice
• CRF: Case Report Form
• ISF: Investigator Site File
• TMF: Trial Master File
• AE: Adverse Event

7. Documents

1. Study Staff Training Schedule – Annexure-1
2. Training Attendance Log – Annexure-2
3. Training Acknowledgement Form – Annexure-3
4. Training Delivery Certification – Annexure-4

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules
• Organization Clinical Trial Training Policy

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Study Staff Training Schedule

Session Date	Trainer	Topics Covered	Mode	Duration
12/04/2025	Dr. Arvind Shah	Protocol BE-041, GCP Basics	Online	2 hrs

Annexure-2: Training Attendance Log

Name	Designation	Department	Email	Signature
Sunita Reddy	Study Coordinator	Clinical	sunita.r@domain.com

Annexure-3: Training Acknowledgement Form

I acknowledge that I have received, understood, and will comply with the training provided on the above-mentioned protocol and GCP requirements.

Name: _____________________ Signature: _____________________ Date: ___________

Annexure-4: Training Delivery Certification

Trainer Name	Designation	Date of Training	Mode	Signature
Dr. Arvind Shah	Medical Monitor	12/04/2025	Online

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
14/01/2022	1.0	Initial version	New SOP implementation	QA Head
17/04/2025	2.0	Expanded retraining criteria, added new annexures	Audit readiness	QA Head