and ongoing training, to ensure compliance with Good Clinical Practice (GCP), applicable regulations, and study-specific requirements. Training ensures that staff are competent, compliant, and inspection-ready.

Scope

This SOP applies to all sponsors, investigators, CROs, vendors, and clinical site staff engaged in the conduct of clinical trials. It covers initial GCP training, trial-specific training, SOP training, ongoing competency development, and retraining requirements.

Responsibilities

• Sponsor: Defines minimum training requirements and ensures oversight.
• Investigators: Ensure site staff complete all required training prior to study initiation.
• QA: Verifies compliance through audits of training documentation.
• Site Staff and Vendors: Attend required training sessions and maintain competency.
• Training Coordinator: Schedules, documents, and tracks training activities.

Accountability

The Sponsor and Investigator are accountable for ensuring training compliance before staff perform trial-related tasks. QA is accountable for oversight of training documentation and compliance verification.

Procedure

1. Initial Training
1.1 All staff must complete GCP training before performing study-related tasks.
1.2 Training must include protocol-specific and SOP training.
1.3 Document training completion in Training Log (Annexure-1).

2. Ongoing Training
2.1 Conduct refresher training on GCP every 2 years, or earlier if regulations change.
2.2 Provide ongoing protocol and SOP training when amendments are issued.
2.3 Record all refresher training in Ongoing Training Log (Annexure-2).

3. Role-Specific Training
3.1 Assign role-based training modules for CRAs, investigators, lab staff, data managers, and vendors.
3.2 Ensure staff only perform tasks for which they are trained.

4. CAPA-Driven Retraining
4.1 Initiate retraining if deviations or inspection findings identify training gaps.
4.2 Document retraining sessions in CAPA Training Log (Annexure-3).

5. Training Records
5.1 Maintain training certificates, attendance sheets, and electronic logs in the Trial Master File (TMF).
5.2 Training records must be available for audit and inspection.

6. Evaluation
6.1 Conduct knowledge assessments after training.
6.2 Track results in Training Assessment Log (Annexure-4).

Abbreviations

• SOP: Standard Operating Procedure
• GCP: Good Clinical Practice
• CRA: Clinical Research Associate
• QA: Quality Assurance
• CRO: Contract Research Organization
• CAPA: Corrective and Preventive Action
• TMF: Trial Master File

Documents

1. Training Log (Annexure-1)
2. Ongoing Training Log (Annexure-2)
3. CAPA Training Log (Annexure-3)
4. Training Assessment Log (Annexure-4)

References

• ICH E6(R2/R3) – GCP Training Requirements
• FDA – Clinical Investigator Training Requirements
• EMA – GCP Training Guidance
• CDSCO – Training in Clinical Research
• WHO – Clinical Trial Training Guidelines

Version: 1.0

Approval Section

Prepared By	Ravi Kumar, Training Coordinator
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Head Clinical Quality

Annexures

Annexure-1: Training Log

Date	Name	Role	Training Type	Trainer
01/09/2025	Meena Sharma	CRA	GCP Initial Training	QA Officer

Annexure-2: Ongoing Training Log

Date	Name	Role	Training Topic	Trainer
05/09/2025	Ravi Kumar	Data Manager	Protocol Amendment Training	Study Lead

Annexure-3: CAPA Training Log

Date	Name	CAPA ID	Training Topic	Trainer
12/09/2025	Sunita Reddy	CAPA-2025-02	SOP Compliance	QA Manager

Annexure-4: Training Assessment Log

Date	Name	Assessment Type	Score	Evaluator
15/09/2025	Meena Sharma	GCP Knowledge Test	90%	QA Officer

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head Clinical Quality

For more SOPs visit: Pharma SOP