spillage or incidents involving investigational products (IP) and biological materials in clinical trials. It ensures protection of staff, subjects, and the environment while maintaining proper documentation and regulatory compliance.

Scope

This SOP applies to all staff at clinical trial sites handling IP and biological materials, including investigators, pharmacists, nurses, coordinators, and laboratory personnel. It covers spillage during receipt, storage, preparation, dispensing, administration, or transportation of IPs and biologicals.

Responsibilities

• Principal Investigator (PI): Responsible for oversight of incident management and reporting to sponsor and regulatory authorities.
• Pharmacist/Study Nurse: Executes spill management procedures, ensures staff safety, and documents the incident.
• Study Coordinator: Maintains incident reports and files records in ISF and TMF.
• Sponsor/CRO: Reviews incident reports, assesses impact, and ensures regulatory reporting is completed.
• Quality Assurance Officer: Audits incident handling and verifies corrective actions.

Accountability

The PI is accountable for ensuring immediate and effective management of IP/biological spillage incidents. Sponsors are accountable for oversight and verification of compliance with reporting and corrective action requirements.

Procedure

1. Immediate Response
Alert all personnel and restrict access to the area.
Wear appropriate personal protective equipment (PPE).
Contain the spill using absorbent pads or spill kits.

2. Spill Cleanup
Collect spilled material safely using designated spill kits.
Dispose of contaminated materials as per hazardous waste regulations.
Decontaminate surfaces with appropriate disinfectant.

3. Medical Emergencies
If exposure occurs, provide first aid and medical treatment immediately.
Record incident in Exposure/Incident Report (Annexure-1).

4. Documentation
Complete Spillage Incident Report Form (Annexure-2).
Record batch number, subject ID (if applicable), and amount lost.
File records in ISF and TMF.

5. Reporting
Notify PI, sponsor, and QA immediately.
Report serious incidents to EC/IRB and regulatory authority if required.

6. Corrective and Preventive Actions (CAPA)
Conduct root cause analysis of incident.
Implement CAPA and document actions in CAPA Log (Annexure-3).

7. Archiving
Archive incident records and CAPA documentation for minimum 5 years post-trial or as per national regulations.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• IP: Investigational Product
• CRO: Clinical Research Organization
• ISF: Investigator Site File
• TMF: Trial Master File
• PPE: Personal Protective Equipment
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

Documents

1. Exposure/Incident Report (Annexure-1)
2. Spillage Incident Report Form (Annexure-2)
3. CAPA Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Guidance on Handling of Investigational Products
• EMA Clinical Trial Regulation
• CDSCO Clinical Trial Rules, 2019
• WHO – Laboratory Biosafety and Biological Spill Response Guidelines

Version: 1.0

Approval Section

Prepared By	Rajesh Kumar, Clinical Research Pharmacist
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Principal Investigator

Annexures

Annexure-1: Exposure/Incident Report

Date	Name	Incident	Exposure Type	Action Taken
12/09/2025	Ravi Kumar	Spill during transfer	Skin contact	Washed, medical check-up

Annexure-2: Spillage Incident Report Form

Date	IP Name	Batch No.	Quantity Spilled	Location	Recorded By
13/09/2025	Biological Sample A	LOT-2025X	20 ml	Pharmacy	Sunita Sharma

Annexure-3: CAPA Log

Date	Incident	Corrective Action	Preventive Action	Reviewed By
15/09/2025	IP Spillage	Immediate cleanup & retraining	Spill drill conducted	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 Research

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