equipment failures during the clinical phase.

3. Responsibilities

• Clinical Investigator: Responsible for assessing, documenting, and reporting the incident and its impact on subject safety or data integrity.
• Study Coordinator: Maintains the incident reporting log and ensures documentation of all reports and follow-ups.
• QA Officer: Reviews all incident reports for CAPA requirements and ensures compliance audits.
• Clinical Operations Manager: Ensures that systemic issues are identified and escalated for resolution.

4. Accountability

The Principal Investigator is accountable for ensuring that all trial-related incidents are reported, assessed, documented, and resolved in a timely and compliant manner.

5. Procedure

5.1 Identification of Incidents

1. Incidents may include but are not limited to:
   • Subject safety concerns
   • Non-compliance to protocol procedures
   • Improper handling of IMP or samples
   • Failure of monitoring devices
   • Breaches in confidentiality
2. Any staff member who identifies an incident must immediately inform the Study Coordinator and PI.

5.2 Preliminary Documentation

1. Complete the Incident Reporting Form (Annexure-1) including:
   • Date and time
   • Location
   • Description
   • Persons involved
   • Immediate actions taken
2. Assign a unique Incident ID following format: INC/YY/XXX (e.g., INC/25/001).
3. Log the incident in Annexure-2: Clinical Incident Log.

5.3 Incident Evaluation and Impact Assessment

1. PI shall evaluate whether the incident:
   • Affects subject safety
   • Impacts study integrity
   • Requires deviation reporting to sponsor/IEC
2. Medical Officer shall assess need for medical intervention or AE/SAE reporting.
3. QA to verify whether it is a repeat incident or systemic issue.

5.4 Corrective and Preventive Actions (CAPA)

1. PI and QA team jointly define:
   • Corrective Action: Steps taken to immediately address the issue
   • Preventive Action: Steps to prevent recurrence
2. Document CAPA in Annexure-3: CAPA Implementation Log.
3. Assign follow-up timelines and responsible persons.

5.5 Communication and Reporting

1. Report the incident to the sponsor within 24–48 hours if:
   • Subject is withdrawn
   • Major protocol deviation occurred
   • Data integrity is impacted
2. Notify IEC/IRB per their SOPs if incident is classified as reportable.
3. File copies of all communications in TMF and subject file if relevant.

5.6 Closure and Archival

1. Upon implementation of CAPA, update incident status as “Closed” in the log.
2. All supporting documents, logs, and communications must be archived in the QA section of the TMF.

6. Abbreviations

• BA/BE: Bioavailability / Bioequivalence
• PI: Principal Investigator
• AE: Adverse Event
• SAE: Serious Adverse Event
• CAPA: Corrective and Preventive Action
• IEC: Institutional Ethics Committee
• TMF: Trial Master File

7. Documents

1. Incident Reporting Form – Annexure-1
2. Clinical Incident Log – Annexure-2
3. CAPA Implementation Log – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• CDSCO BA/BE Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Incident Reporting Form

Incident ID	Date	Description	Persons Involved	Immediate Action
INC/25/003	17/04/2025	Blood sample mislabeled	Ravi Sharma	Sample discarded

Annexure-2: Clinical Incident Log

Incident ID	Status	Date	Reported By	Closed On
INC/25/003	Closed	17/04/2025	Ravi Sharma	19/04/2025

Annexure-3: CAPA Implementation Log

Incident ID	Corrective Action	Preventive Action	Responsible	Due Date
INC/25/003	Sample discarded, volunteer re-sampled	Barcode scanning training	QA Officer	22/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
17/04/2025	2.0	Expanded CAPA and classification of incidents	Audit compliance	QA Head