and includes all study team members involved in safety monitoring, documentation, and regulatory communication.

3. Responsibilities

• Principal Investigator (PI): Reviews all safety data, assesses causality and severity, and signs off SAE reports.
• Clinical Safety Officer: Coordinates safety documentation, prepares reports, and ensures timelines are met.
• Clinical Research Coordinator (CRC): Assists in identifying and documenting AEs and SAEs in source documents and CRFs.
• QA Department: Audits safety reporting logs and ensures compliance with reporting SOPs and timelines.

4. Accountability

The Medical Director is accountable for ensuring timely and accurate safety reporting to the Sponsor and EC as per protocol and regulatory requirements.

5. Procedure

5.1 Adverse Event Identification and Initial Reporting

1. All medical issues experienced by subjects, whether related or unrelated to the study drug, must be recorded as AEs.
2. The CRC must notify the Clinical Safety Officer and PI within 2 hours of identifying any SAE.
3. Document details in source notes, AE Log, and Annexure-1: Adverse Event Reporting Form.

5.2 SAE Assessment and Classification

1. The PI shall evaluate and classify the event based on:
   • Seriousness (e.g., hospitalization, life-threatening, disability)
   • Expectedness (based on Investigator’s Brochure or Product Insert)
   • Causality (related/unrelated/probable/possible)
2. Severity grading (mild, moderate, severe) must be documented.

5.3 SAE Reporting to Sponsor

1. Initial SAE report must be sent to the Sponsor within 24 hours of awareness using Annexure-2: SAE Notification Form.
2. Include:
   • Subject details (coded ID)
   • Event description and timelines
   • Concomitant medications
   • Outcome (if available)
   • Medical assessment
3. Follow-up reports must be submitted within 7 calendar days or earlier upon request.

5.4 Reporting to Ethics Committee (IEC/IRB)

1. Submit a copy of the SAE report to the IEC within 7 working days of occurrence.
2. Include covering letter, SAE form, PI assessment, and any hospital documents in a compiled dossier (Annexure-3).
3. Ensure acknowledgment receipt is recorded in Annexure-4: EC Submission Log.

5.5 Safety Follow-Up and Monitoring

1. Ensure regular follow-up with the subject until the resolution or stabilization of the SAE.
2. Update sponsor and EC with outcome status using Annexure-5: SAE Follow-Up Form.

5.6 Regulatory Compliance and Timelines

1. All reports must comply with Schedule Y timelines and applicable ICH guidelines.
2. Maintain SAE communication records for a minimum of 5 years post-study completion.

5.7 Serious Breaches

1. If the SAE indicates a serious breach of GCP or protocol:
   • Notify the Sponsor and EC immediately
   • Initiate internal CAPA (Corrective and Preventive Action)
   • Document in Annexure-6: Serious Breach Report

6. Abbreviations

• AE: Adverse Event
• SAE: Serious Adverse Event
• EC: Ethics Committee
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• CAPA: Corrective and Preventive Action

7. Documents

1. Adverse Event Reporting Form – Annexure-1
2. SAE Notification Form – Annexure-2
3. SAE Submission Dossier to EC – Annexure-3
4. EC Submission Log – Annexure-4
5. SAE Follow-Up Form – Annexure-5
6. Serious Breach Report – Annexure-6

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• WHO Guidelines for Clinical Safety Reporting

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Adverse Event Reporting Form

Subject ID	VOL1071
Date of AE	15/04/2025
Description	Mild dizziness post-dose
Severity	Mild
Outcome	Resolved

Annexure-2: SAE Notification Form

Subject ID	VOL1085
SAE Type	Hospitalization due to syncope
Onset Date	16/04/2025
PI Assessment	Possibly related

Annexure-3: SAE Submission Dossier to EC

Document	Included
Cover Letter	Yes
SAE Form	Yes
Hospital Records	Yes
PI Assessment	Yes

Annexure-4: EC Submission Log

Date	Subject ID	Submitted To	Mode	Received By
17/04/2025	VOL1085	IEC-A	Email	Dr. Sangeeta Iyer

Annexure-5: SAE Follow-Up Form

Subject ID	VOL1085
Event Outcome	Recovered on 18/04/2025
Final Assessment	Event resolved without sequelae

Annexure-6: Serious Breach Report

Issue	Failure to notify SAE within 24 hours
Impact	Regulatory non-compliance
CAPA	Re-training of CRC, escalation SOP amended

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 to include new annexures and follow-up formats	Inspection Readiness	QA Head