SOP for SAE and SUSAR Reporting to Swissmedic

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SOP for SAE and SUSAR Reporting to Swissmedic

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Published on 22/12/2025

SAE and SUSAR Reporting to Swissmedic SOP

Department Clinical Research
SOP No. CS/SWISS-SAF/194/2025
Supersedes N.A.
Page No. 1 of 24
Issue Date 28/08/2025
Effective Date 05/09/2025
Review Date 05/09/2027

Purpose

The purpose of this SOP is to define a clear, regulatory-compliant process for reporting Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) in Switzerland. It ensures compliance with the Ordinance on Clinical Trials (ClinO), ICH GCP, Swissmedic requirements, and ethics committee oversight, thereby safeguarding trial subjects and maintaining trial credibility.

Scope

This SOP applies to all sponsor-led and investigator-initiated clinical trials in Switzerland. It covers SAE detection, documentation, causality assessment, SUSAR expedited reporting, Development Safety Update Report (DSUR) submissions, and archiving. It applies to sponsors, investigators, CROs, pharmacovigilance teams, and regulatory affairs staff.

Responsibilities

  • Principal Investigator (PI): Identifies and documents SAEs, ensures initial notification to the sponsor within 24 hours, and files SAE forms in ISF.
  • Clinical Research Coordinator (CRC): Supports the PI in SAE reporting and maintains site safety documentation.
  • Sponsor Pharmacovigilance (PV) Team: Assesses causality, expectedness, and seriousness, prepares SUSAR submissions, and ensures compliance with timelines.
  • Regulatory Affairs (RA): Submits SUSARs and DSURs to Swissmedic and BASEC, ensuring acknowledgment receipts are filed.
  • Quality Assurance (QA): Conducts audits of safety documentation and ensures inspection readiness.
  • CRO (if applicable): Provides PV support and manages delegated reporting activities.
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Accountability

The Qualified Person for Pharmacovigilance (QPPV) or designated Swiss safety officer is accountable for ensuring all SAE and SUSAR reporting obligations are met. The PI is accountable for timely identification and reporting of safety events at site level.

Procedure

1. SAE Identification and Reporting

  1. Record all SAEs in SAE forms within 24 hours of awareness.
  2. Send SAE reports to sponsor PV team for assessment.
  3. File all SAE documentation in ISF.

2. SUSAR Reporting Timelines

  1. Fatal or life-threatening SUSARs: submit within 7 calendar days to Swissmedic and BASEC, with follow-up within 8 days.
  2. Other SUSARs: submit within 15 calendar days.

3. Data Entry and Submission

  1. Submit SUSARs electronically via Swissmedic’s reporting system.
  2. Ensure DSURs are prepared annually and submitted within 60 days of data lock point.

4. Follow-Up Reporting

  1. Collect additional information for all SUSARs and submit updated reports.
  2. Ensure BASEC is informed of safety updates.

5. Documentation and Archiving

  1. Maintain SAE and SUSAR logs in TMF and ISF.
  2. Archive all safety documentation for at least 10 years in compliance with ClinO.

Abbreviations

  • SAE: Serious Adverse Event
  • SUSAR: Suspected Unexpected Serious Adverse Reaction
  • DSUR: Development Safety Update Report
  • PI: Principal Investigator
  • CRC: Clinical Research Coordinator
  • PV: Pharmacovigilance
  • RA: Regulatory Affairs
  • QA: Quality Assurance
  • QPPV: Qualified Person for Pharmacovigilance
  • TMF: Trial Master File
  • ISF: Investigator Site File
  • BASEC: Business Administration System for Ethics Committees
  • ClinO: Ordinance on Clinical Trials in Human Research
See also  SOP for Data Coding, Cleaning, and Quality Checks

Documents

  1. SAE Form (Annexure-1)
  2. SUSAR Log (Annexure-2)
  3. DSUR Submission Tracker (Annexure-3)

References

Version: 1.0

Approval

Prepared By Checked By Approved By
Name: Rajesh Kumar
Date: 20/08/2025
Signature: __________		 Name: Sunita Reddy
Date: 22/08/2025
Signature: __________		 Name: Dr. Meera Iyer
Date: 28/08/2025
Signature: __________

Annexures

Annexure-1: SAE Form

Subject ID Event Onset Date Outcome Investigator Assessment Date Reported
CH-301 Anaphylaxis 10/08/2025 Recovered Related 11/08/2025

Annexure-2: SUSAR Log

Date Case ID Event Submitted To Status
15/08/2025 SUSAR-101 Seizure Swissmedic & BASEC Submitted

Annexure-3: DSUR Submission Tracker

Protocol No. Period Submission Date Status Owner
CH-2025-02 01/08/2024 – 31/07/2025 20/09/2025 Submitted Neha Sharma

Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
28/08/2025 1.0 Initial SOP for SAE and SUSAR reporting to Swissmedic. New SOP created for Swissmedic compliance. Head of Clinical Research

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