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Published on 22/12/2025

SAE and SUSAR Reporting to Swissmedic SOP

Department	Clinical Research
SOP No.	CS/SWISS-SAF/192/2025
Supersedes	N.A.
Page No.	1 of 24
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

This SOP establishes procedures for reporting Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) to Swissmedic and Ethics Committees (via BASEC). It ensures compliance with ClinO, ICH GCP, and subject safety protection requirements.

Scope

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

Responsibilities

• Principal Investigator (PI): Detects and reports SAEs to the sponsor within 24 hours, ensures SAE forms are completed, and files in ISF.
• Clinical Research Coordinator (CRC): Assists in documenting and reporting SAEs.
• Sponsor PV Team: Assesses seriousness, expectedness, and causality; prepares SUSARs; and ensures submissions to Swissmedic.
• Regulatory Affairs (RA): Confirms Swissmedic and BASEC acknowledgments are received and logged.
• Quality Assurance (QA): Monitors PV systems and ensures inspection readiness.
• CRO: Supports sponsor in safety reporting activities if delegated.

Accountability

The Qualified Person for Pharmacovigilance (QPPV) or equivalent in Switzerland is accountable for compliance with SAE and SUSAR reporting obligations. The PI is accountable for timely and accurate SAE reporting at the site.

Procedure

1. SAE Identification and Initial Documentation

1. All SAEs must be recorded within 24 hours of investigator awareness using SAE forms.
2. Initial SAE reports must include subject ID, event description, onset date, severity, causality, and outcome.
3. Copies of completed SAE reports must be filed in ISF and sent to sponsor.

2. SUSAR Reporting Timelines

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

3. Safety Data Submission

1. Submit expedited reports electronically via Swissmedic’s pharmacovigilance portal.
2. Ensure DSURs are submitted annually with cumulative safety data.

4. Follow-Up Information

1. Collect and document follow-up details for all SUSARs.
2. Submit updates to Swissmedic and BASEC promptly.

5. Documentation and Archiving

1. Maintain SAE/SUSAR logs, narratives, DSURs, and acknowledgment receipts in TMF.
2. Archive safety records for at least 10 years in accordance with ClinO requirements.

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

Documents

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

References

• Swissmedic — Safety Reporting
• BASEC — Ethics Committees Switzerland
• ICH E2A: Clinical Safety Data Management
• ICH E2F: Development Safety Update Report

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-201	Severe Neutropenia	10/08/2025	Recovered	Related	11/08/2025

Annexure-2: SUSAR Log

Date	Case ID	Event	Submitted To	Status
15/08/2025	SUSAR-001	Seizure	Swissmedic & BASEC	Submitted

Annexure-3: DSUR Submission Log

Protocol No.	Period	Submission Date	Status	Owner
CH-2025-01	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 compliance with ClinO and ICH GCP requirements.	Head of Clinical Research

For more SOPs visit: Pharma SOP.