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“headline”: “SOP for SAE and SUSAR Reporting to Swissmedic”,
“name”: “SOP for SAE and SUSAR Reporting to Swissmedic”,
“description”: “Detailed SOP describing investigator, sponsor, and CRO responsibilities for SAE and SUSAR reporting to Swissmedic and BASEC in compliance with Swiss GCP and ClinO requirements.”,
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“datePublished”: “2025-08-28”,
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SAE and SUSAR Reporting to Swissmedic SOP

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

Annexures

Annexure-1: SAE Form

Annexure-2: SUSAR Log

Annexure-3: DSUR Submission Log

Revision History

For more SOPs visit: Pharma SOP.