SAE reporting SOP Switzerland – Clinical Research Made Simple

SOP for SAE and SUSAR Reporting to Swissmedic

digi — Mon, 01 Sep 2025 14:46:50 +0000

SOP for SAE and SUSAR Reporting to Swissmedic

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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.

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

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

2. SUSAR Reporting Timelines

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

3. Data Entry and Submission

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

4. Follow-Up Reporting

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

5. Documentation and Archiving

Maintain SAE and SUSAR logs in TMF and ISF.
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

Documents

SAE Form (Annexure-1)
SUSAR Log (Annexure-2)
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

For more SOPs visit: Pharma SOP.

SOP for SAE and SUSAR Reporting to Swissmedic

digi — Sun, 31 Aug 2025 01:16:58 +0000

SOP for SAE and SUSAR Reporting to Swissmedic

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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

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

2. SUSAR Reporting Timelines

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

3. Safety Data Submission

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

4. Follow-Up Information

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

5. Documentation and Archiving

Maintain SAE/SUSAR logs, narratives, DSURs, and acknowledgment receipts in TMF.
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

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