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Published on 24/12/2025

ClinO and ClinO-MD Compliance in Submissions and Conduct SOP

Department	Clinical Research
SOP No.	CS/SWISS-CLINO/189/2025
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 processes for ensuring compliance with the Swiss Ordinance on Clinical Trials in Human Research (ClinO) and the Ordinance on Clinical Trials with Medical Devices (ClinO-MD). It outlines the submission, approval, conduct, monitoring, and reporting requirements under Swissmedic, ensuring ethical and regulatory adherence.

Scope

This SOP applies to all clinical trials involving medicinal products and medical devices conducted in Switzerland under ClinO and ClinO-MD regulations. It covers sponsor obligations, investigator responsibilities, ethics committee submissions, safety reporting, amendments, and archiving of trial documents.

Responsibilities

• Sponsor: Ensures compliance with ClinO and ClinO-MD requirements, prepares submission dossiers, and maintains oversight.
• Regulatory Affairs (RA): Submits dossiers to Swissmedic and BASEC (ethics committee) and tracks approvals.
• Principal Investigator (PI): Conducts trials per ClinO/ClinO-MD, maintains documentation, and ensures subject safety.
• Clinical Project Manager (CPM): Coordinates timelines and ensures trial conduct is aligned with approvals.
• Quality Assurance (QA): Audits trial documents and processes to ensure readiness for inspections.

Accountability

The Sponsor’s Head of Regulatory Affairs is accountable for compliance with ClinO/ClinO-MD obligations. The PI is accountable for site-level adherence and subject protection.

Procedure

1. Preparation of Submission Dossier

1. Compile CTA dossier including protocol, Investigator’s Brochure, ICF, IMPD (for drugs), or device dossier (for medical devices).
2. Ensure translations into German, French, or Italian as required.
3. Maintain Submission Checklist (Annexure-1).

2. Submissions to Swissmedic and BASEC

1. Submit dossiers electronically through Swissmedic and BASEC portals.
2. Record submission acknowledgments in Submission Log.

3. Trial Conduct and Monitoring

1. Conduct trial in compliance with ClinO/ClinO-MD, GCP, and local ethics requirements.
2. Maintain Trial Master File (TMF) with all essential documents.

4. Safety Reporting

1. Submit SUSARs to Swissmedic and BASEC within required timelines.
2. Report annual safety updates (DSURs) to authorities.

5. Protocol Amendments

1. Submit substantial amendments to Swissmedic and BASEC prior to implementation.
2. Record approvals in Amendment Log (Annexure-2).

6. Archiving

1. Archive TMF and ISF records for at least 10 years or as per ClinO retention requirements.

Abbreviations

• ClinO: Ordinance on Clinical Trials in Human Research
• ClinO-MD: Ordinance on Clinical Trials with Medical Devices
• Swissmedic: Swiss Agency for Therapeutic Products
• BASEC: Business Administration System for Ethics Committees
• CTA: Clinical Trial Application
• ICF: Informed Consent Form
• IMPD: Investigational Medicinal Product Dossier
• PI: Principal Investigator
• RA: Regulatory Affairs
• QA: Quality Assurance
• CPM: Clinical Project Manager
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. Submission Checklist (Annexure-1)
2. Amendment Log (Annexure-2)
3. Safety Reporting Log (Annexure-3)

References

• Swissmedic — Clinical Trials
• BASEC — Ethics Committees Switzerland
• ICH E6(R2) Good Clinical Practice

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: Submission Checklist

Document	Included (Y/N)	Reviewer	Date
Protocol	Y	Rajesh Kumar	05/08/2025
Investigator’s Brochure	Y	Sunita Reddy	06/08/2025

Annexure-2: Amendment Log

Date	Amendment	Submitted To	Status	Owner
15/09/2025	Amendment 1 — Updated risk management plan	Swissmedic & BASEC	Under Review	Neha Sharma

Annexure-3: Safety Reporting Log

Date	Case ID	Event	Submitted To	Status
12/08/2025	CH-001	Severe Anaphylaxis	Swissmedic	Submitted

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for ClinO and ClinO-MD compliance in submissions and conduct.	New SOP created for Swissmedic regulatory compliance.	Head of Clinical Research

For more SOPs visit: Pharma SOP.