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SOP for Swiss Ethics and BASEC Submissions and Communications

digi — Sat, 30 Aug 2025 00:38:46 +0000

SOP for Swiss Ethics and BASEC Submissions and Communications

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Swiss Ethics and BASEC Submissions and Communications SOP

Department	Clinical Research
SOP No.	CS/SWISS-ETHICS/190/2025
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 outlines procedures for preparing, submitting, and managing communications with Swiss Ethics Committees via the Business Administration System for Ethics Committees (BASEC). It ensures compliance with Swissmedic regulations, ICH GCP, and ethical governance requirements in Switzerland.

Scope

This SOP applies to all sponsor-led and investigator-initiated clinical trials conducted in Switzerland requiring submission to Swiss Ethics Committees through BASEC. It covers initial submissions, responses to ethics queries, substantial amendments, safety reporting, communications, and documentation archiving.

Responsibilities

Sponsor: Ensures complete and timely ethics submissions through BASEC and maintains oversight of communications.
Regulatory Affairs (RA): Prepares submission dossiers, manages BASEC portal entries, and tracks approval status.
Principal Investigator (PI): Provides site-specific documentation and ensures compliance with approved protocols.
Clinical Project Manager (CPM): Tracks submission timelines and ensures communication logs are maintained.
Quality Assurance (QA): Audits ethics submissions and ensures inspection readiness.

Accountability

The Sponsor’s Head of Regulatory Affairs is accountable for ethics submissions and communications. The PI is accountable for ensuring site compliance with approved ethics requirements.

Procedure

1. Preparation of Ethics Submission

Compile submission package including protocol, ICF, IB, recruitment materials, insurance certificate, and investigator CVs.
Translate documents into German, French, or Italian as required by the region.
Maintain Submission Checklist (Annexure-1).

2. Submission through BASEC

Submit the complete application electronically through the BASEC portal.
Record submission reference number and acknowledgment in Submission Log.

3. Ethics Committee Communication

Respond promptly to EC queries through the BASEC portal within defined timelines.
Maintain Communication Log documenting correspondence with ethics committees.

4. Substantial Amendments

Prepare amended documents with tracked changes.
Submit amendments through BASEC prior to implementation.
Record approvals in Amendment Log (Annexure-2).

5. Safety Reporting

Submit SUSARs and DSURs to ECs via BASEC as per timelines.
Ensure acknowledgment receipts are retained in TMF.

6. Documentation and Archiving

Maintain ethics approval letters, submission logs, and correspondence in TMF.
Archive ethics records for at least 10 years or per Swiss retention requirements.

Abbreviations

BASEC: Business Administration System for Ethics Committees
EC: Ethics Committee
Swissmedic: Swiss Agency for Therapeutic Products
ICF: Informed Consent Form
IB: Investigator’s Brochure
CTA: Clinical Trial Application
PI: Principal Investigator
RA: Regulatory Affairs
QA: Quality Assurance
CPM: Clinical Project Manager
TMF: Trial Master File

Documents

Submission Checklist (Annexure-1)
Amendment Log (Annexure-2)
Communication 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: 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 ICF	BASEC	Under Review	Neha Sharma

Annexure-3: Communication Log

Date	Committee	Topic	Response	Owner
12/08/2025	BASEC	Request for clarification on SAE reporting	Response provided	Sunita Reddy

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for Swiss ethics and BASEC submissions and communications.	New SOP created for regulatory compliance in Switzerland.	Head of Clinical Research

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SOP for ClinO and ClinO-MD Compliance in Submissions and Conduct

digi — Fri, 29 Aug 2025 12:55:38 +0000

SOP for ClinO and ClinO-MD Compliance in Submissions and Conduct

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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

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

2. Submissions to Swissmedic and BASEC

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

3. Trial Conduct and Monitoring

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

4. Safety Reporting

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

5. Protocol Amendments

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

6. Archiving

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