№ lp_2_3_27304
File format: docx Character count: 10167 File size: 283 KB
The document outlines procedures for the documentation and reporting of adverse events (AEs) and serious adverse events (SAEs) in clinical trials involving medicinal products (IMP), transplant products (TpP), gene therapy (GT), and genetically modified organisms (GMO) in accordance with ClinO regulations.
Gültig ab: 04.07.2020
Note: Author
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The product description is provided for reference. Actual content and formatting may differ slightly.
Packaging and labelling IMP
Note: Year
Subject: Clinical Trial Procedures
Document Type: Standard Operating Procedure
Organization / Institution: [group/institution]
Target Audience: Clinical trial team, pharmacy staff
Version Number: 1
Clinical Protocol Template for ClinO, Chapter 4 «Other Clinical Trials»
Year: 2025
Region / city: Switzerland
Theme: Clinical Trials
Document Type: Protocol
Institution / Organization: Swiss Ethics
Author: Swiss Ethics
Target Audience: Researchers, Principal Investigators, Ethics Committees
Validity Period: Ongoing
Approval Date: 16.09.2024
Date of Changes: 18.06.2025
Notification of the completion of a clinical trial (ClinO), a clinical trial of medical device (ClinO-MD) or of a research project (HRO) to the Ethics Committee
Year: 2023
Region / city: Switzerland
Topic: Clinical trials, medical devices, research projects
Document type: Notification
Organization / institution: Ethics Committee
Author: Swiss Ethics Committee
Target audience: Researchers, ethics committees, medical professionals
Period of validity: Until completion of the study
Approval date: N/A
Date of modifications: N/A
Topics: AEsSAEs IMP ClinO