SCTO Tools & Resources Navigator *
Search Results (17)
Sort by: 10 per page
HRA Ordinance Revision 2024/2025: Comparing old and new requirements
Copy Link
Regulatory Affairs | Human Research Act - HRA | Education & Training
This document provides a practical overview of key changes introduced in the revised HRA ordinances.
See Links & Downloads
Downloadable Documents:
HRO Lunch Session Material - BASEC: A practical walk-through for HRO projects
Copy Link
Regulatory Affairs | HRO | Education & Training
Practical guidance on observational study submission through the BASEC portal in line with HRO Chapter 2 and a further use project according to HRO Chapter 3.
See Links & Downloads
Downloadable Documents:
HRO Lunch Session Material - Mastering Consent: Key insights into general and informed consent for HRO projects
Copy Link
Regulatory Affairs | Consent | Education & Training
Overview of the legal and ethical requirements for the secondary use of data and samples, and how and when general consent can be used
See Links & Downloads
HRO Lunch Session Material - Quality: Law, practice and common hurdles
Copy Link
Regulatory Affairs | HRO | Education & Training
Legal basis of quality aspects of a research project with examples on how to keep the quality of projects high.
See Links & Downloads
Online seminar: HRA ordinances - what has changed?
Copy Link
Regulatory Affairs | Human Research Act - HRA | Education & Training
Presentation by swissmedic and Swissethic on the overview of the most significant changes in the new HRA ordinances in 2024 with a particular focus on the Clinical Trials Ordinance (ClinO) and Human Research Ordinance (HRO).
Regulatory Affairs (RA) Watch 1 - EU GDPR
Copy Link
Regulatory Affairs | Data protection | Article
Issue on data protection in human research
See Links & Downloads
Downloadable Documents:
Regulatory Affairs (RA) Watch 10 – ICH GCP E6(R3): How it impacts clinical research in Switzerland
Copy Link
Regulatory Affairs | Document Management | Article
Impacts of the new ICH GCP E6(R3) on clinical research in Switzerland
See Links & Downloads
Downloadable Documents:
Regulatory Affairs (RA) Watch 2 – Medical Devices
Copy Link
Regulatory Affairs | Human Research Act - HRA | Article
Issue on Regulatory changes coming from the EU and the ongoing revisions of Swiss laws regarding medical devices.
See Links & Downloads
Downloadable Documents:
Regulatory Affairs (RA) Watch 3 – General Consent
Copy Link
Regulatory Affairs | Consent | Article
Deep dive in the general consent implementation in Switzerland and the challenges around it
See Links & Downloads
Downloadable Documents:
Regulatory Affairs (RA) Watch 4 – Medical Registries
Copy Link
Regulatory Affairs | Human Research Act - HRA | Article
medical registries (MRs) as a research tool what are the opportunities and the challenges
See Links & Downloads
Downloadable Documents:
* Contains only tools and resources developed by the SCTO. SCTO CRC Network services are not included.