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Regulatory Affairs (RA) Watch 7 – Data privacy and data sharing in clinical research
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Regulatory Affairs | Data protection | Article
DATA PRIVACY AND DATA SHARING WITHIN THE REGULATORY FRAMEWORK GOVERNING HUMAN, HEALTH-RELATED
RESEARCH IN SWITZERLAND
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Regulatory Affairs (RA) Watch 8 – Experiences with 2021 changes to MD regulatory framework
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Regulatory Affairs | Human Research Act - HRA | Article
NAVIGATING THE 2021 CHANGES TO THE MEDICAL DEVICE REGULATORY FRAMEWORK
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Regulatory Affairs (RA) Watch 9 – Innovation in clinical research: Decentralised and complex trials
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Regulatory Affairs | Study Management | Article
DECENTRALISED AND COMPLEX CLINICAL TRIALS: SHAPING THE FUTURE OF CLINICAL RESEARCH. Opportunities and challenges
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Revision of the Human Research Act (HRA) ordinances – Impact on projects approved before 1 November 2024
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Regulatory Affairs | Human Research Act - HRA | Education & Training
The revised HRA ordinances came into force on 1 November 2024, with the new transparency rules taking effect on 1 March 2025. This document, prepared by the SCTO Regulatory Affairs Platform, outlines the impact of the revised ordinances on projects approved prior to 1 November 2024.
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Risk Assessement Form, Video and User Instruction
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Quality Management | Risk Management | Quality Documents
Risk Assessment Form, including user instruction and video, for sponsor-investigators to ensure potential risks of a clinical research project are addressed in line with current GCP requirements.
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Risk-Based Monitoring Score Calculator
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Quality Management | Risk Management | Risk Score Calculator
This interactive tool helps research teams assess monitoring needs, generate RBM scores, and ensure efficient, high-quality trial oversight.
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Routine Monitoring Visit and Close-Out Visit (RMV-COV) Report Template
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Monitoring | Human Research Act - HRA | Quality Documents
This up-to-date and user-friendly monitoring template can be used to report a combined routine monitoring visit and monitoring close-out visit.
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SAE or Device Deficiency Report Form for IMDs
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Safety | Document Management | Form
This document can be used for Serious Adverse Event (SAE) or Device Deficiency (DD) reporting in Clinical Trials with an Investigational Medical Device (IMD).
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SAE or Device Deficiency Report Form for IVDs
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Safety | Document Management | Form
This document can be used for Serious Adverse Event (SAE) or Device Deficiency (DD) reporting in Clinical Trials with an In Vitro Diagnostic Medical Device (IVD).
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SAE Report Form for IMPs
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Safety | Document Management | Form
This document can be used for Serious Adverse Event (SAE) notifications in Clinical Trials with an Investigational Medicinal Product (IMP).
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