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FACT SHEET Patient and public involvement (PPI)
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Patient and public involvement (PPI) | Study Management | Publications
This Fact Sheet explains where and when PPI is possible and who should be involved.
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GGOP version 3
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Auditing | Study Management | Publications
The GGOP defines common clinical-research standards used across the SCTO CTU Network to ensure participant safety, high-quality operations, and efficient use of academic resources.
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Guide for researchers to address patient and public involvement (PPI) in clinical trials
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Patient and public involvement (PPI) | Study Management | Publications
This guide helps researchers identify meaningful opportunities to involve patients and the public in their studies.
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Guideline for Risk-Based Monitoring
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Quality Management | Risk Management | Publications
These guidelines outline risk-based monitoring for clinical trials and help identify the appropriate monitoring risk category for each study.
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Guidelines on safety reporting for Cat A trials
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Safety | Document Management | Guideline
This guidance document provides practical recommendations for fulfilling the regulatory requirements and safety reporting obligations applicable to Category A clinical trials on Investigational Medicinal Products (IMPs) in Switzerland.
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harmBounds
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Statistic and Methodology | R package & statistical code
harmBounds R Package calculates stopping probabilities, defines stopping boundaries, and produces plots for safety monitoring using a simple event-based approach. The package supports safety interim analyses during trial conduct. Further development toward a broader vignette on safety interim analyses is being considered.
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HRA Ordinance Revision 2024/2025: Comparing old and new requirements
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Regulatory Affairs | Human Research Act - HRA | Education & Training
This document provides a practical overview of key changes introduced in the revised HRA ordinances.
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HRO Lunch Session Material - BASEC: A practical walk-through for HRO projects
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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.
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HRO Lunch Session Material - Clinical data from 800'000 patients unlocked: The SPHN Federated Clinical Routine Dataset
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Education & Training | Data sharing | Education & Training
This seminar session will provide an overview of the SPHN Federated Clinical Routine Dataset, a remarkable resource designed to give healthcare researchers access to vast amounts of patient data for further use research according to HRO chapter 3.
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HRO Lunch Session Material - Data governance and protection: How to navigate the regulatory jungle
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Education & Training | Data governance | Education & Training
Essentials of data procurement, governance, and protection. The most important aspects regarding the new data protection law and practical insights into how data are handled at different university hospitals will be presented
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