Our innovative tools and resources to facilitate clinical research are freely available to the clinical research community in Switzerland and beyond.
Our innovative tools and resources to facilitate clinical research are freely available to the clinical research community in Switzerland and beyond.
Logs all reported adverse events experienced by participants. Aids in safety monitoring and regulatory reporting.
Wednesday, 11 September 2024, 12h00 – 13h00
This seminar session is part of a lunch seminar series, which offers brief overviews and room for questions on important topics related to observational studies (HRO projects). Find out more about the whole seminar series "Facts and pitfalls for observational studies - how to plan and conduct HRO projects" by following the link below.
The Clinical Research Careers website provides quick access to relevant career progression programmes and career information in Switzerland.
The detailed and interactive Clinical Research Core Competencies Framework lists the knowledge, skills, and attitudes that clinical research teams need to run clinical trials.
Wednesday, 17 April 2024, 12h00 – 13h00
In this seminar session, you will learn about the essentials of data procurement, governance, and protection. We will talk about the most important aspects regarding the new data protection law and will give practical insights into how data are handled at different university hospitals.
Wednesday, 13 November 2024, 12h00 – 13h00
Data storage, data sharing, and contracts around data and samples – many researchers are not sure about what to handle how. In collaboration with the Swiss Personalized Health Network (SPHN), this session highlights common practices, possibilities and must-knows, focusing on data storage and data sharing.
Wednesday, 25 June 2025, 12h00 – 13h00
This two-part session highlights the principles and relevance of de-identification of health-related personal data in human research and provides insights into the operational practices of proper de-identification. This seminar session is part of a lunch seminar series, which offers brief overviews and room for questions on important topics related to observational studies (HRO projects).
The interactive Easy GCS provides relevant information and practical guidance on how to plan and conduct a clinical study in compliance with regulations.
The EHR Systems Study Site Assessment Template can be used to assess the regulatory conformity of electronic health record systems that host the source data for clinical research projects.
Wednesday, 27 March 2024, 12h00 – 13h00
This seminar session will provide you with insights on how to get the mandatory ethics approval for your observational study. You will learn about retrospective and prospective projects, participant information and consent, and will get practical examples on how to submit your application.
This document provides a practical overview of key changes introduced in the revised HRA ordinances. Prepared by the SCTO Education Platform, it supports sponsors, investigators, and study staff in understanding and applying the updated regulations. Please note that this summary is for guidance only—refer to the official HRA ordinances for legally binding information and contact your local CTU or competent authorities for project-specific advice.
Tracks receipt, dispensing, and return of Investigational Medicinal Product/Device. Ensures accurate accountability at both site and participant levels.
Wednesday, 1 October 2025, 12h00 – 13h00
This seminar session is part of a lunch seminar series, which offers brief overviews and room for questions on important topics related to observational studies (HRO projects).
Wednesday, 2 October 2024, 12h00 – 13h00
This session provides an overview of the legal and ethical requirements for the secondary use of data and samples, and how and when general consent can be used. It also addresses scenarios where general consent is not available and provides alternative methods for obtaining participant consent.
The up-to-date and user-friendly Monitoring Close-Out Visit (COV) Report Template can be used to report a close-out visit.
The up-to-date and user-friendly Monitoring Plan Template can be used to set up a monitoring plan.
The up-to-date and user-friendly Monitoring Site Initiation Visit (SIV) Report Template can be used to report a site initiation visit.
The up-to-date and user-friendly Monitoring Visit Report Template can be used to report monitoring visits.
Documents protocol deviations and corrective actions. Provides rationale and context for trial irregularities for audit trails.
This free online safety training enables you to consolidate or refresh your knowledge of patient safety and reporting issues in clinical research.
Monday, 28 October 2024, 12:00 – 13:00
presize is an R package providing a range of functions for performing precision-based sample size calculations.
Wednesday, 29 May 2024, 12h00 – 13h00
In this seminar session, you will learn about «quality in a nutshell». We will start with the respective law and then give practical tips and examples on how to keep the quality of your project high.
redcaptools is an R statistics package with tools for simplifying data exports with REDCap into single forms for easier use.
Wednesday, 8 May 2024, 12h00 – 13h00
This seminar session gives insights about common pitfalls when working with large sets of clinical patient data and biological samples. We will look at practical tips for planning projects and research questions, up to regulatory requirements and real-life examples.
Wednesday, 7 May 2025, 12h00 – 13h00
This seminar session will provide you with information about the aim as well as the creation and use of registries in human research. Furthermore it will provide experiences from a well-established example registry. This seminar session is part of a lunch seminar series, which offers brief overviews and room for questions on important topics related to observational studies (HRO projects).
Wednesday, 19 November 2025, 12h00 – 13h00
This seminar session consists of two parts. The first will examine the Ethics Committee’s perspective on the requirements for such projects, while the second will outline the objectives and key features of concrete projects and provide practical guidance on preparing, conducting, and completing them.
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.
The user-friendly Risk Assessment Form can be used to make a step-by-step assessment of a clinical research project's potential risks; it is in line with current GCP requirements.
The Risk-Based Monitoring (RBM) Score Calculator is a web-based questionnaire that helps you identify the best monitoring strategy for your clinical trial.
The up-to-date and user-friendly Routine Monitoring Visit and Close-Out Visit (RMV-COV) Report Template can be used to write a combined routine monitoring visit and close-out visit report.
The interactive Safety Expert Finder helps you connect with experts who can support you in the safety management of your clinical research study.
This set of comprehensive safety reporting forms addresses all aspects of safety reporting for clinical research projects.
Wednesday, 4 December 2024, 12h00 – 13h00
This session provides an insight into the most important aspects of biobanking for HRO projects. In collaboration with the Swiss Biobanking Platform (SBP), it presents common practices in different hospitals and gives practical and organisational tips for setting up and maintaining biobanks.
secuTrialR is an open-source R statistics software package that makes it easier to work with secuTrial®.
selcorr calculates (unconditional) post-selection confidence intervals and p-values for the coefficients of (generalised) linear models.
This lunch seminar series offers brief overviews and room for questions on important topics related to observational studies (HRO projects). As researchers, you can shape the focus of the individual events by submitting your specific questions in advance. This ensures that the sessions are tailored to your needs.
sse is an R statistics package with flexible tools for calculating sample size and presenting the statistics that relate power, sample size, and the assumptions made.
sts_graph_landmark is a Stata programme for avoiding survival bias that creates landmark analysis Kaplan-Meier curves, complete with risk tables.
Tracks delegation of trial-related duties from the Investigator/Sponsor to authorized staff. Ensures accountability and compliance with GCP.
Log details of monitoring visits at the study site(s). Supports oversight and documentation of site interactions.
Templates facilitate organized tracking of essential trial documents and all site-related communications. Support compliance, transparency, and effective site management throughout the study.
Tracks participant screening outcomes, enrolment status, and identifiers. Supports recruitment tracking and subject confidentiality.
Documents SIV agendas and attendees along with their training status. Verifies site readiness and staff preparedness before trial start.
Records training activities and qualifications of trial personnel. Ensures all staff are trained in protocol and regulatory requirements.