Supporting best practices

In 2023, the SCTO Platforms developed and shared five new tools and six publications with the clinical research community in Switzerland and beyond. Several tools for our new strategic focus on clinical research projects governed by the Human Research Ordinance (HRO) are currently underway and are expected to be made available online in 2024. The diverse activities of our SCTO Platforms contribute to the White Paper Clinical Research’s goal to develop innovative and dynamic clinical research approaches.

Highlights 2023

Eleven new tools and publications were developed for the clinical research community

Eleven new tools and publications in 2023

Routine Monitoring Visit and Close-Out Visit (RMV-COV) Report Template: This up-to-date and user-friendly monitoring report template can be used to report a routine monitoring visit and close-out visit.
Position paper: Monitoring in Non-Interventional Human Research Projects: This paper provides recommendations for implementing monitoring strategies for non-interventional human research projects.
Annual Safety Report for Investigator Initiated Trials (IITs): This template can be used to facilitate the annual safety reporting for IITs.
Serious Event Report Form for HRO Research Project: This template can be used to report serious events (SE) in HRO projects.
QMS BP: This publication series fosters continuous improvement and knowledge exchange about quality management systems and relevant best practices (QMS BP) in clinical research.
Easy Guide to Clinical Studies – A Practical Tool for Young Clinical Research Professionals: This publication appeared in IFAPP Today.
The new Federal Act on Data Protection (nFADP) Guidance for clinical trials: This short guide explains the relevance of the nFADP for clinical research projects.
Regulatory Affairs Watch, Issue 8: This issue focuses on experiences with the 2021 changes to the medical device regulatory framework.
sts_graph_landmark and redcaptools: These tools contain new statistical codes that facilitate the analysis of clinical research data.
2023 statistics programming competition: There were three grant winners in 2023.

Human Research Ordinance projects as a strategic focus

The SCTO Platforms form an interconnected, nationwide network that provides practical resources and innovative tools for clinical research professionals. During the 2021–2024 funding period, the SCTO Platforms are focusing on clinical research governed by Switzerland’s Human Research Ordinance (HRO). This includes observational clinical research as well as research with data and biological samples. Several projects are already underway, including expanding the Clinical Research Core Competencies Framework so that it align to the HRO and offering researchers training opportunities tailored to HRO projects.

Promoting networking across Switzerland

Each platform consists of a team with expertise and skills related to a key area of clinical research. Each Clinical Trial Unit (CTU) in our CTU Network runs a platform, and each platform includes staff from all CTUs. Collaboration within and between the platforms as well as with partner organisations and external experts promotes networking throughout the country and enables the platforms to be incubators of innovation.

All tools and publications from the SCTO Platforms are available on the Tools & Resources website.