Issue 5, March 2021
One year of COVID-19, first lessons learnt
Read the online version of RA Watch 5 on one year of COVID-19
Dr Séverine Méance, Centre Hospitalier Universitaire Vaudois, CTU Lausanne
The email newsletter Regulatory Affairs Watch (RA Watch) aims to reach a wide, national audience: human research professionals, investigators, (potential) sponsors, regulators, members of ethics committees, professional organisations and patient associations.
RA Watch shares, at regular intervals, news of a scientific and regulatory nature, from Switzerland and abroad: articles, events and publications. Furthermore, each issue features a deep dive on a particular topic, accompanied by views and opinions of different organisations. The newsletter is published in English only.
The newsletter was launched in April 2019 by the Regulatory Affairs Platform. Learn more about their activities in the fact sheet below.
Issue 4 on medical registries, October 2020, online version
Issue 3 on General Consent, March 2020, online version
Issue 2 on medical devices, October 2019, online version
Issue 1 on EU GDPR, April 2019, online version
More and more frequently, electronic health record (EHR) systems provide source data for case report forms (CRFs) in clinical trials and research projects. These EHR systems must fulfil special regulatory requirements to be compliant with ICH-GCP guidelines and data protection laws. However, according to a survey conducted by the SCTO’s Regulatory Affairs (RA) Platform in 2019, many Swiss academic clinical research sites are not fully aware of the regulatory requirements.
To address this problem, members of the platform created a study site assessment template for EHR systems. On the one hand, this template is intended to help study sites check the conformity of their EHR systems that host the source data for clinical trials and research projects. On the other hand, it should enable sponsor-investigators to assess the suitability of the EHR systems used by study sites involved in their studies.
The template is aimed at Swiss study sites as well as Swiss sponsor-investigators who perform academic clinical research. With this template, the RA Platform aims to provide general assistance and help sites keep apace with digital developments and thus remain competitive and attractive clinical research locations.
Because the template is freely accessible to third parties outside the SCTO, it is important to follow the general instructions on the template’s cover page:
EHR System Study Site Assessment Template
Summary of the online survey outlining EHR system use, experience, and needs of clinical research professionals in Switzerland (conducted in early 2019):
Electronic health record systems at Swiss clinical trials sites: Usage, experience, and needs
Regulatory affairs is a relatively new professional field. It emerged in the 1980s, when governments worldwide became compelled to better protect the public. Such protection includes ensuring that all medicines reaching society are optimally safe and effective. Regulatory professionals were developed to integrate sound regulatory practices into projects from start to finish, keeping them on the right legal track.
In the realm of clinical research, they assist their peers with clinical trials applications, from early days, ensuring that all the documents and processes accompanying a project are in place and are of the quality required. Regulatory affairs professionals assist in reviewing study plans (protocol) and preparing submissions to national authorities, amending as needed, placing the trial in a registry, and following it through with the final study reports. All documents must be reviewed, complete, scientifically accurate, in regulatory compliance, and presented so as to facilitate the review and approval process of the ethics committees and – if needed – of the competent authorities.
Would you like to know how the experts in the Regulatory Affairs Platform are channeling their efforts? For more information, consult the fact sheet below.