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