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.
This template helps study sites check the regulatory conformity of their EHR systems that host the source data for clinical research projects. In addition, it enables sponsor-investigators to assess whether EHR systems at study sites are suitable for their studies.
This template is aimed at Swiss study sites and Swiss sponsor-investigators who perform academic clinical research.
This template was developed by the SCTO’s Regulatory Affairs Platform and first published in September 2020.
Electronic medical records are increasingly replacing paper-based health records of patients. For clinical research, EHR systems provide the source data of patients participating in clinical research projects.
Thus, EHR systems have to fulfil special regulatory requirements to be compliant to ICH GCP guidelines and data protection laws. However, according to a survey conducted by the SCTO’s Regulatory Affairs Platform in 2019, many Swiss academic clinical research sites are not fully aware of these regulatory requirements. To address this problem, members of the Regulatory Affairs Platform created this study site assessment template for EHR systems.
This template is licensed under CC BY-NC 4.0. Its content can be shared and adapted as long as you follow the terms of the license. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc/4.0/.
The Guidance for electronic health record (EHR) system requirements in Switzerland complements this template. You can download the guidance document as a PDF.
In early 2021, the RA Platform conducted an online survey outlining
EHR system use, experience, and needs of clinical research professionals in
Switzerland. You can download the final report as a docx.
Feel free to contact us with any questions or feedback related to this resource!