Data integrity is paramount for the credibility and reliability of clinical research projects. It is essential to ensure that health-related data are assessed and recorded by a robust electronic system that meets high quality standards. When electronic health record (EHR) systems are used for source data in clinical trials, they must fulfil special regulatory requirements in order to be compliant with ICH-GCP, the federal Human Research Act (HRA) and its ordinances on clinical trials (ClinO, ClinO-MD), cantonal data protection laws, and internationally recognised standards.
This guidance provides an overview of the requirements an EHR system should meet to ensure that the data recorded in it are valid and reliable for use in clinical research projects. It also outlines EHR system requirements that allow source data to be verified in a manner that is compliant with data protection laws.
The guidance document might be of use for several groups:
- sponsors and sponsor-investigators attempting to assess the compliance of institutional EHR systems;
- monitors supporting study sites as they evaluate source data assessment;
- healthcare institutions seeking to update or replace their current EHR system in order to keep apace with changing requirements for handling data complexity and for meeting quality standards.