We have defined data conversion mappings rules. These enable hospitals to retain use of their own data model while being able to convert their data to a common standard to foster collaboration amongst healthcare organisations. Mapping to a secondary data model to seamlessly collaborate with industry is also facilitated. The principles used are underpinned by a highly resilient, EHRs and EDC agnostic data model, while maximizing reusability across studies and avoiding extensive, study by study re-validation work.

These mappings have been implemented by the project technical project partner TriNetX as a research platform and validated through a multi-protocol synthetic study (TransFAIR). They are now available for open access use.

Data governance

We have defined GDPR-compliant Standard Operating Rules for how hospital EHR staff, investigators and research platform staff need to process the EHR data being used in EHR2EDC. These rules require that all steps of the processing have a GDPR legal basis applicable to Special Category data, that suitable information security safeguards are in place and that staff adhere to a code of conduct.

Data quality

We can assess and benchmark the data quality (DQ) of hospital EHR data to ensure that it meets sufficient standards to be offered to investigators to import into EDC systems and use as part of their clinical study. Where we find data quality issues we can guide hospitals on how best to improve their DQ.

System quality

We have reviewed carefully the guidelines developed by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the reuse of Electronic Health Record data being used as a source (known as eSource) of regulated clinical trial data. These require evidence of certain quality characteristics of EHR systems being used as eSource. We have cross-referenced these with other international standards on EHRs and EHR systems, and from this developed a profile of metadata that should accompany clinical data in order to have transparency about the trustworthiness of the data values. These have in turn been factored as EHR system and clinical research platform quality criteria and test plans.

  • We can now assess and certify the hospital EHR systems to be compliant with regulatory requirements for eSource.
  • We can assess and certify clinical research platforms for eSource, GDPR compliance and acceptable information security measures.

Regulatory framework

We have worked with medicines regulators to help them to understand the tremendous opportunity that exists with reusing routinely collected electronic health record information as a data feed into clinical trials systems, the methods we have developed and our quality processes for ensuring the data can reliably be used for regulatory decision-making. We have received positive feedback from regulators about the approach we taken, and they intend to work closely with us as we progress through from the original EHR2EDC project to the Champion Programme and other R&D project continuations.