Validation of data transfers from EHR to EDC
The TransFAIR virtual study was designed within EHR2EDC to test and validate the capability of our methodology, data extraction and mappings, governance and technical solution for transferring data from EHR to EDC systems.
This was a prospective comparison of a new EHR2EDC for data acquisition from hospital EHRs versus manual entry.
MyStudy Design – Mirror Studies
- Six protocols from three pharma companies (AstraZeneca, Janssen, Sanofi)
- Four categories of health data (demographics, vital signs, laboratory and concomitant medication)
- Hospitals from three countries: AP-HP (France), 12 Octubre (Spain), IRST (Italy)
- 44 patient consents collected
- >11000 data points automatically transferred
The data extraction protocols were approved by the ethics committee at each hospital site before connections were made between their EHR systems and the InSite clinical research platform that had implemented the EHR2EDC specifications, and then on to the EDC system.
The EHR2EDC results in a nutshell
37% of patient data were successfully transferred!
Interoperability mapping
The first validated set of the most commonly collected data in clinical trials was mapped, Common Information Model (CIM) and HL7 Fast Health Interoperability (Resources (FHIR) based interoperability profiles developed
Regulatory
ISO Good Clinical Practice (GCP) and Regulatory compliance for regulated trials
Data governance
Principles, code of practice and Standard Operating Rules to support hospitals to conform to applicable GDPR regulations
Technical module
Tested and validated
Validation study
Multi-centric, multi-sponsor validation study (TransFAIR) successfully completed at the partner sites
TransFAIR Study Conclusions
- Results have shown that data can be successfully transferred from EHR to EDC, using the EHR2EDC specifications and demonstrated via the InSite platform
- EHR2EDC data mapping is reusable across studies, allowing for cost-efficient interoperability and offer to participating hospitals an ability to interact with different sponsor companies.
- Clinical trials with high volume of local laboratory data are best for taking advantage of using EHR2EDC capability.
- The following areas of improvement have been identified, and would enhance the data transfer capability significantly:
- Robust EHR data quality measures will significantly increase the value of using EHR data for retrospective or observational prospective studies, or for using EHR data as a comparative arm.
- Education of hospital staff about the value of EHR data for research will reduce the proportion of data elements of value in clinical research that are still captured on paper.
- Improve availability and capture of concomitant medication in EHRs.
- Aligning eCRF design with common EHR structure, meaning designing eCRFs and study data bases to collect data from EHRs as opposed to presently designed for manual transcription.
