DPHARM 2024: eSource EHR Requirements

DPHARM's "How Do You Make Scaling eSource EHR a Reality?" session

Along its “New Approaches to Scale eSource EHR and Accelerate Clinical Development” track, Day 2 of DPHARM welcomed a presentation that sought to answer the question, “How Do You Make Scaling eSource EHR a Reality?”

Moderated by Amy Cramer, MMCi, BSN, director, data acquisitions, IDAR, data management and central monitoring at Johnson & Johnson Innovative Medicine, she was joined by Nadir Ammour, DDS, MBA, global lead, clinical innovation & external partnerships at Sanofi and
Joseph Lengfellner, senior director, CR informatics and technology, clinical research administration at Memorial Sloan Kettering Cancer Center to break down what the minimum requirements for eSource EHR/EDC middleware will be for early adopters and how this can help drive adoption at scale.

Cramer led off the session with a look at what has been successful globally thus far. The iHD eSource Scale Up Task Force—powered by the European Institute for Innovation through Health Data—required all its members to have experience doing live production studies in EHR in order to sponsor.

EHR to EDC (electronic health record to electronic data capture), also known as EHR as eSource, is able to streamline EHR data transfer for clinical research. This is done with patient consent and quality checks, while meeting regulatory eSource requirements; it combines data into either an EDC system or a sponsor’s study database, without replacing site staff or replicating data capture.

Though this is mostly a European group, the idea is for everything to be consistently global.

Cramer also pointed out that this presentation is meant to be vendor agnostic—the industry does not all use the same vendors, so none of the content that the speakers discuss relates to any one particular vendor.

Vulcan

Known as a global community with over 45 member organizations, it consists of patients, sponsors, sites, and big-tech companies within the clinical research space.

It is powered by four guiding principles:

1. Bridge clinical research and care
2. Strategically connect collaborators (by working with other organizations to help them reach their goals of interoperability)
3. Maximize collective resources
4. Enable tools and solutions for development

Minimal requirements for healthcare organizations, EHRs

Some of the standards required by healthcare organized, as determined by early adopters, include (but are not limited to):

• Planning to conduct a high number of clinical trials requiring high volume of data entry
• Structured data entry into electronic EHR that ensures compliance with published guidance to capture data provenance and have audited version tracking, plus availability in structured and coded form of vital signs and local lab data
• Use of a certified EHR system that meet regional requirements, such as ONC for example
• Adoption of FHIR
• Use of common coding ontologies (LOINC, SNOMED)

“We sat down in a room and we asked, what were the things that you found that made you successful for an early adopter,” Cramer explained. “This is really fascinating to me, that we did this in probably about three hours, and then we spent a day and a half working on the language, but the content itself was very clear to us in terms of what needed to happen.”

As for EHRs, they should provide FHIR access to essential clinical research data elements, such as LB, VS, and ConMed, while sharing a roadmap for exposing additional FHIR research resources; offer native functionality tailed for research purposes; enable the creation of research-specific forms with the EHR system; and they should have the ability to collect data from external sources (such as wearables).

“I think what’s interesting is the creation of research specific forms. We’re really focused on that highly-structured data to start, but we want to scale into other research data domains as well,” said Lengfellner. “For example, adverse event forms, toxicity forms: These are things that are available in EHR systems today that a lot of sites are not taking advantage of, so we can use this platform to talk about how to utilize this.”

EDC vendors

The session noted that electronic data capture vendors ought to implement a unified study capable of manual and EHR2EDC data entry; integrate lab ranges using FHIR resources for accuracy and consistency; and develop eCRF forms via EHR system integration among other requirements.

Meanwhile, among some of the highlights, those considered middleware EHR-EDC vendors should use an FHIR and EHR-agnostic approach; adhere to Vulcan implementation guidelines, limit data use for transferring to the trial sponsor exclusively

Reference

Cramer A, Ammour N, Lengfellner J.How Do You Make Scaling eSource EHR a Reality? September 18, 2024. DPHARM 2024. Philadelphia.