SCDM eSOURCE IMPLEMENTATION CONSORTIUM

Leading biopharmaceutical companies, academic medical centers, and healthcare technology providers have partnered to create an eSource Implementation Consortium (Consortium) with the vision of enabling a faster and more efficient digital exchange of clinical research source data from academic medical sites to industry sponsors, through Electronic Health Records (EHR) to Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS). The Consortium seeks to streamline existing data transfer processes to free up site staff to focus on patient touchpoints.

The mission of this academic-industry eSource Implementation Consortium is to agree upon standardization of clinical research data sets that will enable faster adoption of direct data transfers by academic sites and industry sponsors. We will implement this mission by leveraging existing clinical research HL7^® Fast Healthcare Interoperability Resources (FHIR^®) standards where available.

The eSource Implementation Consortium’s value proposition is bringing together academia and biopharmaceutical companies, along with EHR vendors, EDC vendors, and technology providers. The Consortium will establish agreed upon methods of clinical trial data transfer, define best practices that can be scaled up across the clinical research enterprise, and consistently share progress with the FDA Center for Drug Evaluation and Research (CDER) Health Information Technology (IT) Board, and other regulatory authorities.

The eSource Implementation Consortium was established in 2017 under the auspices of the Society for Clinical Data Management (SCDM), and comprises five academic medical centers: 1) Memorial Sloan Kettering Cancer Center (MSK), 2) Yale School of Medicine, 3) Duke University School of Medicine, 4) Washington University-St. Louis, School of Medicine and 5) one pending academic site to be confirmed; and five biopharmaceutical firms: 1) Novartis, 2) Eli Lilly, 3) Bristol-Myers Squibb, 4) Pfizer, and 5) Merck. These ten members, along with At-Large members Forte Research Systems and Health Level Seven International (HL7^®), comprise the Steering Committee and set mutually agreed upon priorities and business objectives for the Consortium, manage general operations, and execute key working group deliverables rapidly. The Consortium has also engaged with the US FDA and plans to engage with other global regulatory agencies and health authorities.

With this announcement, the Consortium is now open to all academic, technology and industry sponsor participation. If your company or institution would like to become part of the Consortium, please email Sdangelo@scdm.org expressing your interest.

The Consortium’s aspires to develop Data Exchange Specifications for core safety domains and various Therapeutic areas efficacy domains. The first key working group deliverable is to develop Local Lab Data Exchange Specifications. The Consortium has defined a common core data set using Logical Observation Identifiers Names and Codes (LOINC) standards and will operationalize data transfer from local labs using FHIR^® APIs and JavaScript Object Notation (JSON).