For clinical research stakeholders, implementing and scaling electronic source date (eSource) is a priority. With participation from MSK, a number of Society of Clinical Data Management (SCDM) working groups have collaborated on a paper outlining consensus recommendations on eSource best practices. Published in September 2025 n the Journal of the Society for Clinical Data Management, the paper provides valuable guidance for clinical research stakeholders who are unsure of where to begin.
Previously, the SCDM eSource Implementation Consortium outlined 36 steps research sites should take before initiating the transition to eSource in a paper published in Contemporary Clinical Trials Communications in November 2024. However, each step was associated with challenges, and methods for addressing obstacles were not clearly defined. Additionally, while the U.S. Food and Drug Administration has provided a general framework for implementing eSource and highlighted the benefits of Health Level-7 (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standards, no standard guidelines are currently available.
To bridge this knowledge gap, the SCDM convened three working groups for a series of workshops and meetings in 2024. Focusing on the site, contract, and technological readiness challenges of eSource implementation, the groups shared knowledge, insights, and case studies, and came to a consensus on best practices.
“The paper was authored by leading clinical research experts from four pharmaceutical companies, two academic sites, a clinical research organization, and a technology vendor. It serves as a useful guide for implementing direct data exchange technologies,” said Mike Buckley, Associate Director of Product of Clinical Research Informatics and Technology (CRIT) at Memorial Sloan Kettering Cancer Center (MSK), Co-Founder and 2017 Co-Chair of the Society for Clinical Data Management eSource Implementation Consortium and co-author of the paper. “Overall, the working groups concluded that the optimal approaches for operationalizing and scaling eSource EHR dataflows occur when the site or the sponsor identifies the preferred technology.”
MSK was featured as a case study of site-identified technology in action. Since May 2023, MSK has been collaborating with technology vendor IgniteData to transfer a high volume of MSK’s clinical research data using Archer, IgniteData’s system-agnostic tool. The new system has significantly reduced the time and effort required for data entry in both investigator-initiated and commercially sponsored studies, with productivity increased by 58% and data entry errors reduced by 99%.
Read the paper. Learn more about how the activities of the MSK CRIT team bring innovation benefits to industry sponsors and regulators and foster clinical research innovation globally. For additional background on the global drive to improve clinical research data management, read these: