Real-time Perspectives on the Transition to eSource: SCDM Best Practice Consensus Recommendations for Implementation and Scalability

The transition from traditional to modern data collection, in the form of eSource, has spawned an entire new ecosystem of approaches and vendors. This has created a complex web of considerations that leave many clinical research stakeholders unsure of where to start. A study from the Society of Clinical Data Management (SCDM) eSource Implementation Consortium, published in Contemporary Clinical Trials Communications in December 2024, found there were 36 steps research sites needed to traverse before they could even get started with eSource- all of which were associated with their own challenges. 1 Scalable implementation relies on the clinical research ecosystem, in collaboration with regulators, coming together to overcome these barriers. To this end, SCDM hosted a series of workshops and meetings in 2024, bringing leading subject matter experts from across the clinical research ecosystem together to share their knowledge, insights, and case studies. The initiative included three working groups, which focused on site readiness, contract readiness, and technological readiness. They were followed by a roundtable discussion, which reviewed and discussed the working groups' findings, the challenges and, crucially, the potential solutions of eSource implementation. This document summarizes those talks and sets out a range of best practices, all aimed at building a consensus that can act as a foundation for the wide-scale adoption of eSource clinical trial data collection and transfer across the industry. 1 Cramer, A.E., King, L.S., et al (2024). Defining methods to improve eSource site start-up practices. Contemporary Clinical Trials Communications, 42, 101391.