Austin, TX – 14 January 2016 – The Clinical Data Interchange Standards Consortium (CDISC) announced today the establishment of the “eSource Stakeholders Group,” an open, inclusive forum which will provide coordination and focus to the increasing community of stakeholders interested in realizing the benefits of using eSource, also known as electronic source data, in clinical trials and meeting regulatory requirements for eSource data, provenance and electronic records. This news follows the FDA’s announcement in June 2015 encouraging organizations to propose demonstration projects, the September 2013 FDA Guidance encouraging the use of electronic source data in the conduct of clinical investigations, and, most recently, the updated Electronic Health Record (EHR) eSource webpage on the FDA-CDER website.
“The use of electronic health records has the potential to foster efficiency and further innovation in regulated clinical research,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “Demonstration projects that test and evaluate the performance of end-to-end EHR-to-EDC single-point data capture approaches are an important source of information as we collectively work to ensure the quality of data from electronic source to electronic regulatory submission.”
CDISC is working closely with the FDA and other innovative organizations to demonstrate benefits for clinical research of data sourced electronically from EHRs and related clinical technologies. Collaborative efforts between CDISC and the FDA, which began in 2004, led to the publication of an eSource Data Interchange document in 2006. Today's announcement continues that work. Recent activities and informational meetings indicate interest from a broad range of stakeholders, including biopharmaceutical companies, academic medical centers, EDC vendors, and clinical research organizations.
“Implementing eSource at clinical research sites allows the capture and use of data needed for clinical research studies directly from the EHR or other eSource tools, eliminating transcription and duplicate data entry and thus providing improved quality, speed and efficiency,” stated Dr. Michael Ibara, CDISC Head of Digital Healthcare. “While EHRs are now widely used, not enough has been done to utilize eSource data effectively for clinical trials, even with the final FDA guidance from 2013. CDISC sees the eSource Guidance and the updated FDA-CDER EHR eSource webpage, along with our mutual effort through the establishment of the eSource Stakeholders Group, as ways to effectively encourage organizations to learn how best to reap the benefits of using electronic source data and standards-based processes for clinical trials.”
Parties who are working on a demonstration of electronically sourced data for clinical trials, and those parties with a strong interest in furthering this work, are invited to attend the upcoming eSource Stakeholders Forum, planned for 18 March 2016 in Washington, DC area. The eSource Stakeholders Group will highlight the benefits and challenges of implementing eSource processes, share knowledge of how various organizations are pursuing implementation, and work with one another to find best practices to address those challenges. This group will meet regularly with the FDA and other interested parties, sharing information and lessons learned to encourage a broad understanding of the eSource effort and the adoption of practices, standards and tools that contribute to effective implementations.
CDISC is a 501(c)(3) global non-profit charitable organization that streamlines research and enables connections to healthcare through the development of clinical research data standards. CDISC has developed a suite of standards to support clinical research from protocol through analysis and reporting, including therapeutic are specific standards for over 25 disease areas. CDISC standards make it possible for data to speak the same language, empowering simple data collection and private sharing that makes the most of the valuable information offered by patients participating in research studies around the globe. Using CDISC standards from the start of studies enables Smarter Research to Unlock Cures, saving ~60% overall in terms of time and resources to conduct research. CDISC is the patient’s advocate, creating therapeutic area data standards that advance medical product development and various types of clinical research.