With the rapid increase in adoption of electronic health records (EHRs), wearables, mobile devices, and other real-world data sources come opportunities to leverage them for evidence generation in clinical research, along with the promise of using big data analytics and seeking reductions in cost of research via streamlining processes, eliminating redundancies, and improving data quality. But all share common challenges in getting data from electronic source to regulators in ways that make it acceptable in regulated decision-making or, if not for regulated research, in getting the data into and out of useful research databases and data management systems. This is the “eSource” challenge.
Using CDISC Standards from the Start (EHRs, CDASH) has the promise of significantly decreasing the costs, time and resources for a clinical research study and to pave the way to SDTM, which will be required by FDA and PMDA this year… or to a useful database with high quality research data for reporting and/or developing publications.
The workshop will bring in elements to ground participants in the fundamentals of standards used to connect healthcare and research and to improve workflow for clinicians. It will also include new approaches to eSource and other relevant information related to ‘evidence generation’ for clinical research and other uses of healthcare data.
Elements related to Healthcare Link include:
- Introduction to Electronic Health Records and their use for clinical research
- Integrating the Healthcare Enterprise (IHE) profiles to streamline workflow for clinicians conducting research and to support data security and traceability from EHR to database
- Improved data quality and efficiencies through using electronic source data to streamline processes and eliminate transcription
New workshop elements:
- FDA eSource Federal Registry Notice Overview and relevant regulatory guidance
- Overview of challenges and opportunities in use of electronic source data ("eSource") for regulated research
- Description of the eSource Stakeholders Group with update on the latest developments
- Use cases that illustrate possible standards-based solutions to specific eSource challenges (e.g., data provenance)
Attendees will benefit from learning about, and discussing, the fundamental issues addressed in any eSource solution, and in learning the latest developments in this area.