ABOUT THE PROJECT
The global EHRCR Functional Profile Project is a collaborative effort to expand and adapt the functionality of EHR and associated systems, networks, and processes to support clinical research. The project is aimed at developing a Functional Profile that identifies critical capabilities for the conduct of clinical research utilizing EHR systems and establishes conformance to the HL7 EHR Functional Model and the Q-Rec EHR Certification Criteria.
The main project objectives are:
- To ensure that EHR systems, when used to collect source data in support of claims made regarding the safety and efficacy of new medical products, can be trusted by regulatory authorities to be a ‘reliable’ data source.
- To further expand the use of EHR systems for clinical research processes such that clinical research is optimized for clinics and hospitals, allowing new therapies to be available to patients in the shortest time at the lowest cost.
Achieving these objectives is of critical importance to the future of clinical research:
- The time and costs associated with clinical research by investigators, academia, government agencies, and industry have escalated. This has resulted in fewer new innovative medicines, more expensive and late delivery of therapies, failure to explore niche markets of high medical need, and the tendency to focus research resources on environments offering higher return on investment. Creating an environment for more efficient clinical research will reduce cost and time and increase productivity.
- Early clarification of the requirements for clinical research (both for clinical study conduct and research uses secondary to this) can facilitate their incorporation into EHR system development work ongoing today, and into plans for future expansion of these systems. Some of these secondary uses require little additional functionality over that already provided with commercial EHR systems and benefits could be realized right away. Some examples of secondary use include clinical study recruitment, drug safety & surveillance, retrospective analyses and prospective studies.
This project is the first step to build upon current work being done by HL7 and QRec, and to develop criteria at a global level that can facilitate the conduct of global clinical research.