Product EHR CR FP
Product Brief - HL7 EHR Clinical Research Functional Profile (EHR CR FP)
Electronic Health Record Systems - Clinical Research Functional Profile(EHR CR FP)
Application Functional Specifications
Normative, ANSI Standard
- ANSI/HL7 EHR CRFP, R1-2009
The EHR/CR Functional Profile is intended to provide high-level requirements necessary for using electronic health record data for regulated clinical research, and to further provide a roadmap towards an evolutionary process of integrating the environment that provides both patient care and data for clinical research. This functional profile is aimed at encouraging EHR vendors to incorporate functions into their products that are necessary to utilize the Electronic Health Records as a direct data source for clinical studies. It is intended to provide one overall view of the regulatory needs of clinical research with respect to electronic patient records.
Business Case (Intended Use, Customers)
- Clinical research institutions and system vendors seeking certification under CCHIT and EUROREC for certifying EHR systems.
The EHR Clinical Research profile will identify EHR functions such that:
- electronic healthcare systems, when used to collect source data for clinical research, can supply regulatory authorities with proof that data used to support claims made regarding the safety and efficacy of new medicines can be traced back to a 'reliable' data source.
- clinical research through the use of EHRs is optimized for clinics and hospitals, allowing new therapies to be available to patients in the shortest time at the lowest cost.
Implementations/ Case Studies (Actual Users)
- eClinical Forum
- Pharmaceutical Research and Manufacturers of America (PhRMA)
- Electronic Data Capture (EDC)/eSource Task Force
- For more information on the EHR-S FM and the HL7 Electronic Health Records Work Group, please visit: www.HL7.org/ehr.
- See more at http://www.hl7.org/implement/training.cfm
From HIMSS 2009
Relationship to/Dependencies on, other standards