Leading industry companies collaborate to demonstrate seamless exchange of data between clinical sites, research sponsors and regulators using the RFD standard
The Clinical Data Interchange Standards Consortium (CDISC), the leading standards development organization for clinical research, announced it will host a live Healthcare Link Demonstration at the 45th Annual Meeting of the Drug Information Association (DIA), being held June 21-25 at the San Diego Convention Center (Booth # 1915). The demonstration will showcase the Retrieve Form for Data-capture (RFD) integration profile, developed through the collaboration of key stakeholders and two standards groups, CDISC and Integrating the Healthcare Enterprise (IHE). The RFD standard facilitates data interoperability between clinical research and clinical care by integrating the processes and workflows of electronic data capture (EDC) and electronic health records (EHR) platforms.
“RFD is particularly effective in integration efforts because it enables EHR applications to directly request electronic case report forms from clinical research sponsors,” said Landen Bain, CDISC Liaison to Healthcare. “It also enables post-market reporting of drug safety adverse events, as well as applications in quality reporting and public health.”
The development of RFD has progressed rapidly, to the point where it’s being used in two real-world situations: Greenway Medical and Outcome Sciences are using RFD in a registry study and the ASTER study is using RFD to pilot a new model for capturing and reporting AEs. The Wall Street Journal printed an overview of the project in January 2009 (http://online.wsj.com/article/SB123085142405347511.html).
CDISC and Integrating the Healthcare Enterprise (IHE) have jointly supported the development of a process to electronically transcribe information from an EHR into an electronic case report form (eCRF) in an EDC system. In this process, routine patient information is documented in the EHR. When the user initiates RFD, the relevant data are sent to the EDC system where they are pre-populated into the eCRF which displays within the EHR interface. The eCRF is then completed, reviewed, verified for accuracy, and submitted to the EDC system. This same process can be automatically triggered by pre-defined drug safety triggers in the EHR that initiate the reporting of adverse drug events for drug safety reporting.
The RFD integration profile enables the integration of research and drug safety data capture into the healthcare workflow. Integrating patient care and clinical research minimizes manual data transcription, increases efficiency, and improves the quality of data received by research sponsors. This live demonstration will showcase how the implementation of RFD, coupled with CDISC standards, accelerates interoperability between EDC and EHR systems.
RFD demonstration participants include, Cerner Corporation, Greenway Medical Technologies, Nextrials, Inc., Outcome Sciences, Inc. and BioClinica, Inc, sponsored by Pfizer, Inc.
The DIA Annual Meeting is the biopharmaceutical industry’s largest, longest running, global, multidisciplinary event. Those interested in attending the annual meeting can visit http://www.diahome.org.
