November 18, 2009 at 9:17 AM by cdisc

Fifteen attendees and presenters spend Friday the 13th teaching, learning, and sharing concepts around CDISC’s healthcare link project. This is the second time that CDISC has presented a training session on healthcare link, the first being the Japan Interchange last July.

The ¾ day session begins with an explanation of how the recently released HITSP Interoperability Specification 158 ties together components from HL7, IHE, and CDISC to address the transfer of a core data set from EHRs to research systems. Jason Colquitt of Greenway Medical, who chairs the IHE committee that deals with research, followed with a description of how IHE develops profiles such as Retrieve Form for Data-capture (RFD). Dan Levy of Outcome Sciences takes the session deeper and focuses in on RFD, the cornerstone of CDISC’s healthcare link activities. We delve into the actors and transaction that comprise RFD, the Form Filler, Form Manager, Form Receiver and Form Archiver. These actors allow EHRs and EDC systems to present electronic case report forms to EHR users, partially pre-populated. The group offers good feedback to the presenters and useful discussion follows, a gratifying indicator that ideas and concepts are being conveyed, ingested, and clarified. Finally Jake Mundt, also of Outcome Sciences, leads a live laboratory session that allows the participants to exercise RFD transaction from their laptops. This hands-on exercise brings the capabilities home, but not without difficulty, as participants download forms players, surface forms, populate forms with data, submit and archive data, and pre-populate data from standard documents.

Our participants are a diverse group with three from Japan, three Europeans, and three from the US. RFD is very active in Japan, with implementions at Hamamatsu University and Tokyo University. And CDISC Japan is working to organize a drug safety application of RFD which will route adverse events to the Japanese regulatory agency. Pierre-Yves Lastic from Sanofi attends the session and plans to present similar material in Europe. Rich Furr of SAFE Biopharma brings his interest in digital signature and authentication, functionality that will enhance the core healthcare link practice. So interest is expanding, implementations come along, but we still lack a formal phase three study that uses RFD as a means of data capture. Any takers?