Clinical Research

Clinical Research Investigators in hospitals are often frustrated by the lack of interoperability between their EHR system and their clinical EDC system (EDC = electronic data capure system). This means that a lot of copy and paste work, or full reentering of the data in the EDC system is usually necessary. For example, if a patient has had 80 documented medications in the past, copying these (and their details) from the EHR into the EDC means a lot of work. The “SMART Clinical Researc app” allows investigators to automatically populate clinical research forms (following the CDISC CDASH content standard) for the “Demograpics” (DM) and “Prior and Concomitant Medications” (CM) domains for which the FDA requires to submit data in a standardized way from the EHR. Even after population, the researcher can still add additional data or correct data points that come from the EHR. After submitting the data to the EDC server, a PDF is generated by the system for the investigator's archive (this is an FDA requirement), and the data is displayed (for demo purposes) in the CDISC ODM format (www.cdisc.org/odm) which is the widely accepted format for exchange of clinical data.In the app, before the clinical forms are being made available, it is also checked whether the patient is eligible to take part in the study, based on age (the patient must be between 18 and 75 years), and based on the presence/absence of depressive order. The app uses servlet technology as well as well as a server-based implementation (Chiba) of XForms , a W3C standard for web forms. Furthermore, transformation into a PDF is done using a special XSLT stylesheet in combination with Apache FOP.  Further information is available at: www.xml4pharma.com/Smart_Challenge/index.html where also a movie explaining the application in further detail is available.