munging metadata

Last weekend was the 2nd HL7 FHIR Connectathon (Jan. 14 & 15) that included a Clinical Research Track and the 14th overall FHIR Connectathon. This event was hosted on the Riverwalk in San Antonio and featured over 200 attendees for a weekends worth of hacking. The primary purpose of the Connectathon events is to provide a forum for participants to develop and test software in an informal way. During the previous, inaugural Clinical Research Track < http://wiki.hl7.org/index.php?title=FHIR_Connectathon_13> only two of us participated.  By the end of the weekend we were able to use FHIR resources to demonstrate the pre-populate Medidata Rave-based demographics and concomitant medications CRFs. The Clinical Research Track at the 14th Connectathon generated quite a bit more participation interest with 8 attendees. Representatives from vendors, sponsors, and standards organizations participated. Beyond the pre-population of CRFs using EHR data retrieved using FHIR, sever...

As the CDISC XML Technologies team finalizes Define-XML v2.1 for internal review an old debate has re-surfaced: how much should the Define-XML specification focus on the regulatory submissions use case versus providing a more general specification that works for a broader set of use cases. As a standard that provides metadata to describe tabular datasets, Define-XML can be used to describe legacy datasets as well as datasets included for submissions. Define-XML has also been used as a specification for datasets. However, Define-XML became the most widely implemented ODM-XML based standard due its role as a required element of regulatory submissions. The importance of ensuring that Define-XML files included in a submission are complete and accurate makes a compelling case for adding rules that specifically target this use case at the risk of reducing its usefulness in other contexts. Having recently participated in the September HL7 FHIR connectathon in Baltimore, MD it strikes me ...