The FDA recently published their announcement of a public meeting to discuss Solutions for Study Exchange Standards. The notice includes directions for how to register to attend the meeting (the email address, however is incorrect. Please refer to correct address at the end of this entry), and also a list of questions related to the use of standards, including asking for input on comparing HL7 transport standards to CDISC ODM.
This may be our best opportunity to convince FDA that an XML transport standard based on ODM for CDISC SDTM, SEND and ADaM content would be a better solution for submitting data than use of HL7 healthcare standards. We believe this forum will highlight the advantages of using the CDISC Operational Data Model (ODM), which is the basis for define.xml and a current component of the FDA study data standards. ODM has been successfully adopted by many researchers in both industry and academia, as well as technology vendors for transferring clinical data, metadata and terminologies with audit trail in a fully compliant manner.