What is the relationship between CDISC and FDA?
FDA’s official position is that of “observer” when involved in CDISC activities. FDA representatives participate as liaisons on CDISC teams, present at CDISC conferences, present at other industry conference on the need for (CDISC) standards. FDA presentations have provided public endorsement of CDISC activities, including encouragement to those developing eSubmissions to use SDTM and ADaM. CDISC is specifically named in the Critical Path Opportunities List for developing standards to streamline clinical trials. CDISC was awarded a contract from FDA to teaching reviewers and statisticians about CDISC; through this relationship, there are four different CDISC courses, including SDTM and ADaM, which have been taught now to over 300 reviewers. Representatives of the Department of Scientific Investigation (DSI) requested the work that generated the eSource Data Interchange (eSDI) document. FDA is leading an effort to develop HL7 transport standards that would carry CDISC content, including
