RL28 Talking Standards: From ADaM to WebSDM
*Stephen Wilson, U.S. Food and Drug Administration 


The Agency continues to charge ahead along the “Critical Path” with CDISC, HL7, vendors, and industry in promoting and establishing standards for drug development – eCTDs, CRFs, observed data from clinical trials, analysis files, metadata, CRFs, protocols, operational data, animal data, adverse events, health records, electronic source, BRIDG, RIM, etc – everything is fair game. Who are the players? What are the games? What do we know? What do we need to know? How can we even know what we don’t know? How does this impact you? This will be a chance for statisticians to gather for a friendly, informal chat – a review perspective on the “goings-on” surrounding standards.