Bay Area CDISC Implementation Network, 1/8/2007 Tips and Tricks for a Successful Define Document Guy Pawson, PhD Development eSubmissions Genentech, Inc

Bay Area CDISC Implementation Network, 1/8/2007 Defining “success”.. Your phone doesn’t ring during the review Define doc generation is: –Automated and seamless –Based on reliable metadata –Integrated into submission timeline

Bay Area CDISC Implementation Network, 1/8/2007 Get the priorities straight.. Dataset design comes first (Remember the original Bexaar BLA+RTF?) “We mainly used the CRFs and the SAS datasets for our review” (FDA Herceptin reviewer) Provide additional dataset explanation in a Data Tipsheet Complete and standardized metadata (Oh yes, get a define.xml utility)

Bay Area CDISC Implementation Network, 1/8/2007 The Data Tipsheet

Bay Area CDISC Implementation Network, 1/8/2007 Standard Metadata

Bay Area CDISC Implementation Network, 1/8/2007 Process Development for Define Doc Metadata Ownership – Statistical Programming Tipsheet Ownership –Stat Programming/Biostatistics CRT Publishing –eSubmissions, Medical Editing

Bay Area CDISC Implementation Network, 1/8/2007 Predicting the future.. Continuing disconnect between FDA public announcements and Agency realities: –Data warehouse –Ability of reviewers to use new data models/formats –Timing of move to eCTD standard (“Please send us a Roadmap file”)