SP05
The 800 Pound Gorilla: Taking on the Challenge of Globally Standardizing AE and Medication Reporting
Deborah Harper, Pfizer Global Research and Development
Jennifer Tjernagel, Pfizer Global Research and Development

When Pfizer merged with Warner-Lambert/Parke-Davis in 2000, work began to harmonize various processes across all sites. One of these efforts sought to standardize the collection and reporting of clinical data. The principle guiding the process was to first determine what needed to be reported, and work backwards toward data collection. The initial step was to agree on a set of standard summary and listing tables for each data type defined in the Clinical Data Interchange Standards Consortium (CDISC). Thi s presentation will discuss how we started, the process used, decision making, resulting tables, and the SAS algorithms necessary to implement the standards for adverse events (AEs) and medications. Issues we addressed include common coding dictionaries , levels of reporting, definition of treatment, imputing dates, and treatment emergent signs and symptoms (TESS) definition. Our presentation will focus on tables, and algorithms which aid in the development of SAS code.