Ancillary Data Management

Ancillary data are information provided by the investigator during or after the conduct of a clinical trial, not anticipated at the time of organization of the data base established to handle the study. This report describes the development of a separate data file that allowed the clinical program manager responsible for data analysis to capture this extra information accurately and efficiently from pilot studies critical to the development of a Phase III multi-center trial. The information was entered using an interactive screen. The data were organized into a file that was cross-checked and could easily be corrected using a separate program. Since this new data file was compatible with the original data base, a sharing of key elements such as eligibility, drug codes, and observation windows, allowed for rapid and efficient report generation and statistical analyses. These reports were helpful in designing larger more complex studies. A team effort of individuals involved in scientific data management and computer information analysis overcame the difficulties of handling ancillary data.