CDISC - FDA Pilot Data Sets The following analysis datasets are based upon the first CDISC Pilot, a collobarative pilot project with FDA and Industry to assess how CDISC-adherent datasets and associated metadata met the needs and expectations of FDA review staff. These data sets are available courtesy of CDISC. Refer to CDISC for the CDISC SDTM/ADaM Pilot Project Report.
THESE ARE ABBREVIATED FILES: