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CDISC Data Set Page

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:

Description SAS Transport CSV Notes
Adverse Event Analysis Dataset (ADAE)
Description ADAE.xpt ADAE.csv -
Chemistry Lab Analysis Dataset (ADLBC)
Description ADLBC.xpt ADLBC.csv -

COMPLETE SETS OF ADAE AND ADLBC FILES CAN BE FOUND HERE
CDISC - Zip Files - v08092011

  • Please acknowledge CDISC when using these files.
Topic revision: r12 - 13 Sep 2013 - 12:20:37 - MaryBanach
 

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