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Pilot Project Report

The project report describes the pilot submission package and the processes followed, including the decisions made to produce the package, and lessons learned from the experiences of the pilot and from feedback from the regulatory review team.  Each step of the pilot process and work completed are easily followed in the report beginning with the de-identification of the pilot legacy data, application of CDISC Standards (including SDTM, ADaM, and CRTDDS), and resulting in the creation of a CDISC-compliant electronic clinical study report submission.

CDISC SDTM/ADaM Pilot Project Report