FDA
Acknowledges CDISC Models - A CDER
Patient Profile pilot project was announced
via the Federal Register on 5 December
2001. This announcement acknowledges the
planned use of the CDISC Submission Domain
Models for a standard representation of
CRT datasets and metadata in conjunction
with a pilot to test a new standard patient
profile application. Pilot participants
will be chosen "based upon their
experience with providing CRTs and their
familiarity with the standards recommended
by CDISC".