Submissions Data Domain Models
Version 3.0
A revised
Version 3.0 (V3) of the CDISC Submission Data
Domain Models has been released by the CDISC
Submission Data Standards (SDS) Group. This
final version incorporates changes to the March
21, 2003 draft version as a result of responses
received from CDISC and HL7 participants during
the comment period. Version 3.0 will be undergoing
testing for an FDA pilot project through September
2003. Comments on this version will be considered
for the next release of the models, which is
planned for late in 2003, and may be submitted
through the CDISC Discussion Forum at http://www.cdisc.org/discussions/discussions.html.
Version 3 is also available as an informative
document from HL7 http://www.hl7.org.
A List
of Comment Period Changes from the March
21, 2003 review draft and the June 6, 2003 final
versionhas been prepared to assist readers who
are already familiar with the earlier document.
The V3
Review Comments and Responses contains detailed
comments and responses from
the review of the Comment Version of the SDS
V3 specification. The comments originated
from the CDISC public review and the HL7 balloting
process. The responses were developed
by the SDS group.
The V3
Submission Data Domain Models Supplement
contains additional information that is being
evaluated by the SDS team during the FDA pilot
period. Portions of this material is expected
to be included in the next release of the Data
Domain Models.
A Version 2 to Version 3 Change
Log is being prepared to assist V2 users who
are planning to convert to V3. This details
each major change to the models between versions,
and can be used to assist in the process of
mapping or conversion of data. This document
will be posted soon.
The CDISC SDS Codelist Task
Force is preparing direction on the use of Controlled
Terminology with the CDISC V3 domain models.
The scope of the document will be expanded periodically
with terminology for additional variables.
Please visit this page often, as additional
information on Version 3 will be published incrementally
throughout 2003.
Submissions Data Domain Models
Version 3.0
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