The SAS Clinical Standards
Toolkit provides the following support for the CDISC ADaM 2.1 standard:
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A metadata representation of the
CDISC ADaM standard in a set of SAS data sets.
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The ability to derive template
(zero-observation) data sets for the ADaM subject-level Analysis (ADSL)
data set, a representative Basic Data Structure (BDS) data set, and
an ADaM Adverse Event (ADAE) data set.
Note: Templates for additional
ADaM data structures will be provided in future releases after the
CDISC ADaM team approves them for use.
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Implementation of version 1.2 CDISC
ADaM validation checks as prepared by the CDISC ADaM team.
In addition, SAS has
provided validation checks for the ADAE and ADaM Time-to-Event (ADTTE)
domains. These validation checks are derived from individual implementation
guides provided by CDISC. For the ADAE domain, the release of the
implementation guide is Analysis Data Model (ADaM) Data
Structure for Adverse Event Analysis, Version 1.0. For
the ADTTE domain, the release of the implementation guide is ADaM
Basic Data Structure for Time-to-Event Analyses, Version 1.0.
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A sample reporting methodology
that combines the analysis results metadata with a sample set of tables,
listings, and figures (TLF) metadata to create example clinical study
reports.