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Reference
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Web Address **
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Description
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CDISC CDASH 1.1
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Provides access to the Clinical
Data Acquisition Standards Harmonization (CDASH) standard
(version 1.1) and the Clinical Data Acquisition Standards
Harmonization (CDASH) User Guide (version 1-1.1).
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CDISC SDTM 3.1.2
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Provides access to the Study
Data Tabulation Model (Version 1.2) and the Study
Data Tabulation Model Implementation Guide: Human Clinical Trials
(Version 3.1.2).
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CDISC SDTM 3.1.3
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Provides access to the Study
Data Tabulation Model (Version 1.3) and the Study
Data Tabulation Model Implementation Guide: Human Clinical Trials
(Version 3.1.3).
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CDISC SDTM 3.2
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Provides access to the Study
Data Tabulation Model Version 1.4, the Study
Data Tabulation Model Implementation Guide: Human Clinical Trials
Version 3.2, the Study Data Tabulation Model
Implementation Guide: Associated Persons Version 1.0,
and the Study Data Tabulation Model Implementation Guide
for Medical Devices (SDTMIG-MD) Version 1.0.
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CDISC SEND 3.0
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Provides access to the Standard
for Exchange of Nonclinical Data Implementation Guide: Nonclinical
Studies, Version 3.0.
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CDISC CRT-DDS 1.0
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Provides access to the Case
Report Tabulation Data Definition Specification (CRT-DDS, also called
define.xml) Final Version 1.0.
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CDISC Define-XML 2.0
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Provides access to the
Define-XML 2.0 standard.
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CDISC Dataset-XML 1.0
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Provides access to the
Dataset-XML 1.0 standard.
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CDISC ODM 1.3.0
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Provides access to ODM
Version 1.3.0 files and documentation.
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CDISC ODM 1.3.1
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Provides access to ODM
Version 1.3.1 files and documentation.
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NCI CDISC Controlled
Terminology
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Provides access to CDISC
Controlled Terminology.
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CDISC ADaM 2.1
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Provides access to the Analysis
Data Model, Version 2.1 and the ADaM Implementation
Guide, Version 1.0.
Note: Registration might be required.
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CDISC ADaM 2.1 Validation
Checks
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Provides access to the
CDISC ADaM Validation Checks
Note: Access to the CDISC members-only
site might be required.
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CDISC Analysis Results
Metadata 1.0 for Define-XML 2.0
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Provides access to the
Analysis Results Metadata 1.0 extension for Define-XML 2.0.
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Data Structure for Adverse
Event Analysis Version 1.0
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Provides access to the
Analysis Data Model (ADaM) Data Structure for Adverse Event Analysis
Version 1.0.
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Data Structure for Time-to-Event
Analyses Version 1.0
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Provides access to the
ADaM Basic Data Structure for Time-to-Event Analyses Version 1.0.
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OpenCDISC Validation
Rules
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Provides access to the
OpenCDISC CDISC Validation Rules Repository.
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Janus Operational Pilot
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Provides information
about operational pilots to date, including error checks.
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ISO 8601:2004 Data Elements
and Interchange Formats—Information Interchange—Representation
of Dates and Times
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Provides information
about the ISO 8601 standard.
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FDA Study Data Standards
Resources
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Provides access to a
variety of resources in support of submission of clinical study data
to the FDA.
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Advanced Review with
Electronic Data Promotion Group (PMDA)
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Provides information
about the PMDA's new approach to electronic submissions of study
data.
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SAS Technical Support
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Online form: http://support.sas.com/ctx/supportform/createForm
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Provides access to a
form on which any problems experienced with the product and technical
questions should be documented. Or, you can call (in North America)
919-677-8008.
Otherwise, contact your
local SAS office.
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SAS Knowledge Base for
the SAS Clinical Standards Toolkit
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Provides current information,
documentation, technical papers, and presentations about the SAS Clinical
Standards Toolkit.
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SAS Clinical Standards
Toolkit Documentation
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Provides a link to this
document and other documents.
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SAS Clinical Standard
Toolkit: Papers
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Provides links to papers
written about the SAS Clinical Standards Toolkit.
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SAS Clinical Standards
Toolkit Samples and SAS Notes
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Provides a way to search
SAS installation problems, usage problems, samples, and SAS Notes
that are associated with the SAS Clinical Standards Toolkit.
(Type Clinical
Standards Toolkit in the search field.)
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SAS in Health Care and
Pharma Community
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Provides access to a
primary public discussion forum for the SAS Clinical Standards Toolkit.
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SAS Training
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Currently, SAS is pursuing
the development of SAS Clinical Standards Toolkit training classes.
Some information about the SAS Clinical Standards Toolkit is provided
in the SAS Clinical Data Integration: Essentials training course.
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External Vendor Tutorials
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Offers product tutorials
from vendors, often as a part of an industry-related user conference.
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