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SDTM: Frequently Received Answers to Questions
This forum is hosted by CDISC with content provided by the PhRMA Study Data Tabulation Model Best Review Practices Group.
DISCLAIMER: Information posted on this website is volunteered by those submitting data via the SDTM standard to the FDA. The information provided on this site is for informational purposes only. It does not represent FDA policy or CDISC endorsement. Each sponsor is encouraged to have appropriate communications with the FDA.
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 Implementing SDTM and ADaM in the C...
> 2008-04-30 10:37 AM by jpevans |
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General Issues
Issues spanning topics.
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RE: what domain to use?
> 2008-08-29 4:29 PM by Anthony Chow |
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SDTM/ADaM Pilot Project Report & Submission Pkg
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Fee for test SDTM submission to FDA...
> 2008-09-03 4:19 AM by CSFrancis |
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SDTM Implementation Guide V3.1.2 Draft for Comment
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RE: Specified Treatments - CM or EX
> 2008-08-27 6:56 AM by Tore Haglund |
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SDTM V1.2 Draft for Comment
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Re: 8-character limitation
> 2007-12-18 7:28 AM by lltmehta81 |
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Terminology
Review comments, questions, and suggestions related to the CDISC Terminology effort.
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Re: VSTESTCD for Waist Circumferenc...
> 2008-07-25 3:33 AM by XML4Pharma |
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ODM V1.3 Final
Comments, questions, ideas, issues and suggestions about the Operational Data Model Version 1.3 Final.
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Re: Correct Schema URI
> 2008-05-30 12:59 PM by XML4Pharma |
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ADaM Version 2.0 Final
Comments, questions, ideas, issues and suggestions about the Analysis Data Model Version 2.0 Final.
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blankcrf.pdf for Analysis Metadata
> 2008-07-24 2:57 PM by saravanan |
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SDTMIG V3.1.1 Final
Comments, questions, ideas, issues and suggestions about the Study Data Tabulation Model Implementation Guide Version 3.1.1 Final
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Re: BRTHDTC - derived Day and Month
> 2008-09-07 5:38 AM by XML4Pharma |
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SDTM V1.1 Final
Comments, questions, ideas, issues and suggestions about the Study Data Tabulation Model Version 1.1 Final Version
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Re: Lab domain standard codelists.
> 2007-09-20 9:22 AM by xzhou |
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Case Report Tabulation (CRT-DDS or define.xml)
Comments, questions, ideas, issues and suggestions about the CRT-DDS V1.0 (define.xml).
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Re: DataType
> 2008-07-30 5:47 PM by Lex Jansen |
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Lab Model Comments - Micro, Schema, ECG & V1.0.1
Comments, issues and great thoughts prompted by Lab Model Comments - Micro Draft, Schema Draft, ECG Draft and V1.0.1.
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Lab question
> 2007-03-08 12:46 PM by ocuser |
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Laboratory Data Interchange Standard Version 1.0
Comments on Version 1.0 of the Laboratory Data Interchange Standard Version
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Conversions and Units
> 2007-02-13 9:14 PM by Phil Pichotta |
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Glossary Group
Matters particularly applicable to the Glossary Group.
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V6.0 Acronyms
> 2008-02-04 9:07 PM by marthur |
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Implementing SDTM & ADaM in the Clinical Data Flow
The SDTM and Analysis Datasets Implementation Expert Team, a subgroup of PhRMA’s Biostatistics and Data Management Technical Group, has written a guide discussing how companies can implement SDTM and ADaM in their clinical data flow processes. The guide, called “Implementing SDTM and ADaM in the Clinical Data Flow,” is included in this forum. The purpose of this forum is to provide a place to post feedback on the guide.
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Submissions Data Domain Models V3.1 Final Version
Comments, questions, ideas, issues and suggestions about the the Submissions Data Domain Models V3.1 Final Version.
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CMDECOD
> 2007-01-24 7:27 PM by Jennifer Lin |
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Protocol Representation Comments
Comments, questions, ideas, issues and suggestions about the Protocol Representation spreadsheet and supporting documentation.
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Trial design model part 2
> 2007-01-24 8:49 AM by sarah youssef |
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Operational Data Model Version 1.2 & V1.2.1
Comments, issues and great thoughts prompted by CDISC Operational Data Model Version 1.2
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ExternalCodeList vs ReferenceData
> 2007-02-01 6:35 PM by yashan |
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SDTM Controlled Terminology Package 1 Draft
Comments, questions, ideas, issues and suggestions about the SDTM Controlled Terminology Package 1.
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Define.xml and controlled terminolo...
> 2005-08-23 7:51 AM by Carolyn Wilson |
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Study Data Tabulation Model (SDTM) Version 1.1
Comments, questions, ideas, issues and suggestions about the Study Data Tabulation Model Version 1.1 Draft
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Re: light off and CDISC
> 2006-07-04 5:14 AM by Steve Barlow |
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Statistical Analysis Dataset Model: General
Comments, questions, ideas, issues and suggestions about the Statistical Analysis Dataset Model: General Considerations Document Version 1.0.
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Re: Analysis Datasets to mirror CRT...
> 2005-01-25 7:11 AM by Jack Shostak |
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FDA Public Meeting SDTM Discussion Topics
Suggestions for SDTM discussion topics at the FDA Public Meeting on 1-Feb-2005
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Re: SuppQual structure
> 2005-05-03 1:24 PM by Julie Evans |
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Submissions Data Standards V3.0 Review Comments
Comments, issues and great thoughts prompted by the CDISC SDS model Version 3.0.
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Re: submission example
> 2005-06-09 1:05 PM by Julie Evans |
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Submission Data Standards V2.0 Group Comments
Comments, issues and great thoughts prompted by the CDISC SDS models, Version 2.0 and earlier.
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RE: Why does CDISC use 8 char var n...
> 2007-03-11 9:57 AM by ewqweq |
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Submissions Data Standards V3.1 Review Comments
Comments, questions, ideas, issues and suggestions about the the SDS V3.1 Review Version.
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Re: Intermediate MedDRA levels in S...
> 2006-07-06 1:16 PM by Sarvesh Singh |
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HL7 Ballot Comments for Define.XML & Annotated ECG
Comments, issues and great thoughts prompted by the HL7 Ballot to Define.XML & Annotated ECG
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Re: Assignment to a domain
> 2004-03-31 10:33 AM by Julie Evans |
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SDS V3 Topics for Discussion at FDA Public Meeting
SDS V3 Topics for Discussion at FDA Public Meeting
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Re: What does HL7 approve for SDS?
> 2003-12-04 4:36 PM by Julie Evans |
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ODM 1.0 DTD/ Data Interchange and Archival Stands
Matters particularly applicable to the Data Interchange and Archival Standards Group.
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Re: Element declaration in ODM1-2-1...
> 2005-04-07 2:44 AM by Jozef Aerts |
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Analysis Dataset Model Group (ADaM)
Analysis Dataset Model Group (ADaM)
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Re: Contens of AE / Medication data...
> 2005-07-29 8:10 AM by Jack Shostak |
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CDISC Connectathons
For the July 2001 CDISC Connectathon
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Presentation of CDISC-ODM as PDF
> 2002-03-21 11:55 AM by XML4Pharma |
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FDA ECG Submission Standards
Comments on FDA-proposed ECG interchange standard as detailed in Digital ECG Data Submissions page on the FDA web site.
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recent cenusus
> 2005-11-30 3:25 PM by tobin |
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Operational Data Model Version 1.1 DTD Comments
Comments, Issues and great thoughts stimulated by the ODM Version 1.1 DTD released for comment in September 2001.
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Re: Add scheduling information to t...
> 2003-05-02 8:29 AM by Sally Cassells |
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SEND V2.0 (Standard for Exchange of Non-clin Data)
Comments, questions, ideas, issues and suggestions about the SEND Version 2.0.
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Re: PK data
> 2005-07-26 5:30 PM by Julie Evans |
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SDTM: Frequently Received Answers to Questions
