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Standards Documents

Document Description Document Version URL Represent in RDF? Assignees
SDTM v1.2, IG v3.1.2 Zip Archive Done Ron and Scott to explore modeling Domain Assumptions
SDTM v1.2, IG v3.1.2, Amendment 1 PDF TBD
SDTM v1.3, IG v3.1.3 Zip Archive,
Metadata tables in Members Only
Y Dan: IG v3.1.3
Scott: v1.3
Medical Device Supplement v1.0 PDF TBD
Polycystic Kidney Disease User Guide v1.0 (Provisional) Zip Archive TBD
Parkinson's Disease User Guide v1.0 (Provisional) Zip Archive TBD
Virology User Guide v1.0 (Provisional) PDF TBD Steve
Pain User Guide v1.0 (Provisional) Zip Archive TBD
Tuberculosis User Guide v1.0 (Provisional) Zip Archive TBD
Alzheimer's Disease/Mild Cognitive Impairment User Guide v1.0 PDF TBD
SEND Implementation Guide, v3.0 IG v3.0 Y Scott

Ontology Import Files

Notes on Documents

  • We agreed that as a first stab we'd stick to the non-provisional standards.
  • SDTM 3.1.2 Amendment 1 is more of the same and should be able to be easily added to the model. AE gets 10 new allowable variables, DM gets 8 new allowable variables. Content is in PDF, but in tabular format in the PDF and DanBoisvert could turn it into .xls if we need to.
  • Alzheimer's Disease/Mild Cognitive Impairment - This document is more of an explanation of how to apply the SDTM 3.1.2 to Alzheimer trials. No new variables are identified. There is something about a 'Non Subject' domain that is under consideration by the SDS team (sounds interesting...collecting data about family history but the data isn't about the patient themselves).
Page 9 - See Non-Subject Data Supplement v1.0 to SDTMIG for NS domain tables -This domain is under review with the CDISC SDS team, following the CDISC domain development process. This section will be updated upon release of the approved domain.The SDTMIG:NS is intended to guide the organization, structure, and format of standard data for persons who are not the subject in a clinical trial, but about whom data has been collected, when that data will be submitted to a regulatory authority such as the US Food and Drug Administration (FDA). This guide describes the implementation of any data tabulations collected about persons of interest in a clinical trial who are not the subject in the trial. These non-subject persons may or may not have a relationship to a clinical trial subject.

Meeting Materials

Date Presentations Meeting Minutes Meeting Recording
20 May 2013 Project Kickoff NA NA
Week of 10 Jun 2013 N/A N/A Meeting Recording
09 Jul 2013 N/A * Discussed representation of SDTM IG v3.1.2 Domain Level assumptions in RDF reviewed by Ron
* Frederik to add an example to SDTM v.3.1.2 ontology and others to review
* Dan working through representation of SDTM v1.3/IG v3.1.3
* Scott working through SEND v3.0

Other Documents