Difference between revisions of "SDTM in RDF"
From PHUSE Wiki
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Revision as of 14:20, 30 May 2013
SDTM Standards in RDF
|Document Description||Document Version||URL||Represent in RDF?|
|SDTM||v1.2, IG v3.1.2||Zip Archive||Done|
|SDTM||v1.2, IG v3.1.2, Amendment 1||TBD|
|SDTM||v1.3, IG v3.1.3||Zip Archive,
Metadata tables in Members Only
|Medical Device Supplement||v1.0||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)||TBD|
|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||TBD|
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.