CDISC Updates

 

Newly Published Standards

- CFAST Therapeutic Area Standards User Guide for Cardiovascular Studies (CV Endpoints and ACS) v1 has been posted for provisional use

- SDTM v1.4 / SDTM IG v3.2 electronic metadata are available as an Excel spreadsheet or define.xml form generated from CDISC SHARE.  This is available in the CDISC Member's Only area

- CFAST Therapeutic Area Standards User Guide for Influenza v1 has been posted for provisional use

- CFAST TAUG for QT Studies v1 has been posted for provisional use

- Controlled Terminology Package 20 has been posted for use

- CFASt TAUG for Schizophrenia is scheduled to be posted for public comment in February

- Draft ADaM Data Structure for Integration (ADSL) is scheduled to be posted for public comment in February

- The CDISC Standards in RDF Reference Guide, prepared by the PhUSE CS Semantic Technology WorkingGroup is open for public comment until 20th February

- ADaM Analysis Results Metadata Specification for define.xml V2.0 is now available for use

- The first release of electronic metadata for ADaM v2.1 from SHARE is now available for download

- CDASH v1.1 to SDTMIG v3.1.2 mapping metadata from SHAE is now available for download.

 

Standards Available for Public Review

- CFAST Therapeutic Area Standards User Guide for Hep-C v1.0

- SDTM Pharmacogenomics/Genentics (PGx) v1.0

- SDTM v3.3 Batch 2 and SEND v3.1 (coming soon)

- SDTM IG: Pharmacogenomics Genetics v1 (02-Dec-2014)

- SEND IG v3.1 (04-DEC-2014)

- SDTM IG v3.3 Batch 2 (10-DEC-2014)

- Schizophrenia Therapeutic Area Guide is now open

- The BRIDG R4 reference model, which has been updated to include the NCI Life Sciences DAM and support for SDTMIG v3.1.13 is now posted for CDISC public comment. Comments are due by 11th May. 

- Terminology Package 21 with more than 850 new terms for SDTM, SEND and COAs was released on 27th        March. 

- The ADaM Structure for Occurrence Data (OCCDS) which extends the ADaM ADAE Data Structure for Adverse Events Analysis to other occurrence data such as ConMeds, is nearing final publication.

- The provisional CFAST TAUG for Chronic Hepatitis C was released on 8th May.

- ADaM v1.3 validation checks were released on 16th May.

- Cardiovascular and diabetes TAUG metadata have been posted to eSHARE.

CDISC will be releasing a significant number of work packages in June including ADaM Structure for Occurrence Data, SDTM PGx package and amended draft of SEND v3.1 for public comment.

Please visit cdisc.org for a complete list of CDISC updates and activities.

 

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