News

Study Data Technical Conformance Guide and Data Standards Catalog

FDA published a statement about their evaluation of potential transition to acceptance Lab data results in SI units instead of currently preferable US Conventional units.

Sponsors are advised to talk with the agency to discuss this topic in early stages of product development to minimize potential risks during their regulatory submissions. 

See details on http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm372553.htm

New SDTM version is released. See http://www.cdisc.org/sdtm

Major updates are

1. A version of new SDTM IG is 3.2, rather than 3.1.4

2. New design of SDTM IG document as PDF portfolio 

3. New variables were added into SDTM model

4. 11 new domains in IG

5. New IG-AP descibes how to handle data about devices and persons who are not study subjects

The New Jersey CDISC User’s Group is resuming its activities.  As a starting point, we plan to focus on CDISC implementation challenges and experience, for both legacy data and new studies, as well as knowledge sharing across companies. 

FDA/Phuse “SDTM Validation Rules” project team had 2-days working session during annual Computational Science Symposium. http://www.phuse.eu/css

The CDISC XML Technologies team has released the Define-XML 2.0 specification. http://www.cdisc.org/define-xml

Key changes to the model include:

• Support for CDISC Controlled Terminology 
• Flexible definition of Value Level metadata 
• Enhanced documentation of data origin or source 
• Improved handling of comments.

Data Standards & Terminology Standards for Info Submitted to CDRH1.usa.gov/168pw9m #fda #medicaldevice

— FDA/CDRH Industry (@FDAcdrhIndustry) March 6, 2013

http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm

Dear all,

 Check out the paper and programs of the "Controlling OpenCDISC validator using R" paper by Martin Gregory that was published in Pharmaceutical Programming, vol. 5, no. 1&2,  Dec. 2012.

paper: http://www.phusewiki.org/docs/2012/PAPERS/TS/TS05.pdf

programs: http://www.phusewiki.org/wiki/index.php?title=Controlling_OpenCDISC_Validator_using_R

CDISC team updated SDTM/ADaM Pilot Project package. 

There are many iinteresting updates in define.xml files.