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Hi,

Is there any update on the release of new version of pinnacle21 community software?

Thanks,

Ravish

These rules will ensure that data is compliant, useful, and supports meaningful review and analysis. They also supplement the recently published CDISC conformance rules. How these rules will impact P21 users will be covered in our webinar - coming soon!

https://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm2005545.htm

All versions of CDISC Terminology for validation can be downloaded from here:

https://www.pinnacle21.net/downloads/cdisc-terminology

http://www.cdisc.org/adam#armv1

ReadMe.txt:

"December 19, 2014

With this December 19th release of the CDISC terminologies, the standalone Questionnaire and Functional Test (QS-FT) 

Terminology has been deprecated and its content subsumed into the Clinical Outcome Assessments (COA) Terminology.  

For the latest QS-FT content and codelists please access the COA Terminology download location, 

http://evs.nci.nih.gov/ftp1/CDISC/COA/ using your web browser, or access 

PhUSE recently posted new versions of Reviewer Guides documentation with minor updates. See details:

A public portal for CRFs in CDISC ODM format is available at

http://medical-data-models.org

Currently it contains >5.000 forms.

The system is provided and maintained by the Institute of Medical Informatics, University of Münster, Germany.

Please send feedback to dugas@uni-muenster.de

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