News

Description

Latest news about data validation, CDISC standards, and regulatory compliance

June 24, 2019
I want to add SDTM CT terminology of "2019-03-29". But, I can't add it. When it will be updated in pinnacle tool 3.0 ?
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May 13, 2019

Hi,

in the new privacy agreements there is the sentence

" ... As further described in Section 2, below, in the course of providing and supporting the Services, Pinnacle 21 may process some limited amounts of information regarding participants in studies, including but not limited to participants in clinical trials (the “Study Participants”) ..."

As we as a CRO are not the owners of the data we will not be able to grant the use of these data to others.

Does that mean that we cannot use the Pinncale 21 anymore?

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November 13, 2018

See details on our Blog 

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September 7, 2018

Hi,

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

 

Thanks,

Ravish

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March 17, 2017

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

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January 6, 2017

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

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

 

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January 29, 2015

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 

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January 29, 2015

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

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December 23, 2014

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

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