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