|
About the News category
|
|
0
|
4
|
March 24, 2025
|
|
P21-client-1.0.8 - New FDA 2405.2 Engine
|
|
8
|
35
|
April 16, 2025
|
|
PMDA 2411.0 engine is available in Community now
|
|
0
|
72
|
April 1, 2025
|
|
PMDA published validation rules Version 6.0
|
|
2
|
37
|
March 14, 2025
|
|
2405.2 validation engine
|
|
1
|
27
|
February 20, 2025
|
|
Community 4.1.0 Released
|
|
0
|
9
|
June 4, 2024
|
|
PMDA 1511.6 to be decommissioned on March 27th, 2023
|
|
0
|
3
|
March 21, 2023
|
|
Minor updates on Reviewer Guides
|
|
3
|
4
|
January 3, 2023
|
|
Any news on when SDTM-IG 3.3 PMDA engine will be supported?
|
|
2
|
4
|
May 13, 2022
|
|
Community 3.1.2 Released
|
|
2
|
7
|
March 29, 2022
|
|
New PMDA rules v3.0 are available as PMDA 2010.2 engine
|
|
0
|
2
|
December 20, 2021
|
|
privacy agreement
|
|
2
|
3
|
December 3, 2020
|
|
Support for validation of SDTM-IG 3.3
|
|
2
|
4
|
November 3, 2020
|
|
validation rules download
|
|
1
|
3
|
December 5, 2019
|
|
Is there a timeline for when Pinnacle21 Community begins to support new PMDA validation rule?
|
|
5
|
11
|
November 21, 2019
|
|
CDISC Terminology for Validation
|
|
10
|
15
|
October 10, 2019
|
|
SDTM CT TERMINOLOGY UPDATE IN PINNCALE 3.0 TOOL
|
|
8
|
11
|
June 26, 2019
|
|
Release of new Pinnacle21 community version
|
|
10
|
16
|
May 3, 2019
|
|
FDA Validator Rules 1.3 released
|
|
0
|
2
|
November 13, 2018
|
|
New FDA business rules for SDTM and SEND studies
|
|
5
|
9
|
May 25, 2018
|
|
Version 1.0 of the Analysis Results Metadata Specification for Define-XML v2 is now available
|
|
0
|
2
|
February 2, 2015
|
|
CDISC Questionnaire and Functional Test (QS-FT) Terminology has been deprecated
|
|
0
|
2
|
January 29, 2015
|
|
Portal with CRFs in CDISC ODM format
|
|
1
|
3
|
January 6, 2015
|
|
New FDA Guidances on Standard Data for Electronic Submissions
|
|
0
|
3
|
February 7, 2014
|
|
FDA CDER/CBER Position on Use of SI Units for Lab Tests
|
|
0
|
2
|
January 16, 2014
|
|
SDTM v1.4, SDTMIG v3.2, and SDTMIG-AP v1.0
|
|
2
|
5
|
January 7, 2014
|
|
Comment period has begun for SDTMIG v3.1.4 Draft Supplements - Batch 1
|
|
1
|
4
|
August 22, 2013
|
|
The New Jersey CDISC User’s Group is resuming its activities
|
|
0
|
2
|
May 1, 2013
|
|
Recent FDA/PhUSE CSS event and OpenCDISC plans for quick update
|
|
0
|
2
|
March 21, 2013
|
|
Define-XML 2.0 now available for use
|
|
0
|
2
|
March 16, 2013
|