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

June 4, 2024

We are excited to announce the release of Pinnacle 21 Community 4.1.0. This release adds support for Dataset-JSON for both validation and data conversion.  Release notes are below (and can also be found in the Help menu within P21C).

Pinnacle 21 Community version 4.1.0 (released 31-May-2024)

- Fixed handling for extensions of Standards specifically for Define-XML 2.1 (bug fix)
- Fixed an issue where Define-CT files were not being pushed when published (bug fix)

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March 21, 2023

PMDA engine 1511.6 (aka "PMDA rules version 1.0") is being phased out at PMDA. This legacy engine was valid for initial submission dates of 2016-10-01 to 2021-03-31 and was maintained as backup only for past submissions already under PMDA review. End of support is planned for 2023-03-27. After this date, PMDA 1511.6 will no longer be available in the Engine drop down.

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April 24, 2022

Hi, this is MinJi.

Any news on when SDTM-IG 3.3 PMDA engine will be supported?


Best regards,


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December 20, 2021

See details on

See details in "Data Standards Catalog and CDISC Data Validation" section on PMDA New Drug Review with Electronic Data webpage and Pinnacle 21 Blog.

Our educational webinar is coming soon.




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May 24, 2021

We are excited to announce the release of Pinnacle 21 Community 3.1.2. This minor patch release only changes the version of JRE that we use.

Pinnacle 21 Community version 3.1.2 (released 11-Jun-2021)

- Updated the version of bundled Java Runtime Environment (JRE) to OpenJDK 1.8.0_292 (enhancement)

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November 2, 2020

Available now in FDA (1907.2) engine 

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December 4, 2019


Can we download the validation rules from Pinnacle 21 website? or Is there excel version of validation rules?



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October 1, 2019

Dear Team,
Could you please let us know when will the Pinnacle21 Community Version compatible with new PMDA v2 rule be released?
(v2 rule means that it's Enterprise 4.0.2 and Engine Version 1810.3)

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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


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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