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.
Hi, this is MinJi.
Any news on when SDTM-IG 3.3 PMDA engine will be supported?
See details on
Our educational webinar is coming soon.
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.
- Updated the version of bundled Java Runtime Environment (JRE) to OpenJDK 1.8.0_292 (enhancement)
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)
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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