Is there any update on the release of new version of pinnacle21 community software?
Community version of the Validator is based on officially published rules from CDISC, FDA and PMDA.
Enterprise versions of the Validator since version 3.4.1 include a draft implementation of new unfinalized conformance rules from CDISC team.
There are also several major changes in general approach for validation of ADaM data. New validation for ADaM data is still considered as a draft implementation until a new official release of ADaM Conformance Rules from CDISC, as well as review and approval from PMDA and FDA teams.
Support for ADaMIG 1.1 validation will be available in the next release of Community scheduled for the end of February.
Could you let us know when will the P21 Community Version for ADaM IGv1.1 be released?
New Community 3.0.0 release date is planned for end of April.
Is the new release still scheduled for the end of April?
within next 2 weeks
Will this new Pinnacle Community version include the updates from SDTMIG 3.3? Please confirm.
No, validation rules for SDTM IG 3.3 in Community version will be available after their official release by CDISC team.
Thanks for the prompt response! I thought it was released officially already. What other changes can we expect in version 3.0?
SDTM IG 3.3 was released recently as standard documentation. However, official validation rules from CDISC team are still not available. We've implemented a draft validation for SDTM IG 3.3 which is available only in Enterprise version as temporal custom P21 config, but cannot be published in Community.
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When will Pinnacle21 support CDISC ADaMIGv1.1?
Is there a timeline for when Pinnacle21 begins to support CDISC ADaMIGv1.1?