General Discussion

Hi all

With regards to variable COUNTRY, now that FDA has issued https://www.access.fda.gov/access_images/FURLS_GENC_Migration_2021.pdf

Are people still using the older ISO format or the new GENC values, I am not sure if they are 100% identical but they seem now to be two characters now and it would appear this is a recent FDA requirement that may not be followed currently.

Your thoughts ?

Hi all,

Today, while performing P21C validation, I received an error message: 'Incompatible CLI used in the Validation Summary sheet.' This error message did not appear before today. Could it be due to any updates to the P21C system? Do you have any suggestions on how to resolve this error, or can I simply ignore it?

Thank you.

Kind regard,

John

Hi all,

Today, while performing P21C validation, I received an error message: 'Incompatible CLI used in the Validation Summary sheet.' This error message did not appear before today. Could it be due to any updates to the P21C system? Do you have any suggestions on how to resolve this error, or can I simply ignore it?

Thank you.

Is the annotated CRF (aCRF) used in submission required to be the one pulled out from EDC and annotated manually, or is any format of an aCRF fine as long as it includes all the annotations supporting the tabulation datasets and define file?

Hi,

When will SDTM-IG 3.4 and ADAM-IG 1.2/1.3 be available on Pinnacle Community?
If I am not mistaken, FDA supports ADAM-IG 1.2/1.3 since 07/18/2022.
Thank you in advance.

Kind regards,
Joran

Hello,

  From where can I download the community cli jar file?

Dear Community,

How often is P21 community updated per year ? 
When will be available next relesae ? ( new engine, new ADAM or SDTM IG...)

Best,

Cyril

Hello, all is in the title.

The public bitbucket repo seems abandoned (last update 2019-11-08) and only versions until 3.0.2 are available. Do I miss something?
https://bitbucket.org/p21-community/desktop/src/master/

Thanks,
Regards.

What is the difference between FDA(2204.1) and FDA Legacy (2010.1) Engine that we used while validating datasets/define.xml in pinnacle 21 and which Engine is preferable for FDA submission.

Attached a screenshot from the validation report generated by P21 CLI 1.0.6, in the WhereCluase, I specified [LBCAT NOTIN ("COAGULATION" "URINALYSIS")], length at this VLM is 6, value contains NORMAL/HIGH/LOW only, but the report returns an error, seems the validator didn't catch correct records when validating this VLM. Could the team has a look on it? Thank you in advance!