General Discussion

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!

Hi,

Define.xml file created using P21 Community I can only view either with IE or Edge with IE option. Can we use any other browser as IE is not going to be supported by microsoft any more. Please suggest.

Thank you,

Uma.

I have a situation in which we have an ADSL for an ISE. We want to also use the same ISE data but add some Natural History population flags and new analysis parameters. Would be okay to add these population flags to a dataset called ADSLNH that contains the core variables in ADSL plus the new Natural History population flags? It would be  subject-level-dataset. So, I'm not sure if it will throw a P21 error for having 2 subject-level-datasets.

Any advice is helpful,

Lisa

Hi everyone,

I have recently started working on the CDISC Files preparation for bioequivalence studies (BE) (For FDA submission).

I wrote required SAS codes to generate all the SDTM and ADaM required domains. I have tested these codes against related CDISC and FDA guidelines for different BE studies using SAS OnDemand for Academics_ SAS studio.

My questions are the following: