General Discussion

After a submission, we were informed that we needed to rederive a variable in ADSL that is used in a limited number of outputs. Since this is a huge deliverable, it was decided to create a 2nd ADSL dataset to use only for the relevant outputs (rather than rerunning/re-QCing everything). Since all the other ADaMs contain all of the ADSL variables, this will cause a mismatch for this variable between the new ADSL and the other datasets.

大家好，在使用Generate Define时出现“The provided source is not a valid XSLX document”报错上传的EXCEL在其他同事上传是可以正常打开的，检查P21和EXCEL版本均是最新版本，还是出现此类问题，这种情况是什么原因导致的。

大家好，在使用Generate Define时出现“The provided source is not a valid XSLX document”报错上传的EXCEL在其他同事上传是可以正常打开的，检查P21和EXCEL版本均是最新版本，还是出现此类问题，这种情况是什么原因导致的。

Hello all
I would like to install several versions on the same host. But the installation process is removing the previous version and setting up a new one
Could you please clarify to me if there is a chance to set up at least two versions of the Pinnacle app

Many thanks for considering my request.

I am interested in utilizing P21's Custom Terminology feature to store metadata about our company specific CT standards.  As is common in the industry, I've created a custom codelist which is a subset of the NCI NY codelist to store just "Y" values, and I've named it NY_Y.  When this is uploaded to P21, the MD0102 rule (Codelist ID value cannot start with a number and cannot include any special characters.) fires.  Why is this the case?  Underscore characters in codelist names has never been an issue in Defines.

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