General Discussion

Hi,

I am wondering. What is the rationale in 1.4.1 that has lengths tested strictly for SDTM to avoid excess, and does not do the same check for ADaM datasets? I'm not sure why excess is okay for one and is impermissible in the other.  Note I am not requesting or advocating for more length checks for ADaM.

Thanks!

Joan

We are developing dataset of SDTM/ADaM/SEND/define.xml following OpenCDISC Validator v1.3

The version we followed is as below
* SDTM 3.1.2 Amendment 1
* Define.xml 1.0
* ADaM 1.0
* SEND 3.0

However, the version of validator and rule is updated as 3/14

Dear All,

I have a question regarding appearance of labels for suppqual and custom domain for SDTM xpt files. When I run OpenCDISC on SDTM xpt files, for suppqual domains it shows labels as "Supplemental Qualifier" and for custom domain instead of showing label it shows class as its label such as "Findings".

I have tried labelling suppqual as "Supplemental Qualifier - LB" and "Supplemental Qualifier [Laboratory Test Results]". In both case, labels appeared as "Supplemental Qualifier".

Hi All

When readying the Using OpenCDISC Valiudator topic and reading the text below

Is FDA ready for the new TS?

Hi All,

As i new with cdisc so just want to know. what make different if we use define.xml confi. during for CDISC DATA VALIDATION 

Thank you

Dear all,

I just wanted to know if the FDA is OK to receive data with amendment 1 now or if they are still based on SDTM 3.1.2 ?

Thanks for your help !

Melanie

Hello all,

Where can I find a more detailed description of the messages level as included into the validation report?

I assume that the presence of an Error in the validation report means that FDA will not accept that submission. Is this assumption correct? And what about Warnings? They must absolutely be corrected before the submission, or the dataset will be accepted by FDA even though the validator reported some Warnings?

Thank you!