g Gopal
on

 

Hi,

We are validating define xml with P21-community 2.2.0 version.

Here, we are getting DD0099 & DD0100 warnings when referring the latest ADaM terminology file [2019-12-20, 2020-03-27]. While looking into it, both Analysis purpose and reason are removed in the latest CT file. 

Please suggest how to resolve this.

Thanks in Advance.

Attached Files

Forums: Define.xml

Sergiy
on July 6, 2020

Hi Gopal, 

This terminology was moved to recently introduced CDISC CT for Define-XML. See https://evs.nci.nih.gov/ftp1/CDISC/Define-XML/

Kind Regards,

Sergiy 

g Gopal
on July 13, 2020

Thanks for sharing additional details.

We have SDTM, ADaM & SEND P21 terminologies in the website [https://www.pinnacle21.com/downloads/cdisc-terminology].

Will Define xml terminologies for P21 be listed in the same P21 website?

We can include CDISC CT for define xml & populate NCI codes in the study define xml, but while validating xml with P21 V2.2.0, we are getting DD0099, DD0100 messages, because we don't have define xml terminologies incorporated in P21 V2.2.0. Please correct me, if I misunderstood.

 

Thanks in Advance.

g Gopal
on September 4, 2020

Hi,

We are getting DD0099 & DD0100 / FDAB035 messages while validating define xml ARM section with P21 3.0.2 Community version. 

As per previous discussion, CDISC CT for Define-XML moved separately.

Would like to know, whether this is incorporated in P21 V3.0.2 checks or not.

If not then how to validate ARM Section code list values [Analysis Reason & Analysis Purpose] against CDISC CT? Please suggest.

 

Thanks in Advance for your inputs.

Sergiy
on September 4, 2020

Hi Gopal, 

P21 Community 3.0.2 still has this issue. For validation of Define.xml file with ARM I would recommend you to utilize ADaM CT 2019-03-29 which is the last version with codelists for Analysis Purpose and Analysis Reason.

Sorry for inconvenience,
Sergiy 

g Gopal
on September 6, 2020

Thanks for your valuable inputs and confirmation.

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