Define.xml

Can i create multiple whereclause condition like WC_Condition 1, WC_Condition 2. for example i have attached related excel spec. please suggest if we can use multiple WC condition in one variable using pinnacle21 community software.

Dear Team,

I have generate define file through pinnacle21 community V3.0.0 and while reviewing the define file I have got this type of data in ItemOID

Hi,

I have data in my XPT file. When I try to generate Spec using XPT, I get blank excel file.

Hi,

Whenever there is a prime sign in my dataset, I will get errors, i.e.:  Value for IETEST not found in (Inclusion/Exclusion Criterion) user-defined codelist

It seems that in the Pinnacle 21 report got rid of every prime sign in the Value column: i.e.: in the investigators opinion

In my dataset, it is: in the investigator's opinion 

I did mask the prime sign with &#39 when creating define: in the investigator's opinion

I switched my data package from FDA and PMDA to just PMDA and received an error for DD003 - Missing required 'Description' value for 'MetaDataVersion'.

What is metadataversion? Where can I find it?

Hello,

I am trying to validate SDTM Define.xml with PMDA configuration and P21 (2.1.3) keeps crashing everytime I try to validate the define.xml file alone. Any suggestions?

We have created a define.xml 2.0. But while validating the define in Pinnacle, we are getting an error

error id: DD0007

Rule: Define.xml must only contain elements that are defined in either ODM or Define-XML specifications. The elements must also follow the cardinality and order specified in the specifications.

Not sure how to resolve this issue. 

Does anyone have any solution?

Hi All,

I have gone through the forum for this issue. There are responses in general saying that Epoch would fit between visit variables and date variables. So this is the order I have currently:STUDYID DOMAIN USUBJID VISITNUM VISIT VISITDY EPOCH SVSTDTC SVENDTC SVSTDY SVENDY. But I still receive the warning from P21. Please let me know what would be the correct order of these variables in SV. Thanks for your help

I have entered the key variables that define a unique record in our SDTM LB, in Datasets tab of the excel spec. But I still receive duplicate warnings on a different set of variables(LBDRVFL, VISITNUM, LBDTC, LBTESTCD, LBSCAT, USUBJID, LBSPEC, LBCAT) in validation report. I had include the xml in my validator too. How do I get rid of these duplicate warnings? Thanks

Hi,

I wanted to put together a Master Excel Spec for all the domains that reflects all the domains and variables as they are available in SDTM IG tables. So this master spec file could then be used by the spec writers as a starting point, instead of feeding in the XPTs into P21 Community and getting the excel specs.

Then figured it may already exist somewhere and would ask in this forum. Please advise. Thanks in advance.