Define.xml

There is no <Purpose> column(Datasets tab) when using the P21C to generate the define xml. Also confused that how P21C populate this info.

Wish for your help, thanks in advance.

https://www.lexjansen.com/pharmasug/2018/AD/PharmaSUG-2018-AD29.pdf

Hi,

I'm validating a Define-xml v2.1 using P21 Community 4.0.2, engine FDA 2204.1

I have a validation message "Invalid use of Pages" for variable CMCAT, apparently because I reference a CRF page for an assigned variable. 

How to set the type of variable RDOMAIN in SUPP-- dataset based on define V2.1? Based on the example of define V2.1.5, the type of this variable RDOMAIN is "Derived". However, RDOMAIN is not calculated from ANY variable with the formula. Is it more likely to "Assigned"? So, is there a clear definition of the type for variable RDOMAIN?

Example of define V2.1.5:

Hi,

Based on Define V2.1 origin for SDTM dataset, please help to discuss the type of --STRESU for VS, LB，EG domain and so on, if the standard unit was not collected in the CRF. Here are 2 options, "Derived" or "Assigned"? Moreover, how about other ambiguous variables, such as AVISITN/PARAMCD/PARAMN?How to distinct the type of "Derived" or "Assigned"? Thanks!

Option 1: TYPE as "Derived". Follow the Define-XML-2-0-Specification.pdf as below, the type of VSSTRESU is "Derived".

Hi all,

I am using the Define.xml Generator from Pinnacle Community to create my define.xml. When I fill out the Excel Spec to create the define, the following issues arise:

1. I cannot reference to the section of a document but only to pages (by using the column "Pages" in e.g. the Comments tab).

2. I cannot reference two documents within the same comment.

In the define.xml it should look like this:

Hi all -

Please forgive the very BASIC nature of my questions, but I'm looking for information or documentation on where and how to begin filling in the missing info on the various tabs of the Define.xml spec that is generated by Pinnacle 21 Community. 

We have 36 SAS transport files representing SDTM domains and SUPPXX domains.  We have run them through the validation part of the software, eliminated the issues we could and addressed the rest in the SDTM Reviewer's Guide, EXCEPT for the global issue that indicates we're missing the Define.XML file.

I've somehow never noticed that I often write Where clauses without text in quotes when it comes to PARAMCD.  Not sure how I have been so inconsistent.  But somehow, it seems to work:

where PARAMCD = SYSBP

instead of PARAMCD = "SYSBP".

Why does this work without the quote marks?  Ha ha, this is really bothering me not knowing.  In the future I will use quote marks regardless...

Hi All,

We're in the process of validating a data package (incl. define.xml) and the warning DD0148 is being triggered. Interestingly, I couldn't find any additional information about this rule in the set of validation rules (Define-XML Validation Rules | Pinnacle 21) but that's not my main concern.

Dear,

I created one define spec from define.xml in Pinnacle 21 community, and there are two records for APQS domain in ValueLevel tab, as shown below.

Hello. This is related to style sheets for Define.xml 2.0 ADaM. I'm having trouble locating a style sheet that does everything I want it to. Thought I would reach out to the community before I try to change ours. What I am finding is there is a group of style sheets that works with all browsers like Chrome, Edge, IE. However, the stylesheets I've found do not allow for links to the adam reviewer's guide to go directly to a specific page. They all go to page one.