Define.xml

Hello,

I come through a figure case for this define rule, and I would welcome any suggestion.

Here is the situation: I have the variable LBSTRESC declared globally as text, length = 9.

* where LBTESTCD = HCG, I have VLM text, length = 8 and codelist = POSITIVE/NEGATIVE.

* where LBTESTCD ne HCG, I have VLM float, length = 12.7, hence the message since "how can 12 digits fit into 9 characters?"

When a variable is derived and has multiple methods associated with it, I have outlined the methods in the ValueLevel tab of the Excel spec with the respective where clauses. However, I am wondering what to put in the "Method" column on the Variables tab for the variable in question. Do I leave it blank or is there something I put in that column to indicate that the ValueLevel tab has the details of the derivation?

I have created an Excel spec using Pinnacle Community and hope to convert that to a define.xml file using the "Generate Define" tab. To test out the functionality, I have only included 1 dataset and have filled out all the tabs in the Excel. I wanted to confirm I am completing the Excel properly before I replicate what I've done for every dataset. I then tried to upload the Excel to generate the define.xml, but I keep receiving the same error code:

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...