Changed decoded value

Changed decoded value

Is there a specific reason why you want to do it? By changing the "decode", you are essentially changing the meaning of the coded value ...
BTW, I never assign subset-codelists to domains ("DOMAIN" variable) in SDTM. That doesn't make sense, as the "coded" and "decoded" value are already in the domain name and domain label. So why need to repeat it in a subset codelist that only contains 1 term?

For "NOT RECOVERED/NOT RESOLVED", this is published by CDISC as an "Enumerated Item", i.e. there is no decode (one could also say that code and decode are identical.

You say that "I know "Decoded value" should be used as the NCI Preferred Term of CT", but if you use the ODM files published by CDISC, you always immediately have what you need - no need at all for Excel. Best is to NOT use the Excel files at all. The same applies to constructing define.xml. There are much better tools that do not use Excel, the latter always leading to problems ("black box process").

IF you absolutely want to change the "decode", just open your define.xml in e.g. NotePad++, and change it there.

Hi Narae,

Hi, 

First, please check which version of define.xml is generated. There is a define.xml guideline depending on the version.

And, the guideline will include answers to your questions.

 

Refer to the below:

According to the guidance of define.xml v2.1, 

 

1. About domain decoded values:

In cases where SAS Transport files are the transport format, the value provided in the ItemGroupDef element should match the dataset label provided in the SAS Transport file.

-> Because SDTM CM domain label "Concomitant/Prior Medications" is identical to decoded value as well as CDISC Synonym, you wrote it correctly. 

 

2. About variable decoded values:

The Decode values shown here are taken from the CDISC Synonym field in the CDISC Controlled Terminology publication. The implementation guides for some CDISC standards may recommend use of specific Decode values. In other cases, the choice of the decode is at the sponsor's discretion

->  Collected data in CRF ("Not recovered/resolved" ) is okay to be stated in decode value and it seems to be more specific.

 

I hope it helps you.

 

Best regards,

MinJi

Changed decoded value

Just to get a few things straight here ...
The Define-xml guidance is mentioned, but ...
1. "In cases where SAS Transport files are the transport format ...".
This has nothing to do with code/decode. That section is about labels for the datasets (not domains), which go into ItemGroupDef/Description/TranslatedText. That is something completely different.
2. "The Decode values shown here are taken from the CDISC Synonym field ...".
That sentence is taken from an example. It is not guidance.