SDTM

Hi, For the extensible codelists for LBTESTCD and LBTEST, this message is firing as an Error for every term beyond the codelist.  It seems the behavior in 1.3 was much more appropriate for the extensible codelist.  Will it be fixed in the update?

Thank you!

Regards,

Joan

I tried the new validator with 3.1.3 yesterday (thank you for all your effort on getting this done) and found some strange things:

 

I think its meant to look at AESOCCD, but it appears to be looking at AESOC.  Obviously none of the SOC names will match the codes.

In Opencdisc version 1.4, quite a few rules have been added, one of them is SD1082.

Hello Everyone,

I am here with question regarding one of the warning I received in OpenCDISC report as mentioned below:

We are using OpenDISC Validator 1.3  I have copied the licensed MedDRA Ascii files into their separate sub-folders (14.0, 14.1, 15.0 and 15.1) as instructed in your documentation “Configuring OpenCDISC Validator for MedDRA”.   I get the following error:

We recently ran across an issue where a date was incorrectly generated like this: 2012-10-10T12:-- (Note the trailing dashes) It was caught on manual review, but I am surprised that check SD0003 did not fire, as this is not a valid ISO date.

The Description has the following text in parenthese:

(outside of 32-127 ASCII code range)

I think there is a typo

I think the correct value for second number should be 126

Sorry if this is posted somewhere already or covered in documentation ... perhaps I missed it.  Does the SDTM validator re-attach the SUPPxx data sets to the parent domains, thereby checking the content of SUPPxx as opposed to jsut the structure of SUPPxx?

Hi all,

I thought that there was an error check for the uniqueness of TEST/TESTCD. (They had to match 1-1)

We had a study with the following error, and we I cannot figure out why we didn't get an error with OpenCDISC Validator.

I understand in they example below that UNIT1/UNIT2 don't belong as part of the TESTCD.

However, I don't understand why we didn't get this an error in the OpenCDISC Validator Report.