Validation Rule Suggestions

I got a custom dataset containing --TEST and --TERM, a clear violoation of SDTM. When I ran OpenCDISC no issues were reported. Can OpenCDISC validate the structure of of a domain when it contains both a Findings TOPIC variable (--TEST) and an Events TOPIC variable (--TERM)?

Dear Sir/Madam,

After running OpenCIDSC SDTM validator. I fournd that in output file tab Rules SD0008 is not included. Probably it is a CT rule?

Thanks!

Lin Yan

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Dear Max and Tim,

First of all, thanks for the great product – SDTM validator! It is very useful and convenient.

According to SDTM IG 3.1.2, section 4.1.5.3.1, IETEST values in IE and TI are exceptions to SD0017.

Hi.  I am new to using openCDisc.  Just downloaded and trying to test it in my system and finding that the rule SD1001 - Duplicate SUBJID pops up.  My question is the SUBJID doean't have to be unique if the SITEID is different.  In my dataset, the USUBJID is different for all the subjects.  But I have SUBJID 001, 002 for 2 SITEIDs (01, 02).  When I look at the Implementation guide example for the DM dataset, i do see SUBJID of 001, 002 multiple times with different SITEID.  Since this is marked as HIGH severity, would like to check this with this group.&nb

On SDTM Implementation Guide 3.1.2 page 253, TSVAL="SUBJECTS DIAGNOSED WITH DISEASE" where TSPARMCD="TDIGRP".

In OpenCDISC SDTM Terminology.txt file, only one value can be found in code C66787, i.e., "HEALTHY SUBJECTS". Can you consider extending that codelist? Thanks,

Sandy

Hi,

I had a two part question/suggestion. I noticed there were no checks for any --STDTC being greater than --ENDTC in any domain. Is this something that will be added in a future release? I can modify the config files to add this rule in there, I just thought it might be an important rule to check, and thought it was present in the WebSDM checks.

Thanks,

Peter

For the study I'm currently working on there are subjects that were randomized but for whatever didn't receive the study drug (some withdrew before taking drug, others failed screening criteria after the fact). In this case they are randomized however they did not receive any drug. Now it make sense to me that RFSTDTC be calculated the same for all subjects so in my case the RFSTDTC value would be missing since I'm basing it off the start of study drug.

Hello,

I am trying to prevent a rule from running on a particular domain by customizing the config file but I am unable to get the desired results. Can you help. I added the 'when' statement to SD0017 but I still get the message in the Excel file. Our company has a special domain called MQ and the lengths of MQTEST are always longer thatn 40 so I want this check to be ignored for that domain.