Validation Rule Suggestions

Description

This is where folks can suggest additional rules for the Pinnacle 21 Validator.

May 1, 2011

SD0065 is firing even though the records in the LB domain have LBSTAT="NOT DONE". I wouln't expect a record in SV in this case. Would it make sense to only have this rule fire when LBSTAT is null?

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March 23, 2011

Hello,

We are using a FAMH domain which is allowed according to SDTM IG 3.1.2 page 195.

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February 1, 2011

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)?

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December 5, 2010

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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October 28, 2010

Normal 0 false false false EN-US X-NONE X-NONE

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October 25, 2010

I believe this rule is wrong:

<val:Regex ID="SD1011" Variable="%Variables[*DUR,*ELTM,*EVLINT]%" Test="-?P((([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+S)?)?)|[0-9]+W)" Message="Invalid ISO 8601 value" Description="Duration, Elapsed Time, and Interval values must conform to the ISO 8601 international standard." Category="Format" Type="Error" Severity="High"/>

Why? 

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October 15, 2010

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.

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May 10, 2010

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

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April 20, 2010

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

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April 2, 2010

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

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