Validation Rule Suggestions

Description

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

March 22, 2010

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.

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March 19, 2010

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.

 

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February 27, 2010

Hello,

SD0026 is very helpful because it identifies the xxCAT. Typically, when the xxCAT is COAGULATION or URINALYSIS I know I can ignore the message since most results in these categories will not have units.

Can you add xxCAT information to SD0029?

 

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February 27, 2010

Hi Team,

My DS domain contains an invalid variable SUBJID. SD0058 fires correctly but I am also getting SD0055. SUBJID is a char variable so I do not think it should be on the report since SD0058 identifies the issue.

In general, if a variable exists in a dataset when it should not according to SDTM, the OpenCDISC report incorrectly outputs SD0055.

 

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November 14, 2008
Here is a list of some of the checks we find helpful at our company in addition to the defined IR---- and R---- checks: Number - Error Message 1 - User variable is not defined in SDTM. 2 - Variable _____ is a REQUIRED variable in this domain and should always be included in the dataset. 3 - Variable _____ is an EXPECTED variable in this domain and should always be included in the dataset. 4 - Variable is a PERMISSIBLE variable in this domain but is null for all records. If no data is anticipated, drop _____.
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