Validation Rule Suggestions

I was wondering whether you have any plans to update the validation rules on BLFL  as it has now become permissible, and LOBXFL  has been introduced. Moreover there are ongoing discussions suggesting that BLFL might be deprecated soon. How should sponsors handle BLFL vs. LOBXFL in SDTM datasets to ensure compliance with both current and future validation expectations? I appreciate any insights or updates on this matter!

Thanks

Sri

When validating the LB domain with the define.xml file, we came across a peculiar false positive for the SD1230 check in Community.

The message is "LBORRES datatype is not float when (LBCAT == 'HEMATOLOGY') @and (LBTESTCD == 'BASO' @or LBTESTCD == 'EOS') " and it references the Basophil LBORRES value being ".04".

However upon checking the define.xml, the data type for this value level was already "float" due to the decimal so this is a contradictory validation message.

I am using P21E to check BIMO Clinsite dataset and keep getting issues 'BM0011: Invalid value for FINLDISC variable'. The description is 'A value for Financial Disclosure Amount (FINLDISC) variable must have value that is '>=$25,000', '<$25,000' or 'unknown'. The values of of FINLDISC in my dataset are either '<$25,000' or  '>=$25,000'. I am not sure if there is a bug for this rule? Thanks.

I received error message, "Invalid TSVAL value for PCLAS", where TSVAL = "Vaccine" and TSVALCD = "N0000193912" for my study. I checked MED-RT document and found that the value was "Vaccine [APC]" instead of "Vaccine".

Please suggest if this is the reason caused error message.

Thank you.

Hello,

Can anyone explain the difference Between FDA(2204.0) & FDA Legacy(2010.1) Validation Engine ?

Thanks,

Sahil Patel

The Description of the validation rule SD0065 contains an exception for records where Status (--STAT) is populated. Does this exception also apply to records where the  Occurrence (--OCCUR) is populated? For example in the EC dataset when ECOCCUR = N. If this is the case, could the description of the validation rule be updated to include --OCCUR?

Hi

as i read the various FDA guidlines the only two rules that need to be adhered to in order to avoid a technical rejection are 1734 and 1736. Is this still the case or have other rules been added?

To elaborate a bit further. Especially i TS the start date parameter must be in place. Let's for argue sake say that ACTUB was filled out incorrect. That would not lead to a technical rejection since it won't be checked by a machine.

Hi,

Would you consider adding the following check: '--OCCUR value is populated, when --STAT is 'NOT DONE' ?

Thanks,

Sandra

I see that you can tell me when rules are implemented in each version P21.  But can you tell me which versions of FDA and CDISC rules are implemented for each configuration of P21 Community 3.0.2?

For example, for FDA Engine 1903.1, which CDISC SDTM and ADaM rules are programmed?  And which FDA SDTM and ADaM rules are programmed?  

I think this needs to be a part of the CHANGELOG.txt.

Thanks, Lisa Brooks

SENDIG 3.1 uses controlled terms for MISTRESC, but the validator isn't flagging non-controlled MISTRESC entries. Is it possible to include this?