Validation Rule Suggestions

In the Technical Conformance Guide, the FDA defines baseline flags.  And, even though it is in a section that has a heading that includes SDTM, SEND, and ADaM, the sentence itself only calls out SDTM.

It is very useful that the rules and details tabs of 2.0/2.01 now give traceability to the FDA SDTM rules list v1. We did a deep dive and reconciliation and found some questions arising : 1) FDAC054 (Observation date is after the latest Disposition date for EG, LB, VS) does not appear to be in v2.01 configs. We see FDAC208 and FDAC050 that check dates in AE and EX but FDAC054 is missing. Have we identified this scenario correctly ? If so – is this intentional – we would like to understand why.

SD2236/FDAC197 is present in 2.01 for ACTARMCD^=ARMCD. However, SD2237 from 1.5 to check ACTARM vs ARM has been retired and is not in 2.01. Is there a rationale for this please ?

The rule for SD2242 refers to TSPARAMCD for TSVCDREF. In the IG TSVCDREF is based on TSVALCD. When the PARAM is based off the protocol we are not putting in the TSVALCD and so get an error when it is acceptable to have a blank value for the expected variable. Should the rule result in a warning and also be based on TSVALCD rather than TSPARAMCD?

Thanks

(it is for rule SD2240)

In the SDTM TV dataset, the variable ARMCD exists but no ARM variable exists.  The ARM variable in the study define.xml file has been listed as a key.  However, when the OpenCDISC Validator executes using both SDTM + define.xml, no errors are fired to indicate this problem.  Maybe the errors SD0054, SD0058, or SD0059 should have fired?  Not sure if maybe another rule should have fired?

QEVAL is an Expected variable in SUPP-- domains in SEND, not Permissible.

 

Dear,

 

OpenCDISC is expecting fixed length for few variables mentioned in SD1057/8/9 rules.

 

If we consider the rule 1081 for ALL variables then we can produce optimum size of file. what do you think?

Thank you.

Regards,

Santhosh.

Hi all,

I suggest to have validation rules that check the consistency of start and end date / start and end day:

1. if both --DTC and --ENDTC are fed, --DTC should be before --ENDTC;

2. if both --DY and --ENDY are fed, --DY should be before --ENDY;

Something similar to the rule that checks for the animal start date to be before the animal end date.

What do you think?

Hello,

I'm getting the CT0082 and CT0082r errors when validating a dataset without specifing its define.xml. Everything related to CT works fine when I'm specifying define.xml.

Can you please provide some clarification related to this rule? To what "Code in CDISC CT" it refers to?

Best regards,

Amelia