SDTM

I am confused about business rule FDAB036 which says "Study Day must not be negative" for EX. This rule is different from the SDTM IG rule which is Study Day must be >=0. I have been given a study where the protocol and SAP definition of Study Day is date of first dose is Day 0. The SDTM datasets used the SAP definition of Study Day instead of the SDTM IG definition of Study Day. Day 0 in the EX dataset meets the requirement for the business rule because all the study days in EX are >=0.

Today I was reviewing an SDTM of a swiss customer. In my own implementation of the FDA-SDTM rules, violations were reported for some of the "Missing XXX Trial Summary" parameter. I looked into these and found out that all these records had a value for TSVALNF (i.e. TSVALNF populated) but TSVAL was null.

Hello,

There is an error in AE domain: No Treatment Emergent info for Adverse Event.

The description of rule 1097 states, it should be included in SUPPAE. But there is no imputation done at sdtm level, so how can one create emergent flag?

Thanks,

Abdul.

There is a missing letter "I" for VISIT in the XML file:

            <EnumeratedItem CodedValue="C-SSRS CHILDREN'S SINCE LAST VIST">
               <Alias Name="C111379" Context="nci:ExtCodeID"/>
            </EnumeratedItem>

CodedValue should be "C-SSRS CHILDREN'S SINCE LAST VISIT"

This appears to be corrected in later versions.  I am trying to finalize a study with this version of CT - any chance that this will be updated?

Hi,

I am getting an error:SVSTDY variable value is imputed.  In the details tab in pinnacle report under column B it stated Null value of RFSTDTC, but in the dataset it does not have missing value. This error is generating mainly because RFSTDTC and SVSTDTC are exactly same and due to mathematical operation +1 has been added as there is no day 0.

Please suggest how to handle this.

Thanks,

Abdul

Hi, 

I would like my data to be compliant with SDTM version 3.1.2 Amendment 1. I do not see this option in the P21 validator. If we use Configuration = 3.1.2 (FDA), will amendment 1 compliance issues be missed?

Thanks.

Hello,

I am receiving error SD2023: AGE is not provided [Age (AGE) variable values should be provided, when Date/Time of Birth (BRTHDTC) variable values are populated.]

But according to IG 3.2 DM-Page No: 6; DM Example 1 – General Demographics, I may not have AGE values for screen failure subjects even though having BRTHDTC information.

Can you please look into SD2023 validation rule? 

Thanks

Saurabh

I hope someone here can help to clarify what the industry standard is regarding tabulation of collected data (eCRF, eDiary, eDT, IVARS, ECG and so on). I believe it is common understanding that data like

System generated data like CRF name or page numbers etc., which is not actively collected

NOT DONE records

Any AE, or Any Medical History information

does not need to be tabulated in SDTM, right?

Hi,

I am just wondering what set of characters that Rule FDAC216 accepts? Does it only accept wlatin1?

We're having issues with validation findings about variable label mismatches, and in a few of the cases I'm not sure what's wrong.  I'm not sure if this is possible, but is there any way for the P21 report, when it says that "X is not the value we expect it to be" to also report what that expected value is?  It's clear that for a particular variable there's a specific string P21 is expecting in the label, and if this expected result were part of the report then troubleshooting and fixing would be a lot more straightforward.