SDTM

Dears,

I'd like your view on what the DV dataset should include.

The implementation guide says "The DV domain is an Events model for collected protocol deviations and not for derived protocol deviations that are more likely to be part of analysis".

1. Does "collected protocol deviation" mean those deviations highlighted by the CRAs and collected in the monitoring deviation log?

Dear all,

I have a question about SD1212: --STRESN does not equal --STRESC.

I validated my SDTMdata using Pinnacle 21 community ver. 2.1.3 and 2.2.0. (Configuration SDTM3.2(PMDA))

The SD1212 message was occurred

The Pinnacle Community edition version 2.2.0 throws an error for the rule SD1082, ‘Variable length is too long for actual data’, when the variable length is larger than the max data length within a single file.

Can we use the latest controlled Terminologies released for validation for version 2.2.0

or should we wait for new version of Pinnacle 21 community version..

any ideas?

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.