SDTM

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.

Can someone in the group provide me a solution to the issue described below?Here's the issue:

 DS Domain

1. SubjectID    EPOCH                   DSSTDTC
2. xx-xxx        SCREENING            2016-03-31T10:36
3. xx-xxx        TREATMENT            2016-05-05
4. xx-xxx        TREATMENT             2016-07-28

EX Domain:

In my customer's submission I get a lot of warnings for MH "Missing values for --STDTC, --STRF and --STRTPT, when --ENDTC, --ENRF or --ENRTPT is provided" (FDAC122). The MH dataset in this case has an MHSTDTC column (sometimes with NULL values) but no MHSTRF nor MHSTRTPT column.
Each time MHSTDTC is null, but either MHENDTC or MHENRF is not null, I get this error.
I looked in the SDTM-IG 3.2, and there are examples which exactly matches this situation (examples 1 and 3 on pages 156 and 158), so I wonder whether the rule is more severe than the SDTM-IG.

Do you have any recommendation on the version of the CDISC CT to use?

-Should we use the closes version that match the setup of the collection database?

-Should we use the most recent?

-Will the FDA, PMDA use the same version identified in the reviewers guide (SDRG)?

Hi,

after getting Warnings in Pinnacle 21 Community validator for SE variables in wrong order I had a look into config/SDTM 3.2.xml and found that for some of the SE variables the order defined there is not consistent with corresponding SDTM IG:

According to the SDTM IG 3.2 the order is:       ...-ETCD-ELEMENT-SESTDTC-SEENDTC-TAETORD-EPOCH-SEUPDES-SESTDY-SEENDY

According to config/SDTM3.2.xml the order is: ...-ETCD-ELEMENT-SEUPDES-TAETORD-EPOCH-SESTDTC-SEENDTC-SESTDY-SEENDY

Thus, the warnings we get seem not to be in line with SDTM IG 3.2

Hi,

is it possible to load a more current version of NDF-RT than is included in the Pinnacle 21 Community 2_2_0? The NDF-RT is updated monthly, thus the version from 2016-09-08 the validator goes with is not the most current one.

Does anyone know where to get the new version? How to include it into the validator?

Thanks in advance!

Heidi

Hi,

to validate SDTM data using Pinnacle 21 Community 2_2_0 we would like to use a more current version of CDISC CT, e.g. the one from 16-Dec-2016.

Is this possible and if so, what do we need to do exactly to have it available within the validator?

Thanks, Heidi