SDTM

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

When validating, I get CT2002 "Variable value not found in extensible codelist" for a questionnaire I have used in previous studies and which I am planning to use in future studies. I cannot find a corresponding QSCAT variable value in the CT so I am looking to have it added. I believe the correct way to add a new term to the CDISC controlled terminology would be to make a request through the NCI at https://ncitermform.nci.nih.gov/ncitermform/. Could you please confirm?

Hi,

In SDTM PC, I have PCSTRESU unit "ng/mL". "ng/mL" is standard PK Units of Measure C67306. I am getting warning for CT2002 rule, because "ng/mL" is part of "PK Units of Measure" not "Unit".

Is there any way to resolve this warning?

Thanks,

Saurabh

Pinnacle21 Community reports show SD1077 (FDA expected variable not found) as a "Warning".  The Enterprise Validation Report shows SD1077 as an "Error" in the FDA column.  

The validation rules on the website also show SD1077 as a Warning: https://www.pinnacle21.net/validation-rules/sdtm. 

I'm getting this error because Epoch is not included in SV. The study is following version 3.1.3 of SDTM.

I wanted to confirm that this is now considered an "Error" for purposes of the SDRG.  Or would this be considered a "False Positive"?

Thanks

Hi, I found the term and code in the NDF-RT dictionary, but I am still getting errors in Pinnacle 21. Is the dictionary up to date?

TSVAL=Antibodies, Monoclonal and TSVALCD=N0000011174. Does anyone know why I am still getting errors in the Pinnacle 21 report?

Thanks.