Validator 1.4 new validation criteria?

 Hi Amelia,Thanks for

Hi Amelia,

Thanks for identifying a standard metadata definition issue for SEDN validation. We don’t use external CSV files as a source for standard metadata anymore. Unfortunately for SEND this transition was not very successful for several reasons. The major one is a lack of SEND data for testing purposes, which lead us to miss this config specs bug during testing.

We are working to fix SEND metadata and  replace existing package ASAP.

1. It’s a bug with incorrect SEND metadata.

2. According to SDTM IG and SEND IG the only allowed values for variables of SD1054 check are 'Y' and NULL. 'NA" value should not be used there.

3. See "CDER Common Data Issues" document. It is considered as a FDA Guideline. 

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM254113.pdf

See page 12

4. Yes. it's quite controversial. However we decided to keep it like this. This issue is still under discussion. I think, that --TEST, --TESTCD, etc. variables should be excluded from SD1080-82 checks and still have their own exclusive business rules.

5. It’s a metadata bug in our specs

6. It’s a metadata bug in our specs

7. I am not sure. It’s a part of “CDER Common Data Issues" document and PhUSE working group request. The actual business rule is that you need to have both Study Reference Start Date and Data Collection Date values, which both include complete date part to calculate Study Day. Otherwise it’s considered as imputation of data values, which is not allowed in SDTM/SEND.

Regards,

Sergiy

Hi Sergiy, Thank you for the

Hi Sergiy,

Thank you for the clarifications.

I'm looking forward to test the updated package.Please let me know when it's available and I would be more than happy to give it some tests and to report anything that looks "suspicious" to me :)

Thanks again. Keep up the good work!

Amelia

Thank Amelia! The real reason

Thank Amelia!

The real reason we got this issue with SEND profile is that we do not have enough real SEND data because SEND adoption level is very low compare to SDTM. As result out test cases did not catch some wrong SEND metadata specifications.

We will be very happy to provide updated version of SEND validation profile to you before official update. I'll contact you later.

Thank you again!

Sergiy

New observations

Hi Sergyi,

Some observations based on the latest downloadable version. I see some changes in the SEND section, but I'm still noticing some issues:

- BG: BGSTRESC variable not added in BG ItemGroupDef => SE0058    Variable appears in dataset, but is not in SEND standard
- DS: DSDECOD still not added in ItemGroupDef for DS => SE0058    Variable appears in dataset, but is not in SEND standard
- BG: VISITDY added but not in SEND standard => SE0057    SEND Expected variable not found
- TS: STUDYID and DOMAIN are in wrong order => SD1079    Variable is in wrong order within domain
- MI: MILAT label should be "Specimen Laterality within Subject"
- LB: LBORNRLO, LBORNRHI should have numeric type, not text in ItemDef entry.
- LB: LBDY, LBENDY have different labels than the ones from SEND specs.
- SE2201 should have same Severity as SE2202, SE2203, etc ("Warning").
- SE0015, SD0026, SD0029 should be disabled for SC and PM - see older discussion: http://www.opencdisc.org/forum/se0015-missing-stresn-value-and-sd0026-missing-units-value
- TA: some ItemRef are not in order. When define.xml not specified => SD1079 - Variable is in wrong order within domain.

- Error SD0037    Value for TXPARMCD not found in (SEND Trial Summary Parameter Test Code) user-defined codelist is wrongly reported for TXPARMCD = 'GRPLBL'.

Best regards,

Amelia

Disregrad observation: "- LB:

Disregrad observation: "- LB: LBORNRLO, LBORNRHI should have numeric type, not text in ItemDef entry." 

The type is numeric in SEND 3.0 but apparently it will change to text in 3.1