SD1079: wrong order for added variables in SE

Hi Cathy,  It's quite

Hi Cathy, 

It's quite confusing.

CDISC SDTM model defines an order of Timing variables as ...TAETORD, EPOCH, --UPDES, ..., --STDTC, --ENDTC, ..., --STDY, --ENDY, ... 

However SE is not a General Observation Class Domain. 

In SDTM IG  the standard timing variables for SE domain are ordered as --STDTC, --ENDTC, TAETORD, EPOCH, --UPDES. There is an inconsistency with SDTM Model General Obs. Class Variables. However there is no formal requirements on order of variables for Special Purpose domain.

Therefore SDTM Model and IG do not provide complete information on this topic.

In current version of OpenCDISC specifications the order of SE Timing variables was set as 1. defined in IG for standard variables 2. then followed as defined in Model for other model permissible variables.

I realize that it is not 100% valid and not sure what is the correct answer.

I think that CDISC team needs to modify SDTM IG to make an order of variable consistent for all domain inclduding Special Purpose ones.

Kind Regards,

Sergiy   

P.S. This is an order of variables in OpenCDISC specifications:

• SESTDTC

• SEENDTC

• TAETORD

• EPOCH

• SEUPDES

• VISITNUM

• VISIT

• VISITDY

• SEDTC

• SEDY

• SESTDY

• SEENDY

• SEDUR

• SETPT

• SETPTNUM

• SEELTM

• SETPTREF

• SERFTDTC

• SESTRF

• SEENRF

• SEEVLINT

• SESTRTPT

• SESTTPT

• SEENRTPT

• SEENTPT

Thanks Sergiy!  It's

Thanks Sergiy!  It's different than what we expected, but now we know how to avoid the error.

I would like to say it again.

I would like to say it again. Our order of variables is not correct as well. Unfortunately there is no clear standard specifications on that. 

I refer to a temporary OpenCDISC interpretation only.

Regards,

Sergiy

SESTDY Label

Can you please specify what should be the accurate label for SESTDY and SEENDY?

View validation metadata in IE with provided stylesheet

Hi Liron,

If you need to look at Pinnacle 21 specifications, there is an option to use Internet Explorer with a provided stylesheet. It's similar to reviewing define.xml file in a browser.

Go to ...\components\config folder of P21 Community tool. Select any specific validation configuration file and open it with Internet Explorer. It gives you user-friendly view of standard metadata and rules assignment to each domain. Variable Labels are a part of standard metadata used for validation.

Kind Regards,

Sergiy 

Metadata labels

Thank you. That would be very helpful for few other questions as well :)

changes in 2.2.0

Hi

The order of SE variables has been changes in 2.2 vs. 2.1. In particular, the order is now SEUPDES TAETORD EPOCH SESTDTC SEENDTC, while it was SESTDTC SEENDTC TAETORD EPOCH SEUPDES, which matches the SDTM 1.4 & SDTM-IG 3.2. What is the reason for this change? Should be follow the SDTM(IG) or your order?

Best,

-- Thierry

SE variable order change

Up...

Any news on this?

Best

Within a month

Hi Thierry, 

A new minor release is expected within a month.

Regards, 

Sergiy

SE variable order inconsistency addressed in SDTM IG 3.2 Errata

The inconsistency between the SDTM 1.4 model document and the SDTM IG 3.2 is addressed on the SDTM 3.2 Errata page on the CDISC Wiki:

https://wiki.cdisc.org/display/PUB/SDTMIG+v3.2+Errata

The published corrected order for the last six variable in the SE domain in the IG is ELEMENT, TAETORD, EPOCH, SESTDTC, SEENDTC, SEUPDES.  The timing variables appear to have been reordered to be consistent with the order of standard timing variables for general observation classes, but SEUPDES remains the final variable in the domain.  This implies that the correct order for all eligible SE variables should be:

• Identifiers
• ETCD
• ELEMENT
• Timing variables (in standard timing variable order)
• SEUPDES.