SDTM variables, defined for use in human clinical trials, do not fit the SEND model and must NEVER be used in the submission of non-clinical studies

They are used by SE1074 check

Hi ARLIX, 

These variables are present in P21 validation specs for validation purpose and utilized by SE1074 check as an explicit list of "Variable which can be used only in SDTM"

Note that "Appendix E" you refer to is a part of SEND IG 3.1. However, it does not exist in SEND IG 3.0. That's why some of these variables are not considered as "SDTM Only" in P21 specs for SEND IG 3.0.

Regards, 

Sergiy

Thanks for the explanations…

Thanks for the explanations.

Will a P21 specs for SEND IG 3.1 be implemented ?

Regards,

Sophie

Enterprise - available now, Community - in few months

Hi,

Original P21 specs for SEND 3.1 was implemented as a draft a while ago and are already available for Enterprise clients including FDA.

Community version depends on official rules published by CDISC, FDA or PMDA. CDISC does not plan to develop rules for SEND 3.1 data in the nearest future (2020+?) 

We expect an FDA update of their business and validation rules for submission data in the next few months. This upcoming version will include SEND 3.1.

Kind Regards, 

Sergiy