Multiple Standardized Units requested by sponsor

Pinnacle 21 Support SDTM
1

Hi Adam,

There is no standard way to handle such request for having results in both SI and US units. I saw cases when Sponsor used standard variables LBSTRESC/N/U for one units and provided results in other standard units in SUPPLB domain.

Please note, that there is a big difference between FDA (CDISC) and Sponsor standards. The Sponsor standards may be flexible to handle their specific internal process. For example, extra variables in LB domain may be OK! and more useful for reporting purpose. Later during data preparation for regulatory submission all “extra variables” will be moved to SUPPLB domain.

It’s purely Sponsor’s decision. Propose them several options with listed Pro and Cons. Let Sponsor chose what do they like better? “Submission ready” or “analysis ready”?

Kind Regards,

Sergiy

2

Thanks Sergiy!

3

Hi, I have a sponsor who needs the original units (a mix of CN, US, and SI units), Conventional units, and SI units all within the lab data for a study. I’ve never come across the situation where I’d technically need two sets of LBSTRES variables in the SDTM data before. I considered sending one set of results and units to SUPPLB, or even making a “non-standard” findings domain for the other units. These do not seem optimal. Is there a preferred solution to this issue? This is a large programming undertaking, so I’d like to get a compliant solution before executing a programming plan and running OpenCDISC. Thanks!