SD1047

Pinnacle 21 Support SDTM
1

Hi Saurabh,

When you know exact dose you populate --DOSE value only.

When a dosage is collected as a range and its exact value is unknown, you populate --DOSTXT only.

Regards,

Sergiy

2

Hi,

This is regarding rule SD1047, Only one of Dose (–DOSE) or Dose Description (–DOSTXT) variables must be populated on the same record.

Is there any particular reason for this check?

Because as per SDTM Ig EXDOSE: Amount of EXTRT administered or given. and EXDOSTXT: Dosing amounts or a range of dosing information collected in text form. Example: 200-400.

So, in second case when we have dose range in exdostxt, we need to populate actual amount of dose in EXDOSE variable, but SD1047 check will throw error Both EXDOSE and EXDOSTXT values are populated.

Thanks and Regards,

Saurabh