SD1078 Rmove perimissble varibale with missing value for all records?

Pinnacle 21 Support SDTM
1

Personally, I would in such case ignore SD1078 for the following reason and keep the column in the dataset.
When a reviewer inspects your annotated CRF and sees that you mapped it to your permissible variable, and than doesn’t find that column in your dataset, all alarm bells will ring.
IMO, “plan to collect” (in CRF) automatically means “submit”.

I would also document that all observations have a missing value, either in the Reviewers Guide, or in a “dataset comment” in the CO dataset - or both.

2

Hi,

I have a question about the rules of SD1078:

SD1078: Permissible variable with missing value for all records.

The data of the permissible variable is collected in CRF, but all observations have a missing value, I was wondering if the variable should be remove from xpt dataset?

Many thanks,

Simon