h Hoa
on

 

Hello all,

I wonder which domain and variable to map Cycle number for a oncology trials. Or it should be not submitted.

Thank you.

 

 

Forums: SDTM

j Jonathan
on October 1, 2019

I don't think there is any set way to do this - I don't recall seeing it in any of the various Cancer TAs.

For myself, as a Cycle will normally start with a visit I would encapsulate the Cycle into VISIT and VISITNUM

If there is only a single visit per cycle - I would probably use something like
VISIT = Cycle x
VISITNUM = x

However, if the protocol calls for multiple visits per cycle, e.g. days 1, 15, 28 in each Cycle I would probably use something like
VISIT                            VISITNUM
Cycle x, Day 1             x01
Cycle x, Day 15           x15
Cycle x, Day 28           x28

 

That way Cycle number is embedded into VISITNUM in a consistent way, and can be later extracted into an ADaM variable if required.

h Hoa
on October 2, 2019

Thank you.

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.