SD0063:

Pinnacle 21 Support SDTM
1

Hi Nitin,

Thanks for your catches!

  1. A label for SE.TAETORD will be corrected in SDTM IG 3.1.3 profile as you pointed out.

  2. There are no specific instructions on TSVALn or COMMn variable labels in SDTM IG. However we believe that a reviewer needs to see difference between variable labels. We propose to add underscore char and a number of addition variable as a temporary solution until SDTM team will make clarification on this subject. E.g., TS.TSVAL1 (label= Parameter Value 1)

Kind Regards,

Sergiy

2

Hi This warning shows up for

  1. SE.TAETORD (Label=Planned Order of Element within Arm) Updated label from IG 3.1.3

  2. TS.TSVAL1 (Label=Parameter Value) as used by earlier version of opencdisc metadata file