Hi Thierry,
P21 AD0018 rule compares variable label to ADaM specs. Any added text in label is now considered as deviation from standard value. So, expected value is "Analysis Flag 01". We plan to adjust the algorithm. However, it's not done yet.
Sorry for inconvenience.
Kind Regards,
Sergiy
Hi,
We are validating an ADaM submission against ADaM IG 1.1, and got AD0018-18 for the ANL01FL "Analysis Flag 01 - AE of Interest".
Per ADaM IG:
Or are we missing something?
Cheers
-- Thierry