Great explanation!!!!!!!! Please upload videos on ISS/ISE , Pinnacle21 error resolution, Partial Date imputation in ADaM, MedDRA version upgradation for Integration, WHO drug dictionary merging with CM domain. Thanks!!!
Thanks for your kindly sharing. I have another question. In a study("A Phase 1, randomised, double-blinded, placebo-controlled, dose-escalation study..", it has two dosing group(low/high) and Placebo group, however, there are two age group(younger/elderly) for each dosing group(low/high). In above case, how many arms in TA domain? 3 ARMs(low/high/placebo) or 5 ARMs(low-younger/low-elderly/high-younger/high-elderly/placebo)? Wish for your advice.
I think, we can go with 3 arms - low, high and placebo.. for analysis purposes, age groups (younger and elderly) can be considered as stratification factors within each treatment arm..
Subject level treatment information will be mapped SDTM.DM domain. ARM will be used to capture the planned treatment sequence and ACTARM will be used to capture the actual treatment sequence. You can find an example of DM dataset in one of the ADaM lessons on the website. www.mycsg.in/adam.php?area=ADaM&concept=C1001&lesson=ADaM_C1001_L103a