arl_stat
★    

India,
2017-05-17 10:42
(2527 d 21:24 ago)

Posting: # 17363
Views: 3,130
 

 CDISC domains [Regulatives / Guidelines]

Post reply
Hello Everybody,

Greetings to all!!

This is regarding the new CDISC requirement.

Is there list of domains that are mandatory to submit with this current requirements for BA/BE studies?


Thanks in advance.:-)
 
DavidManteigas
★    

Portugal,
2017-05-17 12:28
(2527 d 19:38 ago)

@ arl_stat
Posting: # 17365
Views: 2,499
 

 CDISC domains

Post reply
Hi arl_stat,

I'm not aware of any guidance stating which CDISC domains are "mandatory". From my perspective (and CDISC perspective also), you must submit all data collected under SDTM domains (except those used for operational purposes only, such as check questions). What you may ask, and it will depend on your personal view, is which ADaM datasets are necessary.

Regards,
David
 
arl_stat
★    

India,
2017-05-20 10:41
(2524 d 21:25 ago)

@ DavidManteigas
Posting: # 17375
Views: 2,364
 

 CDISC domains

Post reply
Thank You so much:-)
 
UA Flag
Activity
 Admin contact
22,986 posts in 4,823 threads, 1,660 registered users;
55 visitors (0 registered, 55 guests [including 2 identified bots]).
Forum time: 08:07 CEST (Europe/Vienna)

Art is “I”; science is “we”.    Claude Bernard

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5