arl_stat ★ India, 2017-05-17 10:42 (2532 d 22:09 ago) Posting: # 17363 Views: 3,149 |
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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 (2532 d 20:23 ago) @ arl_stat Posting: # 17365 Views: 2,516 |
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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 (2529 d 22:10 ago) @ DavidManteigas Posting: # 17375 Views: 2,382 |
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Thank You so much |