PC PP domains for CDISC submission [Regulatives / Guidelines]
Hello,
The concentration and pharmacokinetic datasets you are refering are submited under module 2.7. SDTM and ADaM data are submited in module 5, so I think you should submit both datasets.
Regards,
David
The concentration and pharmacokinetic datasets you are refering are submited under module 2.7. SDTM and ADaM data are submited in module 5, so I think you should submit both datasets.
Regards,
David
Complete thread:
- PC PP domains for CDISC submission Abc123 2017-05-29 12:45
- PC PP domains for CDISC submissionDavidManteigas 2017-05-30 11:19
- ADaM and SDTM files submission question for Generic products Achievwin 2017-07-23 16:01
- ADaM and SDTM files submission question for Generic products Shuanghe 2017-07-24 18:53
- ADaM and SDTM files submission question for Generic products Achievwin 2017-07-23 16:01
- PC PP domains for CDISC submissionDavidManteigas 2017-05-30 11:19
