What is your root cause? [Study Assessment]
may I ask if you did a root cause analysis and if you did, were you able to assign a root cause to this case?
The RC determines the CAPA. In the absence of a really good RC here, the CAPA could be quite impossible. If nothing is done, it could happen again, so obviously something's gotta be changed here.
I could be wrong, but...
- SAS code for the mixed effects model with sequence mistakenly assigned libaiyi 2019-04-19 09:32 [Study Assessment]