- Stella: In terms of regulatory, if Redcap has trazability entonces sí podemos, pero si no no. Is it possible to sign or countersign. That is one of the things you keep hearing.
- EMA has very strict requirements about software for Clinical trials.
- We can have source documents that are electronic or not, mainly a matter for the teams at GHS and KEMRI.
- The priority is to get the work done and then. We might not do it daily and then the forms will be entered later.
- The priority is to get the work done and then. We might not do it daily and then the forms will be entered later.
- Detection of rare adverese events with a frequency with 1/3000.
- 75 participants from each school para hacer la parte dle estuio relacionada con eficacia.