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1.2 KiB
1.2 KiB
- Jose Muñoz y Almudena
- The main target is safety, then effectiveness of STH. Scabies is neglected even between NTDs.
- SAC, Kenya and Ghana
- Control arm: alb 400mg
- Experimental arm: alb 400mg / ivm 9mg or alb400mg/ivm18mg
- Informed consent, screening. randomization list. Ranzomization is between schools, right?
- Active surveillance from day 0 to day 2. On day 7 final visit to make sure we find out about most SAEs.
- Stool examination only for some. To test for hookworm, ascaris, t.trichiura.
- Month 11: strongyloides. we're doing serology for it.
- for the CRF: why are we not using directly tablets for it. We're using paper: it was a matter of cost on one site, the CFR is rather short. Maybe its good a idea to put it on paper and transfer it to the CRF.
- 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.