Page 35 - eBook Version 8 Book 1 of 2 JUL 2022

2. What is the maximum age you intend to enroll? . o many adult atients do you intend to enroll?
. oes study re ruitment o adult arti i ants re uire in lusion o ne atients at hildren s i.e. a atient
o ulation not re iously treated at hildren s?
lease ex lain

. s the study more than a minimal health ris to a study arti i ant e.g. inter entional ro edure ex erimental
thera y et .?
lease ex lain

. oes the study re uire uni ue lini al ex ertise a aila le at hildren s that is not a aila le in other lo al health are a ilities su h as W ar land other?

lease ex lain
. Who ill are or the atient in the e ent o a medi al emergen y and or hat adult resour es might e re uired?
lease ex lain
. oes the study re uire uni ue e ui ment so t are and or a ilities a aila le at hildren s that are not a aila le at other lo al health are a ilities su h as W ar land other?

lease ex lain
. o ill hildren s re ei e reim ursement or the resear h related ser i es or the adult atients enrolled in
ther esear h study?
lease ex lain

. o ill the resear h ene it the health o hildren e.g. the element o li es an are resear h ?
lease ex lain
Version Date 7/16/2021
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