First study subject approval package

Will include:--- Templates of the Informed Consent Document (in language and terms intelligible to the participants), and details on how the consent of the legal representatives (and assent, when applicable) will be acquired-- Approvals required for invitation / enrolment of first subject in at least one clinical centre: ethics committees, national competent authorities and copies of opinion or confirmation by the competent Institutional Data Protection Officer (DPO) and/or authorization or notification by the National Data Protection Authority-- Registration number of clinical study in a WHO- or ICMJE- approved registry that also allows later posting of study results:-- Final version of study protocol as approved by first regulator / ethics committee(s), including: The procedures to be adopted to ensure the sensitive management of the participation of vulnerable individuals must be described and submitted as a deliverable; Details on incidental findings policy; The measures that will be adopted, at the end of the trial, with regard to the individuals to whom the placebo has not been administered.-- A document enclosing details on the type of cells and tissues from biobanks used in the project, as well as biobanks details (including but not limited to access restrictions). A paragraph has been added to section 5.1.4 Human Cells and TissuesM12