Brain Involvement iN Dystrophinopathies

Deliverables

Documents, reports (5)

First study approvals package

First study subject approvals package (prior to enrolment of first study subject). (i) Final version of study protocol as submitted to regulators/ethics committee(s), (ii) Registration number of clinical study in a WHO-or ICMJE- approved registry (with the possibility to post results), (iii) Approvals (ethics committees and national competent authority if applicable) required for invitation/enrolment of first subject in at least one clinical centre.

Communication, Dissemination and Exploitation plan (first release)

First release of the Communication, Dissemination and Exploitation Plan.

First study subject approvals package

First study subject approvals package' (prior to enrolment of first study subject). (i) Final version of study protocol as submitted to regulators/ethics committee(s), (ii) Registration number of clinical study in a WHO-or ICMJE- approved registry (with the possibility to post results), (iii) Approvals (ethics committees and national competent authority if applicable) required for invitation/enrolment of first subject in at least one clinical centre.

Protocol optimisation

Optimization of the neurocognitive and neurobehavioural protocols to be used in the study

Communication, Dissemination and Exploitation plan (second release)

Second release of the Communication, Dissemination and Exploitation Plan.

Websites, patent fillings, videos etc. (1)

Project Website

The project website will be formally delivered in month 4, carrying general information about BIND and the planned public deliverables; it will then be updated at regular intervals, to report on activities, events, major achievements and to provide access to public deliverables.