Deliverables & Milestones

D1.1 Confirmation of the Composition of Organisational Structures and Committees (Month 1) (R) (CO)

D2.1 Final version of the study protocol as submitted to Institutional Animal Care and Use Committees (IACUC) (Month 3) (R) (CO)

D3.1 - First Study subject approvals package - Clinical Study Documents (Protocol; List of Variables for eCRF; Informed Consent) (Month 3); Clinical Study Procedures for examinations and eCRF (Month 6); Copies of ethical approvals for all Clinical Sites (Month 6); Confirmation document that demonstrates that the activity could be legally carried out in an EU country (Month 6).

D4.1 Study-specific Acquisition Protocols for ophthalmological and brain images (Month 4) (R) (CO)

D4.2 Provide CORC online platform for ophthalmological exams submission (Month 4) (DEC) (CO)

D5.1 Guidelines to homogenise neuropsychological test battery at all sites (Month 3) (R) (CO)

D6.1 Creation of a blood collection (Month 10) (R) (CO)

D8.2 Data Management Plan (Month 6) (R) (CO)

D9.2 Development of the logo and website (Month 3.The website will be updated continuously) (DEC) (PU)

D10.1 : H - Requirement No. 1 [6] - The procedures and criteria that will be used to identify/recruit research participants must be obtained, kept on file and copies submitted to the European Commission upon request 2. Templates of the informed consent/assent forms and information sheets (in language and terms intelligible to the participants) must be obtained, kept on file and copies submitted to the European Commission upon request.

D10.2 : HCT - Requirement No. 2 [3] - As commercially available human cells will be used, details on cell types and provider must be kept on file and copies submitted to the European Commission if requested. 2. For human cells/tissues obtained from a biobank, details on the cell/tissue types and on the biobank and access to it must be kept on file and copies submitted to the European Commission if requested.

D10.3 : POPD - Requirement No. 3 [12]- The host institution must confirm that it has appointed a Data Protection Officer (DPO) and the contact details of the DPO are made available to all data subjects involved in the research. For host institutions not required to appoint a DPO under the GDPR a detailed data protection policy for the project must be submitted as a deliverable. 2. The beneficiary must explain how all of the data they intend to process is relevant and limited to the purposes of the research project (in accordance with the ‘data minimisation ‘principle). This must be submitted as a deliverable. 3. A description of the security measures that will be implemented to prevent unauthorised access to personal data or the equipment used for processing must be submitted as a deliverable. 4. If personal data are transferred from the EU to a non-EU country or international organisation, confirmation that such transfers are in accordance with Chapter V of the General Data Protection Regulation 2016/679, must be submitted as a deliverable. 5. Detailed information on the informed consent procedures in regard to data processing must be submitted as a deliverable. 6. Templates of the informed consent forms and information sheets (in language and terms intelligible to the participants) must be must be submitted as a deliverable. 7. An explicit confirmation that the data used in the project is publicly available and can be freely used for the purposes of the project must be submitted as a deliverable. 8. In case of further processing of previously collected personal data, an explicit confirmation that the beneficiary has lawful basis for the data processing and that the appropriate technical and organisational measures are in place to safeguard the rights of the data subjects must be submitted as a deliverable.

D10.4 : A - Requirement No. 4 [6] - Copies of relevant authorisations for animal experiments (covering also the work with genetically modified animals) must be submitted as a deliverable. 2. Information on the application of the humane endpoints and humane intervention points in the study must be submitted as a deliverable.

D10.5 : EPQ - Requirement No. 6 [12] - Copies of authorisations for relevant facilities (e.g., security classification of laboratory, GMO authorisation) must be obtained, kept on file and copies submitted to the European Commission upon request.

D10.6 : H - Requirement No. 8 [12] - The informed consent procedures that will be implemented for the participation of humans must be submitted as a deliverable. 2. The applicant must clarify what measures will be taken to minimise possible pain and discomfort associated with the invasive and imaging procedures, and these must be submitted as a deliverable. 3. Copies - of opinions/approvals by ethics committees and/or competent authorities for the research with humans must be submitted as a deliverable. 4. For each clinical study, the following documents/information must be submitted as a deliverable (in one 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.

D10.7 : A - Requirement No. 9 [12] - If applicable, copies of training certificates/personal licenses of the staff involved in animal experiments must be obtained and kept on file and copies submitted to the European Commission upon request.

MS1 - Obtaining all ethical approvals