Rezultaty
HIVACAR Phase I/IIa clinical trial protocol: A document containing the description of the clinical trial, the research brochure and all other documents requested by the MEC’s for all sites of clinical intervention.
Final report on dissemination activitiesFinal report on dissemination activities A detailed list of all dissemination activities carried out during the project with assessment of their impact and degree of compliance with the plan
Data Management PlanThe Data Management Plan will be prepared at month 12 and an updated version will be delivered at month 30.
Final Briefing Document sent to EMA to request Scientific Advice containing information on the quality, nonclinical and clinical development programFinal exploitation and sustainability plan
Final exploitation and sustainability plan This report will analyse the exploitation and sustainability models to exploit and promote the use of the HIVACAR results beyond the project life
Intermediate report on dissemination activitiesIntermediate report on dissemination activities: A detailed list of dissemination activities carried out halfway through the project, with assessment of their impact, the degree of compliance with the plan, and a description of foreseen dissemination activities until the end of the project.
Targeted communication toolsTargeted communication tools: This deliverable includes tools such as: 1) The review and adaption of the clinical trial synopsis and informative materials to be shared with the participants and the community; 2) Creation of leaflets and other informative materials informing on the project objectives and expected outcomes; 3) The creation of a communication tool (such as an online forum) where the patients enrolled in the clinical trial can raise questions regarding the trial development, share their concerns and expectations regarding their participation. The tool will also allow monitoring and prevent possible dropouts and to manage expectations regarding the outcomes of the project.
Final assessment of the projectFinal assessment of the project At the end of the project a final assessment of the degree of fulfilment of the objectives of the project including an assessment of the use cases will be carried out and reported in this deliverable For both D13 and D14 the responsible of performing the assessment of the project will be the project coordinator Dr Felipe Garca with the input and advice from both the Steering Committee and the Scientific Advisory Board
- Final version of study protocol as submitted to regulators / ethics committees- Registration number of clinical study in a WHO- or ICMJE- approved registry - Approvals (ethics committees and national competent authority) required for invitation / enrolment of first subject in at least one clinical centre
Communication planCommunication plan: This document will describe in detail the project communication strategy in all of its components: objectives, audiences, actions and tools.
Publikacje
Autorzy:
Beatriz Perdiguero, Cristina Sánchez-Corzo, Carlos Oscar S. Sorzano, Lidia Saiz, Pilar Mediavilla, Mariano Esteban, Carmen Elena Gómez
Opublikowane w:
Viruses, Numer 11(2), 2019, Strona(/y) 160, ISSN 1999-4915
Wydawca:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/v11020160
Autorzy:
Beatriz Perdiguero; Suresh C. Raman; Cristina Sánchez-Corzo; Carlos Oscar S. Sorzano; José Ramón Valverde; Mariano Esteban; Carmen Elena Gómez
Opublikowane w:
Viruses, Numer 10(8), 2018, Strona(/y) 424, ISSN 1999-4915
Wydawca:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/v10080424
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