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.
The 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 program
Intermediate 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 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.
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Author(s): Lorna Leal, Csaba Fehér, Valèria Richart, Berta Torres, Felipe García
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Author(s): Beatriz Perdiguero; Suresh C. Raman; Cristina Sánchez-Corzo; Carlos Oscar S. Sorzano; José Ramón Valverde; Mariano Esteban; Carmen Elena Gómez
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