It includes the following documents, finalized according to the requirements of an international clinical study: 1) Protocol and protocol synopsis: the official final version of the study protocol (assumed a 100-page document); 2) Patient Information Sheet/Patient Informed Consent (PIS/PIC); 3) Letter to the General Practitioner; 4) Case Report Form (CRF): a Case Report Form (CRF); 5) Investigator’s Manual; 6) Translation of relevant documentation.
At month 18 data on dissemination and communication plan will be updated and the actions implemented by all partners will be collected in one report and measured vs agreed Key Performance indicators agreed at kick meeting. Strategy of exploitation will be designed as agreed at kick off meeting.
At month 36 status of dissemination and communication activities/results will be collected from all partners and measured against Key performance indicators. Ad hoc actions will be implemented if target groups/tools and dissemination messages will need to be updated. Exploitation actions will be reported. Appropriate confidentiality issues will be reported in line with CA.
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Published in: ISSN 1262-3636
Author(s): A. C. Carlsson, J. Sundstro m, J. J. Carrero, S. Gustafsson, M. Stenemo, A. Larsson, L. Lind, J. A rnlo v
Published in: European Journal of Preventive Cardiology, 2016, ISSN 2047-4873