Final project Report and SCOPE recommendation for clinical guidelines available for the public.
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.
The report on the statistical analysis of biomarkers will inform the scientific community on the possibilities to implement innovative kidney biomarkers panel in clinical practice.
The Cohort study report will include all relevant aspects of the field work. It will describe major strenghts of the SCOPE and Scope+ Iohexol cohorts and its eventual limitations.
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.
The report will assess the cost-effectiveness of the innovative screening programmes for CKD in the older population using the data from the SCOPE cohort.
At month 55 status of dissemination and communication activities will be collected from all partners and measured against Key performance indicators. Conclusions on the implemented actions will be reported and best practice. Exploitation actions implemented by partners will be reported . Appropriate confidentiality issues will be reported in line with CA.
The Case Report Form (CRF), designed specifically for the project, will be evaluated for consistency with the protocol, finalized for implementation in the electronic form (e-CRF), accessible to all project partners.
Educational toolkit for medical students will be available in the languages of the SCOPE partners (English, German, Italian, Spanish, Polish, Swedish, Dutch, Hebrew) plus French.
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Author(s): A.C. Carlsson, C.J. Östgren, T. Länne, A. Larsson, F.H. Nystrom, J. Ärnlöv
Published in: Diabetes & Metabolism, Issue 42/5, 2016, Page(s) 351-357, 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