Second conslusions of annual cluster meeting and policy brief
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Conclusions of common annual meeting of the ‘Diagnosis and treatment’ cluster including policy brief formulating recommendations based on the research and innovation strand of the ‘Diagnosis and treatment’ annual cluster meeting
Decision making model, measures and study protocol
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Overview of the model describing the process of decision-making in situations of therapeutic uncertainty (with supporting literature and development process) and protocol of the mixed-methods study to investigate it
Report of the BRCA mutation and homologous recombination status used in real-life setting
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Inventory of the assays used in the different centers for assessing the HRD status (BRCA mutation, genomic instability, other), and description of level of evidence for each assay
Submission package including clinical trial documents
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Study initiation package (before enrolment of the first study participant) including: •Registration number of the clinical study in a registry meeting WHO Registry criteria (see also references given in subheading 1.1 of this template)•Final version of study protocol as approved by the regulator(s) / ethics committee(s)•Regulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)
Statistical analysis plan
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Document describing how the data will be analysed with regard to the objectives of the study
Dissemination and communication activities from M1 to M36
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Consortium workshops, Conference workshops, Abstracts, Publications in peer-reviewed journals, Flyers, Newsletters, and presentations realized from M1 to M 36
Statistical analysis plan of HR-QoL data
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Report of the statistical analysis plan of quality of life data, with respect to the objectives of the clinical trial concerning Quality of Life issues
Projet logo, presentations template, press releases
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Logo of the SALVOVAR project. Template to be applied for all the presentations concerning SALVOVAR project, Press releases to announce SALVOVAR project
First conclusions of annual cluster meeting and policy brief
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Conclusions of common annual meeting of the ‘Diagnosis and treatment’ cluster and policy brief formulating recommendations based on the research and innovation strand of the ‘Diagnosis and treatment’ annual cluster meeting
Work plan for cluster activities
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Initial common work plan for scientific collaboration under the ‘Diagnosis and treatment’ cluster
Translated Questionnaires of Quality of Life
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Questionnaires of quality of Life translated in local languages of all participating centres
Intermediate trial conduction and safety report
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Trial conduction and safety report at the end of the inclusions
Centralized reviewing of eligibility criteria based on surgery outcome
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Operative ESGO report and mandatory field for inclusion edited
Dissemination and communication plan V1
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Release of the first dissemination and communication plan of SALVOVAR project
Mid-term Recruitment report
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This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.
Harmonized stratification criteria
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List of non-resectability criteria edited
