10.3 FINANCIAL PLAN Total ressources required Con- Staff sumables Organizational No. segment/ Explanation/ Comments/ Items activity/ task salary €2) €2) group Months1) 1 Clinical Project Management 2 Project Management 3 Data Management 4 Biometry 5 Quality number of visits per site (incl. pre-study, initiation, interim and close-out visits) Assurance/ mean number of days per visit (incl. Monitoring preparation/ postprocessing) mean travel time per visit monitoring costs per day total no of days @ x each € 6 Safety / 7 Trial no. of meetings @ x / p € Committees 8 Meetings / no. of meetings @ x / p € travel costs monitoring Travel 9 Case Payment assays/examinations per patient hours of staff per patient / patient x no of patients € 10 Reference no. of samples@ x € Centers 11 Materials Consumables, trial manuals, files, forms 12 Trial Drug / patient € 13 Insurance / patient € 14 Fees 15 Equipment > 410 € 16 Publications Please note that only resources for open access publications will be granted 17 Other TOTAL TOTAL RESOURCES APPLIED FOR 10.4 Equipment 10.5 Co-financing by industry and / or other third parties 10.6 Other funding
10.3 FINANCIAL PLAN No. Organizational segment/ activity/ task Explanation/ Comments/ Items Total ressources required Staff Con- sumables salary group Months1) €2) €2) 1 Clinical Project Management 2 Project Management 3 Data Management 4 Biometry 5 Quality Assurance/ Monitoring number of visits per site (incl. pre-study, initiation, interim and close-out visits) mean number of days per visit (incl. preparation/ postprocessing) mean travel time per visit monitoring costs per day total no of days @ x € each 6 Safety / 7 Trial Committees no. of meetings @ x € / p 8 Meetings / Travel no. of meetings @ x € / p travel costs monitoring 9 Case Payment assays/examinations per patient hours of staff per patient € / patient x no of patients 10 Reference Centers no. of samples@ x € 11 Materials Consumables, trial manuals, files, forms 12 Trial Drug € / patient 13 Insurance € / patient 14 Fees 15 Equipment > 410 € 16 Publications Please note that only resources for open access publications will be granted 17 Other TOTAL TOTAL RESOURCES APPLIED FOR 10.4 Equipment 10.5 Co-financing by industry and / or other third parties 10.6 Other funding
EXPLORATORY_CLINICAL_TRIAL_FULL_APPLICATION_2018.docx