Organizational Institution / No of items / Qualification of staff TV-ÖD Total (€) Segment Participant / Kind of equipment / TV-L Trial Site Explanation TV-Ä Total months 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. preparation/ post-processing) Monitoring mean travel time per visit monitoring costs per day total no of days @ x € each 6 Safety / 7 Trial Committees no. of DSMB members no. of meetings / p @ x € 8 Meetings / no. of attendees no. of meetings / p @ x € travel costs monitoring Travel 9 Case Payment Assays / examinations per patient hours of staff per patient x no of patients €/patient 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 resources for open access publications only 17 Other TOTAL € months = staff inidicated in months where applicable; = other expenditures indicated in Euro where applicable; / p = per person €
Organizational Segment Institution / Participant / Trial Site No of items / Kind of equipment / Explanation Qualification of staff TV-ÖD TV-L TV-Ä Total months Total (€) 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/ post-processing) mean travel time per visit monitoring costs per day total no of days @ x € each 6 Safety / 7 Trial Committees no. of DSMB members no. of meetings @ x € / p 8 Meetings / Travel no. of attendees 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 resources for open access publications only 17 Other TOTAL € months = staff inidicated in months where applicable; € = other expenditures indicated in Euro where applicable; / p = per person
EXPLORATORY_CLINICAL_TRIAL_FULL_APPLICATION_2018.docx