EU-Hochschulbüro der Universitätsmedizin Göttingen Geschäftsbereich für Internationale Beziehungen

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1 Geschäftsbereich für Internationale Beziehungen Antragsberatung: früher Zugang zu gezielten Informationen, persönliche Beratungsgespräche, Kontaktherstellung zu möglichen Partnern und Koordinatoren, Antragsworkshops Begleitung der Antragstellung: Für ERC und Koordinationsprojekte: Organisation und Ausrichtung von Preparatory Meetings, Erstellung von Textabschnitten zu Management und Dissemination, Beratung zum Ethik-Teil, Budget-Kalkulation und Erstellung aller administrativen Unterlagen; Registrierung im Participant Portal, ECAS ACCOUNT Für Partnerprojekte: Budget-Kalkulation, Ausfüllen der administrativen Unterlagen Begleitung der Vertragsverhandlungen; LEAR; L-sign; F-sign; Durchführung des administrativen Projektmanagements inklusive Reporting und Audits; Kommunikation mit der EU; REA

2 Arbeitsgruppe zu Clinical Trials Kurze Historie: Clinical Trials Workshop in Brüssel Herbst 2013 initiiert: Im Hinblick auf Abrechnungsmodalitäten in FP7 zu Clinical Trial OTHER versus RTD zu Regulatory Affairs Und Ausblick H2020 Clinical Trials Abrechnungsmodalitäten/Unit Costs Akteurinnen: Medizinische Hochschule Hannover: Dr. Simone Heß/ Dr. Katrin Dinkla-Ritter Charité Berlin: Eveline Fräsdorf Universitätsmedizin Göttingen: Christiane Hennecke

3 Clinical trials FP7/H2020 FP7 versus H2020 Was bleibt was hat sich verändert? FP7: Amendments zu Regulatory Affairs überwiegend abrechenbar in OTHER (100% Erstattung) Audit Notes formuliert zu auditierbaren Patient Fees H2020 : Still under discussion UNIT COSTS

4 H2020 : Still under discussion UNIT COSTS Was ist derzeit als problematisch anzusehen/was wurde erreicht: - Verwendung historischer Daten als Kalkulationsgrundlage versus Increase der Kosten über die Laufzeit des Projektes - Verfügbarkeit des Studienprotokolls spätestens zu Projektbeginn zur Kostenkalkulation - Grundlage für die Kostenkalkulation DKGNT/GÖÄ - Unit Costs pro Projekt bindend, nicht für alle Projekte für eine Institution - Jeder Projektpartner darf seine Unit Costs kalkulieren - Unit Costs bedeuten nicht entweder oder sondern sowohl actual costs und Unit Costs als Kosten des Trials erlaubt

5 Purpose / Scope Based on Commission Decision C(2014) Unit costs are: a fixed reimbursement amount for each study subject enrolled in a given centre calculated according to a defined methodology based on historical costs of the beneficiary/third party for the entire funding period of an action. [NOT a flexible tool, adjustments during the time course of an action are not possible.]

6 Legal Base/Purpose Based on Commission Decision C(2014) Ex-ante acceptance of unit costs = No need for time sheets and detailed tracking of resources used! Unit costs should encourage consortia to more realistically estimate their budget and time management for clinical studies. Unit costs are a simple and transparent method for calculating, reimbursing and auditing costs of clinical studies.

7 Scope Unit costs can be used in any action under SC 1 Unit costs can be used by: beneficiaries linked third parties [Art. 14] third parties contributing in kind to the clinical study [Art. 11] Unit costs can be used for any type of clinical study.

8 Conditions I Alternative to the use of actual costs, on voluntary basis. Resources and costs will be evaluated with the proposal. Unit costs per patient/study subject fixed for the entire duration of the project. For costs not included in the unit cost, reimbursement based on actual cost.

9 Conditions II Per clinical study subject: Estimation of the resources per task on the basis of the protocol, the same for all beneficiaries involved. Per beneficiary/third party: Calculation of costs based on its historical costs: recorded in its certified or auditable profit and loss accounts, for last closed financial year at the time of submission of the proposal. Verification and audit ex-post only: number of patients/subjects declared = number of patients/subjects actually participating in the study Beneficiary/third party has used the accounting data of year

10 Conditions III Direct costs of clinical studies (defined categories, no other categories possible!) Personnel (doctors, other medical, technical personnel) Consumables Medical equipment (depreciation and costs of service contracts necessary for their functioning) Other specific service contracts necessary for the clinical study Indirect costs of the clinical study (25% of direct costs) Excluded from unit costs, e.g.: Travel and subsistence costs of patients/subjects are not included (reimbursed on the basis of eligible costs actually incurred under the cost category other direct costs )

11 Unit cost component personnel costs (1) 3 unique and exclusive (!) personnel categories: Doctors Other medical personal Technical personnel No other personal category / calculation base for personal costs possible (e.g. categories for nurses 'study nurses' or 'pharmacists' do not exist!)

12 Unit cost component personnel costs (1) 3 unique and exclusive (!) personnel categories: Doctors Other medical personal Technical personnel No other personal category / calculation base for personal costs possible (e.g. categories for nurses 'study nurses' or 'pharmacists' do not exist!)

13 H2020 Clinical trials Weitere Informationen Präsentation im Nachgang zum Infoday im September

14 H2020 Clinical trials Problemstellung Clinical Trials project extensions patient recruitment Please note: Extension of project duration can generally not be granted in H2020. Significantly delayed key study milestones (e.g. 'first patient/first visit') might lead to the termination of the grant agreement.

15 Herzlichen Dank für Ihre Aufmerksamkeit! Christiane Hennecke Kontakt: