Verfahren. Formale Vorgaben

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1 Leitfaden für die Erstellung von Projektskizzen im Rahmen der Fördermaßnahme des Bundesministeriums für Bildung und Forschung (BMBF) Förderung des Strukturaufbaus in der Versorgungsforschung (Modul 1) Dieser Leitfaden stellt einen erläuternden Text zu den Richtlinien zur Förderung des Strukturaufbaus in der Versorgungsforschung dar. Er dient als Hilfestellung zur Gestaltung einer beurteilungsfähigen Projektskizze und soll offene Fragen im Vorfeld der Einreichung klären. Projektskizzen, die den Vorgaben der Förderrichtlinien und des folgenden Leitfadens nicht entsprechen, können ohne weitere Prüfung zurückgewiesen werden. Verfahren In dieser Fördermaßnahme sind zwei fachliche Begutachtungsschritte vorgesehen. Die nach diesem Leitfaden erstellten Projektskizzen werden unter Hinzuziehung eines unabhängigen Expertenkreises begutachtet (Punkt der Förderrichtlinien). Im Fall eines positiven Votums zur weiteren Ausarbeitung des Antrages erfolgt die Aufforderung zur Erstellung einer ausführlichen Vorhabenbeschreibung, welche in einem zweiten fachlichen Begutachtungsschritt wiederum unter Hinzuziehung eines unabhängigen Expertenkreises geprüft wird (Punkt der Förderrichtlinien). Erst im Fall einer Empfehlung zur Förderung ist der vollständige Formantrag vorzulegen. Formale Vorgaben Eine vollständige Projektskizze muss folgende Teile umfassen: 1. das ausgefüllte und verbindlich eingereichte Internet-Formular (Projektübersicht) und eine strukturierte Projektskizze als eine Datei (pdf -Format). 2. die unterschriebene Papierform der vorher online eingereichten Projektübersicht und Projektskizze samt Anlagen in 4-facher Ausführung (davon bitte ein Exemplar ohne Bindung). Diese Unterlagen müssen identisch mit der elektronisch eingereichten Version sein. Unter steht Ihnen die elektronische Antragserfassung pt(outline* zur Verfügung. Bitte folgen Sie den Anweisungen des Programms während der Registrierung als Nutzer, des Ausfüllens des Online-Formulars und der verbindlichen Einreichung der Projektskizze. Die Eingaben für das Internet-Formular (Projektübersicht) und die verbindliche Einreichung der Projektskizzen müssen bis spätestens zum 15. Mai 2015 erfolgt sein. Entscheidend für die Fristwahrung ist die auf elektronischem Wege im Internet-Portal verbindlich eingereichte Projektskizze. Zusendungen per oder Fax werden nicht berücksichtigt. Die Antragsunterlagen in Papierform sollen bis zum 27. Mai 2015 bei dem Projektträger vorliegen.

2 Die Projektskizze ist in englischer Sprache abzufassen, der Umfang sollte 25 Seiten für Modul 1 (DIN A 4-Format, Schriftgröße 11, 1,5zeilig, keine Spiralbindung) zzgl. Anhang nicht überschreiten. Die Projektskizze soll alle Informationen beinhalten, die für ein sachgerechtes Urteil hinsichtlich der wissenschaftlichen und konzeptionellen Planung des Kooperationsnetzwerkes erforderlich sind. Sie muss aus sich heraus, ohne Lektüre der zitierten Literatur, verständlich sein und eine Beurteilung ohne weitere Informationen/Recherche zulassen. Das Vorhaben soll in knapper, aussagekräftiger Form beschrieben werden. Die nachfolgende Gliederung ist verbindlich. Erläuternde Hinweise sind bei dem jeweiligen Gliederungspunkt zu finden. Nicht zutreffende Felder können entsprechend mit n.a. gekennzeichnet werden, eine kurze Begründung hierfür ist einzutragen. Projektskizzen in Papierform sind einzureichen beim: Projektträger im DLR Gesundheitsforschung z.hd. Dr. Stefanie Gehring Kennwort Kooperationsnetzwerke Versorgungsforschung Heinrich-Konen-Straße Bonn Tel: Fax: Gliederungsschema für eine Projektskizze zur Beantragung eines Kooperationsnetzwerkes für Versorgungsforschung Alle Informationen zur inhaltlichen Ausrichtung der Förderung, den Voraussetzungen für eine Förderung sowie den Kriterien der Begutachtung finden sich in den Richtlinien zur Förderung des Strukturaufbaus in der Versorgungforschung. Im Folgenden wird ergänzend die Gliederung der Projektskizze erläutert. Die Projektskizzen für Modul 1 (Kooperationsnetzwerk) umfassen drei Teile. Im den ersten beiden Teilen A und B wird die Struktur des Kooperationsnetzwerkes dargelegt und begründet. In dem dritten Teil C sind Forschungsprojekte, die das Kooperationsnetzwerk gemeinsam durchführt, jeweils einzeln aufzuführen. Hinsichtlich der Darstellung des Kooperationsnetzwerkes ist es wichtig, dass der Beitrag zur Realisierung der strategischen Ziele der Fördermaßnahme konkret beschrieben und damit für einen Expertenkreis beurteilbar ist. Die folgende Gliederung enthält kursive Textpassagen zur Erläuterung der jeweiligen Kapitel. Die Texte zu den Aufzählungszeichen sollen Hinweise auf die Art der geforderten Informationen geben. Hierbei sind vielfach Beispiele aufgeführt, die als Hilfestellung für die Antragstellung gedacht sind. Keinesfalls wird erwartet, dass alle Beispielmodule in ein Kooperationsnetzwerk integriert werden. Zur Beurteilung soll der Projektskizze bereits ein Finanzierungskonzept zugrunde liegen, aus dem klar das Ausmaß des Engagements der beteiligten Einrichtung in der Versorgungsforschung hervorgeht. Im Hinblick auf die Konzeption der Projekte werden die durch nationale und internationale Standards gegebenen Maßstäbe guter wissenschaftlicher Praxis zugrunde gelegt.

3 Module 1: Cooperation network (Kooperationsnetzwerk) structural part Please prepare your application according to the guidelines outlined below. Explanatory notes are specified for each respective item. They should not appear in the application. Outline for research structures in health care research (Module 1) Synopsis Applicant / Coordinating investigator Health care research institution (Location of coordinating unit) Name, address, telephone, fax, In case of multiple applicants the coordinating investigator should be listed first. Correspondence will only go to this address. Institution / department Head of the institution / department (name, employment status, telephone, ) postal address Title of the cooperation network Acronym Aims of the project Thematic focus Cooperative partners Funding applied for (3 years) Not exceeding 140 characters Short Network title Explanation of main aims of the project, especially with respect to - structural and - scientific aims Explanation of thematic focus, conditions and developmental objectives from the cooperation network Enumeration of collaboration partners Total amount of funding applied for including lump sum/overhead costs if applicable A. Integrated overall concept of the network (Kooperationsnetzwerk) Please indicate in detail the aims of the cooperation network. It has to be clearly stated which requirements are met, and which concrete steps are necessary to achieve the goals (how and in which chronological order). The concept should contain a clear development towards a sustainable cooperation network after BMBF funding. 1. Summary Short and precise description of the concept for the cooperation network. Description of structure and content objectives, especially with regard to health care research at the site (not exceeding one page).

4 2. Organisational and management structure of the network (Kooperationsnetzwerk) A coordinating unit has to be installed. The unit is in charge of the structural and conceptual implementation of the aims. In addition, it contributes to the scientific and methodological development. Describe the mission of the coordinating unit. Indicate where the coordinating unit will be established and the personnel required. Outline the involved partners, including their function within the cooperation network. Indicate who will manage the network and how the decision making process will take place. Please use an organisational chart for clarification. Please state how collaboration partners from research and health care respectively will be involved in the network (e.g. core facilities, integration / association of certain research groups, collaborative efforts). Which motivation do they have for a substantial collaboration? Please comment on public relations. Especially state how visibility of the cooperation network will be promoted regarding the active approach of external partners and stakeholders. Description of responsibilities of the coordinating unit. Please focus on the coordination of research projects, interconnectedness, methodological development and sustainable visibility of the network. 3. Description of thematic focus, requirements and developmental aims of the cooperation network Description of long-term scientific research aims taking the required structural changes into account. Please explain briefly the research landscape of the chosen area. Indicate the position of the cooperation network within this area and comment on its specific innovative contribution. Please comment on the sustainability of the cooperation network. Indicate how sustainability will be achieved, especially in the long-term view. 4. Junior research and career development Overview of existing and planned concepts with regard to promotion of young scientists within the cooperation network. Describe actions for each step of scientific training and development of personnel, and comment on contribution of these actions to the cooperation network.

5 4.1. Promotion and integration of young scientists During which stages of education, training and promotion of scientists are topics related to health care services addressed? (e.g. study program, compulsory subject, Phd programs, collaborations, ). Comment on the recruitment of young research scientists. Are there any systematic approaches established? Are there any qualification- and mentoring programs for Phd students established? Comment on possibilities to support and promote young scientists within the planned network. How do and will they in future support health care research in Germany? Comment on the added value regarding career opportunities for young research scientists in health care research, national and international Optional module Junior research groups in health care research Network partners with established health care research and education are encouraged to give young scientists the opportunity to establish a junior research group. Skilled young scientists ought to have the opportunity to qualify themselves for a research career by independently conducting a research project and take responsibilities for staff members. Support is given by funding of defined research projects (see Leitfaden für die Erstellung von Projektskizzen im Förderschwerpunkt Förderung des Strukturaufbaus in der Versorgungsforschung (Modul 2) ). In case that a junior research group shall be installed within the network, the thematic focus addressed by the junior research group has to comply with the thematic focus of the network. Comment on the necessity and the interconnectedness of the junior research group within the cooperation network. If applicable state here We submit an application for a junior research group in health care research in this call and give the title and number of the application. 5. Work plan Describe the intended working operations and time frame for establishing the cooperation network (Gantt-Chart). Milestones indicating the working progress have to be defined (include in Gantt-Chart).

6 B. Structural and scientific situation 1. Scientific and structural contribution of participating institutions Overview of research priorities in health care research of the institution(s). According to the research profile, describe the structural and scientific contributions onsite. Short description of characteristic key research areas for the cooperation network indicating the respective institution. Please use the table below for an overview. Research Institution Professorship or Third party funding area working group (amount and source) (associated with research area) e.g , DFG Indicate existing strategies for profile building. Short description of other available internal programmes at the faculty and clinic for research support (aim, extent, selection and procurement procedures). 2. Description of existing collaborative structures Do use the table below for explaining the already established collaborative structures. The following descriptions have to be included in the table: Description of existing collaborations between research partners: Short report of the profile from each research partner (please annotate 5 significant publications and activities) including occasion and profile of the collaboration (please state if the collaboration is occasionally, permanent, contract governed). Description of existing collaborations with health care institutions interested in research (e.g. nursing homes, care practices) or self-help organizations and patient advocacy groups: Short profile of involved partners including a description of type and content of collaboration. Description of existing collaborations between data owner of routine data sets (e.g. health insurance companies, public entities): Provide a short profile from each partner including a description of type and content of the collaboration.

7 Description of existing international collaborations: Please outline type and extent of existing international research connections, collaborations in international scientific working groups, committees and specialized societies. Type of collaboration Scientific collaboration partners Partners from the health care institutions Aim of collaboration e.g. Promotion of young scientists Scientific projects e.g. studies with partner XY concerning Unit, address, Head institution Research profile / participation in research Specific contribution as collaboration partner of the network Self Help Groups / Patient Organisations Provider of routine data International collaborations Consulting, transfer Secondary data analysis regarding Corporate project in the field of C. Research aims and projects 1. Overview of planned scientific research projects within the cooperation network Please give a brief overview of the scientific research projects: How do they contribute to the long-term goals? Describe briefly the interconnectedness of the research projects within the cooperation network. 2. Description of research projects Research projects need to contribute to the overall thematic focus and concept of the cooperation network. Please give a short description for each of the planned research projects of the cooperation network, not exceeding 4 pages for each project.

8 2.1. Summary of research project Applicant Title Aims of the project Thematic focus Methods Name, address, telephone, fax, In case of multiple applicants the coordinating investigator should be listed first. Not exceeding 140 characters. Acronym is optional. Explanation of the main aims of the project, especially with respect to the structural and scientific aims of the network. Short description of thematic focus Description of methodological approaches (data collection, statistical analysis ) Collaboration partners Funding applied for (3 years) Enumeration of needed collaboration partners and their tasks (e.g. recruitment, allocation of data / methods.) Total amount of funding applied for including lump sum/overhead costs, if applicable Scientific research aims and evidence from international research Thematic focus of the research project with specific emphasis on supporting the cooperation network Please justify the added value of the research project for the overall concept of the cooperation network. Evidence / Current state of research Set your study into perspective. Which studies have been conducted either by you or by others? What is the relevance of their results? If you believe that no relevant previous studies have been performed, give details of your research strategy for existing information. This should both detail the background of the major research question and the feasibility of the study. Aims and theoretical framework Which principal research questions are addressed? What is the novel aspect of the proposed study? Indicate the theoretical framework / the detailed concept the study is built on. Epidemiological and economical relevance What impact will the results have on health care? Why is the study needed now? How often does the problem which is addressed by the study occur? How will the individual patient as well as the health care system benefit from the study?

9 Design and research methods Give an overview of the chosen design you want to apply to answer the research question. Justify the population to be studied, the proposed sample size, the sampling strategy and the decisive factors / criteria for defining the sampling. Describe and justify your field access, including details how to overcome access barriers. Work plan Describe the intended working operations and time frame according to individual worksteps (Gantt Chart). Milestones indicating the progress of the work have to be defined Dissemination and implementation Beyond regular research publication, please outline intended measures to disseminate and implement the results within the health care system (e.g. patient information, information for health care providers, changing of health care practise) and the actors involved (e.g. sickness funds, professional societies, general practitioners). An active role of the cooperation network and its partners is expected. Statement on sustainability of the cooperation network after BMBF funding (see Attachments III.3). 3. Financial plan Total costs for the cooperation network have to be assigned in the table below. Costs for basic equipment as well as service deliveries are not applicable for funding. Applied funds have to be justified according to the work plan. Position Coordinating centre* Research project 1 Research project 2, Year 1 3 (sum) Personnel (Person Months) Scientific Non-scientific Other Subcontracts Consumables Equipment Travel costs Overhead / lump sum Total amount

10 4. Other funding In case you have already submitted the same request for financial support or parts hereof to other institutions, please mention this here. Indicate those parties which will provide funds, free services, or consumables such as drugs or medical products. If this is not the case please declare: A request for funding this project has not been submitted to any other addressee. In case I submit such a request, I will inform the Federal Ministry of Education and Research immediately.

11 III: Attachments Please prepare your application for module 1 with the following documents: 1 References Please list publications you have quoted within your application. References should be listed according to their numerical appearance in the text. 2 Third party funding Please list third party funding for the last 5 years of the institution or faculty with relevance for health care research. 3 Sustainability Statement of the faculty regarding sustainability of the funding measure after BMBF funding. An appropriate signed letter of intent (LOI) has to be provided with this application. 4 Curriculum vitae Include tabular scientific CVs (not exceeding 1 page per person) for academic staff members playing a leading role (e.g. applicant and co-applicants, junior research group leader, study statistician, not all collaborating partners at all trial sites). 5 Declaration of commitments 5.1 Declaration of commitment of participating centres Participating/recruiting centres must declare their commitment on a separate sheet including their signatures (if an umbrella organisation or a network of several recruiting centres is involved, it is sufficient when the authorised representative of the organisation or the network, signs the sheet) and giving the following details, if applicable: a) Name of investigator b) Institution c) Trial name d) Trial duration e) Inclusion/exclusion criteria f) Strategy for the determination of recruitment figures at the recruiting centre g) Number of patients expected to be recruited for the trial under the above mentioned criteria h) Detailed description of the working package conducted by each/the participating centre(s) i) Conflict of interest j) Signature

12 5.2 Declaration of commitment of sickness funds or other institutions providing data (e.g. German Pension Fund) If data from sickness funds or other institutions are used for the study, the access to data needs to be clarified and documented. a) Contact person b) Institution c) Study name d) Data provided (inclusion/ exclusion criteria, number of patients) e) Data protection f) Conflict of interest g) Signature