Programma di ricerca Regione - Università Area 1 "Ricerca Innovativa" Bando Giovani ricercatori Alessandro Liberati GUIDELINES for SUBMISSION

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1 Programma di ricerca Regione - Università Area 1 "Ricerca Innovativa" Bando Giovani ricercatori Alessandro Liberati 2013 GUIDELINES for SUBMISSION This document is intended as an aid to walk Principal Investigators (PIs) through the assembly of the Project by explaining in details how to appropriately fill in the Application Forms. Introduction Triage All Proposals received within the Deadline (June 7 th 2013, 12pm noon -) as published in the Call, will be checked by the Segreteria Scientifico-organizzativa Programma di Ricerca Regione-Università against the presence of eligibility criteria. Validity of the requested Declarations: 1. PI Declaration of not having received any grant from the Emilia-Romagna Region in the past 3 (three) years; 2. Declaration that the submitted research Proposal has never been funded before by the Emilia-Romagna Region and/or by the Italian Ministry of Health; 3. PI Declaration of co-funding, if applicable; 4. Declaration of support and certification from the Hosting Institution; 5. Relevance of the submitted Proposal with the foreseen Thematic Areas; 6. Proposal completion and compliance with the specific Call requirements; 7. Proposal final submission within the deadline. All the Forms have to be personalized by appropriately filling in the mandatory fields (ie those marked with an asterisk * ).

2 Proposals are submitted by the Principal Investigator who is responsible for the Project as well as for all implicit declarations. Proposals must fulfil all eligibility criteria if they are to be retained for peer-review evaluation. PI whose Proposal will be deemed not eligible for peer-review evaluation can appeal to the Comitato di Indirizzo del Programma di ricerca Regione-Università for a re-examination of the reasons behind such exclusion. Any decision taken by the Comitato di Indirizzo with regard to the exclusion of any Proposal from the specifc Call is unappealable. The peer-review process Two to three Reviewers (i.e. independent Experts), operating outside the boundaries of the Emilia-Romagna Region, will remotely perform individual assessments and marking of Proposals, basing on the following criteria: scientific soundness of the Proposal, Proposal transferability and impact on the Regional Healthcare Service, feasibility of the Proposal in the given timeframe, and in compliance with the resources available and the proposed budget. The name of the enrolled independent Experts will not be made public until completion of the review process. Any direct or indirect contact about the peer review evaluation of this specific Call between the PI (or the PI hosting Institution) and any independent Expert involved in the relevant peer review evaluation is strictly forbidden. Any such contact may result in the decision of the Emilia-Romagna Region to exclude the Proposal concerned from the Call in question. Based on the outcome of the peer-review evaluation, a rank order list (ROL) of Proposals for possible funding will be prepared by the Segreteria scientifico-organizzativa Programma di Ricerca Regione- Università, establishing the priority for funding within the limits of the budget available for the Call. The ROL will be validate by the Comitato di Indirizzo Programma di Ricerca Regione-Università, which will supervise the entire process. Language Please note that the working language of the submission and peer review evaluation is English. An effort should be done in writing the Proposal in the most clear and effective way in order to facilitate the overall reviewing process. Forms Applicants are asked to download, fill in and submit 3 (three) Forms: Form A. Identification of the applicant and other participants (mandatory)

3 Form B. Project description (mandatory) Form C. Suggested Reviewers (optional) Forms A and B can be downloaded together. Form A. Identification of the applicant and other participants A1. Principal Investigator Name, Surname, Date of Birth, working Address (relevant hosting Institution/Organization, Dept., Address - Street, N.; Postal Code; City; State), Phone number and address must be provided. A2. Affiliation One of the following options must be indicated: AO-U di Bologna, AO-U di Modena, AO-U di Parma, AO-U di Ferrara, IRCCS Istituto Ortopedico Rizzoli di Bologna, IRCCS Istituto delle Scienze Neurologiche di Bologna. A3. Type of Research Mutually exclusive choices are: Biomedical research (theory enhancing) or Clinical research (change promoting), as defined in the Call. A4. Thematic Area The submitted Project should fit in one of the following Thematic Areas: Advanced Diagnostics; Cardiovascular; Neuroscience; Oncology; Rehabilitation; Regenerative medicine and Transplantation; Viral and autoimmune pathologies. A5. Title (200 characters, spaces included) should be as short and clear as possible to precisely identify the context, type and general aim of the Project. The Running Title (50 characters, spaces included) should allow catching the core of the Project at a glance. Up to 3 most relevant Keywords are allowed to better describe the overall Project: at least one keyword should be indicated.

4 A6. Research Units A brief description of the participating Research Units should be provided. Collaborations with Organizations / Institutions / Departments located outside the Emilia-Romagna Region cannot be included in the Research Units list. Should the number of Research Units be larger than 6 (six), please contact the helpdesk (wfemiliaromagna@cbim.it - Phone: (Monday - Friday 9:00-18:00). A7. Budget This grant can cover up to 100% of the total eligible direct costs of the research plus a contribution towards indirect costs. All items in the following tables have to be filled in, with a few exceptions. A7.1 Provisional Cost of the Project (in Euros): full estimation of the total Project cost. This field is the automatic sum of Co-Funding and Total Budget (A7.7): you do not need to fill this in. A7.2 Co-Funding: to be filled in only if applicable, i.e. in case the PI and/or the hosting Institution have been granted other funds to carry out the Project to be submitted. A7.3 Requested Funding: is the amount of money requested to cover, either totally or partially (in case of a co-funding), the provisional cost of the Project. This field is automatically filled in. A7.4 List of Personnel. Only personnel specifically enrolled for participating to the Project have to be reported here. The duration of the contract of employment cannot exceed the foreseen duration of the Project. For each personnel to be enrolled please specify: i) progressive number of the Research Unit as previously reported; ii) Title (Degree) and position (brief job description); iii) contract of employment (examples of this kind are given in the relevant footnote); iv) area of expertise & role (for the latter, please refer to the relevant footnote keeping into account that choices are not mutually exclusive); v) months per person: total time of estimated participation to the Project, as per contract of employment, expressed in months; vi) Full time equivalent: ratio of total number of (to be) paid hours during a period (part-time, fulltime, other) by the number of working hours in that period, usually considered Monday to Friday. Administrative personnel can be included, yet should be considered as part-time personnel; vii) the salary foreseen for the entire duration of the Project. A7.5 Equipment and Disposable: furniture, telephones (including mobiles), fax, and similar items cannot be included. A7.6 Services: services from institutions located outside the Emilia-Romagna Region are considered outsourcing. A7.7 Summary of Budget breakdown: costs previously reported have to be broken down into yearly costs. A8. Administrative Coordinator: Contact Details: Name & Surname; Affiliation (hosting Institution / Organization); Address (Street, N.; Postal Code; City; State); Phone number; address. Should the PI play the role of both scientific and administrative coordinator, only the Name & Surname fields have to be filled in.

5 A9. Resubmission: if the Project has been previously submitted to the Giovani Ricercatori Alessandro Liberati 2012 call or to the Ricerca Finalizzata del Ministero della Salute it has to be indicated here along with the relevant title, if different from the current one. A10. If the Project foresees the use of Stem Cells, Animal models, Biological samples, Human subjects, Registered or unregistered Drugs, Medical devices, it should be reported here. Form B. Project Description Description of scientific and technical aspects of the Project, demonstrating the ground-breaking nature of the research, its potential impact, and research methodology. B1. Summary (max 2,000 characters, spaces included): brief description of the Project broken down into: Background; Objectives; Methods; Expected Results. The summary should, at a glance, provide the reader with a clear understanding of the objectives of the Proposal, how they will be achieved, and their relevance to the Proposal. B1.2 List of Acronyms: Acronyms should be explicitly clarified the first time they are used, even when widely recognized (eg Glasgow Coma Score, hereafter GCS ). In case the text contains more than one acronym, it is mandatory to add a list of acronyms displayed in alphabetical order. B2. Description B2.1 Background and Rationale (max 3,500 characters spaces included): briefly summarize the up-to-date (international) knowledge on the research topic, including at least three relevant references, possibly in the form of Reviews / Systematic Reviews, the newly expected generated knowledge and how it is expected to address regional and/or context-specific clinical unmet needs in the medical realm. B2.1.1 Bibliography. References formatting: when citing articles with up to 6 authors, all authors should be listed; for articles with more than 6 authors, the name of the first 6 authors should be listed instead, followed by et al. The suggested format is: Authors (Surname, Initials); title. Journal, year of publication; Volume: pages. Articles in press, or submitted and accepted for publication, may be listed among the references, provided a journal name and the DOI (or a tentative year of publication) can be verified. B2.2 Preliminary data (max 2,500 characters, spaces included): any compelling evidence obtained by the proponent, previously to submission of the Project, should be reported here. Figures must be uploaded separately and should be submitted in b/w, avoiding grey shades and/or colours as much as possible. B2.3 Detailed description of Specific Aims / Preliminary and Secondary Objectives (max 4,000 characters, spaces included). List and description of specific aims, divided into Primary

6 Objectives and Secondary Objectives. The experimental design for each specific aim / objective should be reported as well. Objectives should be achievable within the Proposal and the foreseen timeframe (2 years) -not through subsequent developments- and be specific and timed. B2.4 Research Methodology (max 9,000 characters, spaces included): a general description of the envisaged research methodology should allow evaluating weather the Project is feasible or not. The presence/participation of a statistical/methodological unit should be clearly stated if involved in both the Project and the final data analysis. If applicable do specify: I. Inclusion/exclusion criteria for individuals/patients to be enrolled/used in the study; II. Type of planned intervention(s), including a detailed description of technologies, specific interventions, exposure factors, etc. III. Health Care/Clinical Setting: inpatient vs outpatient setting (inpatient setting general hospital, (highly) specialized hospital; community hospital; local hospital; long-term health care facility.-; outpatient setting: ambulatory setting, home-based health care setting.) IV. Expected Outcome(s): a distinction between Primary and Secondary Outcomes is required; mentioning unpredictable, yet possible adverse outcomes along with alternative plans, would be considered a plus. Outcome measure system(s): list and description of the optimal system(s) envisaged for outcome appraisal, motivating the choice. V. Samples number / sample size of the target population: statistical sample size of the target population needed to carry out the study, how it has been estimated, and time estimated for individuals/patients enrolment, samples acquisition, data capture. VI. Data collection (modality and timing) and analysis: a detailed description of methods (e.g. paper / electronic medical records; current literature and/or specific archives; active follow up; evaluation by clinical personnel, patient-reported outcome.) as well as internal data validation methods (comparison between sources, comparison between data collectors..) have to be specified. Variables and measures foreseen for controlling for confounding and bias should also be clearly stated. VII. Potential risks / problems and alternative strategies. VIII. Plan for protection of human subjects from research-related risks (for Clinical research only). B3. Feasibility B3.1 Equipment, facilities and resources available at the participating Institutions (max 2,500 characters, spaces included). List of the infrastructures (i.e. facilities and main equipments), capabilities (relevant skills) and capacities (technical, organizational, etc.) needed to carry out the Project, either already available at the participating Institutions, or that can be purchased as services. B3.2 Interaction among Research Units (max 3,000 characters, spaces included): a concise description of synergy, interconnections and complementarity among participating Research Units.

7 B3.3 Principal Investigator Curriculum Vitae (max 3,000 characters, spaces included). A brief description of the achievements of the PI, unequivocally and unmistakably demonstrating a promising track-record in the relevant research field. Potential for research independence and evidence of maturity should be stressed, as well as scientific leadership potential. B3.4 Principal Investigator List of relevant Publications: list up to 10 significant publications in international peer-reviewed scientific journals, published in the period For Reference formatting see guidelines at B The PI position among the authors (listed in their original order) should be highlighted. If the PI is the 7th author (or later) in the list, please, do report all the authors. The journal Impact Factor should be indicated as well for each publication in the list. The Impact Factor must be that of the year of publication, or as close as possible if not available. B3.5 Curriculum vitae (2,000 characters, spaces included) and relevant publications of Research Units Scientific Coordinators. List up to 5 publications relevant for the presented Project published in peer-reviewed scientific journals in the period For Reference formatting see guidelines at B B4. Timeline B4.1 Milestones and Deliverables (max 2,000 characters, spaces included). List any milestone (scheduled event, signifying the completion of a major deliverable or a set of related deliverables, used as a checkpoint to validate how the Project is progressing) and deliverable (e.g. reports, guidelines, data entry in databases, indicators, services, clinical pathways, medical procedures, protocols, software development, meetings, publications ). B4.2 A Gantt chart must be uploaded separately. The Gantt chart is a graphical representation of the planned timing of the different milestones. The Expected Duration of the Project is the total time, expressed in months (max 24 months), where month 1 is the starting date of the grant agreement. B5. Transferability to, and impact on, the Regional Healthcare Service (max 2,000 characters, spaces included). Describe how the Proposal is supposed to positively impact the Regional Healthcare Service in the short/medium/long-term horizon, stressing clinical practice, medical care, organizational features, and economic aspects. A list of the most appropriate qualitative and quantitative Indicators to assess and measure the impact of the presented Project should be provided, also explaining the rationale behind their choice. Describe how the results obtained in the relevant setting of the current study could be transferred to the Regional Healthcare Service, including possible limitations that might hamper transferability. Form C. Suggested Reviewers Please, fill in this (optional) Form by following the instructions therein provided.