How to Write a Successful Clinical Research Proposal Introduction: FP7 proposals Dr Caitriona Creely, NCP and National Delegate for Health in FP7 1 Webinars Two presentations • • • • • • Basic aspects of FP7 proposals Specific elements of Clinical research proposals Slides will be available afterwards Email in questions Questions not answered today will get an email reply 2 Overview Next call Minimum requirements • • • • • • Topic Consortium Budget Proposal structure 3 Key messages • • • • • Upcoming call for proposals for FP7 Health (EU funding scheme) Substantial funding for EU research teams to carry out clinical research projects Most clinical research areas will require only a short EoI first application – worth applying! Webinar: general and specific aspects of application process References for further information NCPs here to help you 4 Next Call in FP7 Health • • • FP7 Health: annual Call for proposals published each summer Next calls will be published July 30th Different deadlines for each call single-stage call (provisional deadline November 10th) two-stage call (provisional deadline October 13th) 5 Minimum requirements Proposals must • Be within scope of topic in published work programme • Have minimum number of eligible, independent participants/ countries from EU MS/AC or as set out in the Work Programme • Observe maximum budget for the topic you are applying for (including any specific budget for SMEs) 6 Fit with topic 7 FP7 Health topics • • • • • • FP7 Health is not bottom-up! Proposals you submit must fit a published topic in annual work programme Topics change each year This year 8 clinical research topics Find out if any topic is of interest to you by reading the work programme document This year work programme published early as “orientation paper” available for download now 8 http://cordis.europa.eu/fp7/health/home_en.html For more information: CCreely@hrb.ie 9 Initial proposal ideas When formulating the idea, ask the following questions: • What problem are you trying to solve? Topic in call = problem defined by the EU, your proposal is the solution • Is it a European Problem? Scale, citizens affected, need for cooperation • Is there a solution already available? Why doesn’t the current solution work? • What’s the urgency of this work, why now and what will be the outcome if this research isn’t undertaken? • Why this consortium? Are you the best people to do this work? 10 Consortium 11 The Consortium • • • Each project proposal requires a “coordinator” and at least the minimum required number of other partners Consortium prepares proposal which addresses the topic, with the work described using Work packages Coordinator has specific responsibilities (e.g. submitting the proposal) and is the point of contact with the Commission 12 Decision: consortium • Lead a consortium Experience Leadership in field • Partner in a consortium Want to learn, expand network Selling point for topic you’re interested in – what can you offer the consortium? Make sure you’re happy with coordinator! 13 Tools for Consortium Building • How can I find partners? • • • • Personal contacts Networking at conferences/brokerage events www.smesgohealth.org www.lifecompetence.eu <- Very Useful! 14 15 Current coordinators • • • CORDIS also has a list of FP7 projects funded http://cordis.europa.eu/fp7/projects_en.html Not as much information – partner names not given Newer projects not listed – only after grant signature 16 COST Networks • • • • Free to join Networking activities paid for Check existing networks on www.cost.esf.org Irish contact point: Rita Ward, Enterprise Ireland 01 727 2767 17 Consortium – final points • • • • • Happy to work with people for 1, 3, 5 years Up to the job, relevant, recent publications/expertise Industry partners when relevant to tasks Don’t carry extra partners! Management has to be smooth (internal or outsourced to company) 18 Budget 19 Budget Funding from EU % of eligible costs up to a maximum amount (e.g. €3m, €6m, €12m) • • • • • actual incurred during duration of project in accordance with usual accounting and management principles recorded in accounts of beneficiary Eligible costs have to be worked out for each consortium partner, and charged according to what type of work they do in the project 20 Eligible cost = Direct cost + Indirect costs • Direct costs – easily measured e.g. receipts Examples: Personnel (timesheets!), Travel and subsistence, Durable Equipment, Consumables, Subcontracting Indirect costs (Overheads) e.g. rent, heating and lighting etc. • Overhead rates for different participants • Public Bodies/Universities/SMEs: Actual overheads for the project or Flat-rate Overheads • 60% flat-rate of direct costs Multinationals/large companies: Most have a/c systems that identify overhead costs per project, or 20% Flatrate can be applied How much will I get? First calculate the Eligible cost (direct costs + overheads) • You get a % Eligible Cost depending on: What activity you do in the project (R&D/training/management/dissemination/ demonstration, or a combination) • Guide for Applicants (available when call is published) explains activities: example • Activities • Research (RTD) means activities directly aimed at creating new knowledge, new technology, and products including scientific coordination. • Demonstration means activities designed to prove the viability of new technologies that offer a potential economic advantage, but which cannot be commercialised directly (e.g. testing of product-like prototypes). • Other training, networking and dissemination (including publication costs), IPR protection….. • Management legal, contractual, audit costs etc See GFA for cost categories and FP7 finance helpdesk for FAQs 24 Reimbursement of eligible costs • Maximum reimbursement rates of eligible costs Research and technological development = 50% or 75%* Demonstration activities = 50% Other activities (including management) = 100% * SMEs, public bodies, research organisations (non-profit) 25 26 Example partner B, University RTD (75%) Personnel 100,000 Subcontracting 0 Other 0 Indirect (60%) 60,000 Budget 160,000 Requested EC Contribution 120,000 27 Example partner B, University RTD (75%) Other (100%) Personnel 100,000 40,000 Subcontracting 0 0 Other 0 20,000 Indirect (60%) 60,000 36,000 Budget 160,000 96,000 Requested EC Contribution 120,000 96,000 28 Example partner B, University RTD (75%) Other (100%) Total Personnel 100,000 40,000 140,000 Subcontracting 0 0 0 Other 0 20,000 20,000 Indirect (60%) 60,000 36,000 96,000 Budget 160,000 96,000 256,000 Requested EC Contribution 120,000 96,000 216,000 29 • • General rule: In FP7 all departments, faculties or institutes which are part of the same legal entity must use the same system of cost calculation => Consult research office/finance office when you are putting the budget together Can’t ask for more money later on, so include all relevant salary increments, costs, audit certificates etc Check your internal institutional deadlines, so they have time to assist you with the budget! 30 Overview Next call Minimum requirements • • • • • • Topic Consortium Budget Proposal structure 31 Proposal Structure 1. S/T 2. Implementation 3. Impact 4. Ethics 5. Gender issues GFA explains how to fill in each section 32 S/T Scientific and/or technical quality, relevant to the topics addressed by the call • • • • Concept and objectives Progress beyond the state-of-the-art S/T methodology and associated work plan: WP lists, milestones, PERT chart etc 33 S/T: evaluators look for • • • • • • • • Clear AIMS – with motivation/hypothesis OBJECTIVES (realistic) What is the state-of-the-art (current knowledge) What is either: Lacking from the SOTA/Needed to move it forward How is your idea complementary or better that the approach of others? Users: who are they and how will they benefit? Methodology (clear!) Appropriate, relevant partners with necessary skills 34 Implementation Implementation • • • • • Management structure and procedures Individual participants Consortium as a whole Resources to be committed 35 Implementation: evaluators look for Management • • • • • • Clear Diagram! Obvious leader (scientific and project management) Decision-making involves all partners Conflict resolution Clear communication channels, meeting schedule People/Institution • • • • Relevant scientific track record Delivered in the past Quality of host (facilities/support) Resources • • • • • Clarify budget In-kind contributions/national co-funding Don’t inflate costs Make sure budget is sufficient (e.g. inflation, salary increments) 36 Impact Impact • • • Expected impacts listed in the work programme Dissemination and/or exploitation of project results, and management of intellectual property 37 Impact: evaluators look for Impact • • • • • Check work programme for required inputs Describe levels of impact (e.g. EU level, national level, patient level) How will outputs translate to impact (refer to deliverables) What is the advantage of an EU approach? Dissemination • • • • • How do you plan to disseminate results? May need WP on dissemination/IPR Who is in charge of IPR? Diagram may be useful (e.g. process of checking for IP opportunities before publications) 38 http://www.yellowwindow.be/genderinresearch/index_downloads.html For more information: CCreely@hrb.ie 39 Write for the evaluators (1) • • • • • Avoid jargon – it can irritate evaluators! Respect the page limits and the order of the various sections (check GFA and use the template provided) Check spelling and grammar Have the evaluators in mind, remembering that not all evaluators will be experts in your particular topic… …. but – they will be experienced scientists in the discipline and you may get an evaluator who is a real expert so your ideas need to be credible and based on a sound theoretical foundation 40 Write for the evaluators (2) • • • Make it easy to find information (refer to specific WPs, milestones etcetera) Get a colleague to read the full proposal – if they can’t understand the objectives, neither will the evaluators Read the proposal to see how it flows – avoid unnecessary repetition and contradictory statements 41 Single-stage Evaluation Submitted proposals marked out of 15 • S/T (5 marks, threshold 3/5) • Implementation/Management (5 marks, threshold 3/5) • Impact (5 marks, threshold 3/5) • Overall threshold 10/15 • Have to address all ethical issues sufficiently 42 Two-stage evaluation (Stage1) • • • • • • Cover page (1 page) S/T (5 marks, threshold 4/5) Impact (5 marks, threshold 3/5) Overall threshold 8/10 S/T and Impact max. 5 pages + 1 page for consortium/budget If retained for stage 2, 1 in 3 chance of success 43 On line submission (EPSS) Call-specific! Check you have chosen the right scheme Password access for coordinator + partners Coordinator should register as soon as the call opens Part A administration - fill in forms online • • • • • • • Save forms and validate to check for mistakes/omissions – partners can only access A2 Part B proposal details - download template and upload one file containing the research proposal in pdf format only! Part B: font size, non-encrypted, no special characters in filename, printable, looks good printed in B/W 300dpi Key factors for success in applying for FP7 Funding • • • • • Competition is tough: only the best projects get funded The proposal must address the topic within the work programme The consortium of partners must be excellent and appropriate for the tasks (select the right partners) The proposal must address all 3 evaluation criteria Convince the evaluators Respect the basic rules – deadlines (5pm CET => 4pm GMT!!!), No participants 45