CLINICAL STUDIES GUIDELINE FUNDING APPLICATION

Transcription

1 CLINICAL STUDIES GUIDELINE FUNDING APPLICATION Applications for Full Study Funding (over 30,000)... 2 Applications for Pilot / Feasibility Funding (Under 30,000)... 2 Applications for Virements (movement of allocated costs between categories and/or years)... 2 Applications for Extended Timeline No Cost Extension... 3 Applications for Supplementary Funding Below 60, Applications for Supplementary Funding Above 60, Process Overview... 4 ACCESS TO GRANT TRACKER... 4 STEPS FOR COMPLETION AND SUBMISSION OF YOUR ONLINE APPLICATION... 4 General Funding and Award Principles... 5 Who can apply... 5 Terms and Conditions of Award Governance and Study Management... 5 Industrial Support... 5 Release of funds... 6 What we fund Directly Incurred Costs... 6 ARCO Research Costs... 6 Salaries... 7 Clinical Studies Subcommittee Specific... 8 Expenses / Consumables... 8 Equipment / Apparatus... 8 Completion of Clinical Studies Grant Application Form... 9 Project Summary... 9 Key Characteristics... 9 Participating Centres... 9 Study Management... 9 Steering Committee Membership... 9 Research Network Support... 9 Treatment Costs... 9 Salaries versus Expenses/Consumables... 9 Additional Details... 9 Page 1 of 9 Version June 2011

2 Applications for Full Study Funding (over 30,000) Following peer review, applications are considered by the Clinical Studies Sub Committee (CSS) twice per year in March and October; there is no limit to the application financial value or study duration. Applications for funding of clinical studies should be submitted via involvement with an Arthritis Research UK Clinical Studies Group (CSG). Once the CSG has approved that the proposed application is in line with the CSG Strategy and supported by international peer commentary Investigators should identify and approach a registered Clinical Trial Unit (CTU) to work with and develop the methodology in more detail together with the costing. A member of the CTU should be a co applicant. The trial statistician is required to approve the submission of the application (signatory) and would usually be a co applicant but does not have to be a co applicant. The full application form should be completed in line with the guidance herein and with reference to Department of Health guidance contained within: Attributing revenue costs of externally-funded non-commercial research in the NHS (ARCO) - Dec 2005 Responsibilities for meeting Patient Care Costs associated with R&D in the NHS - HSG(97)32 Applications for Pilot / Feasibility Funding (Under 30,000) Funding is available up to a maximum of 30,000, to be adjudicated following peer review by the Clinical Studies Sub Committee outside of their biannual meetings; there is no limit to the duration of the project. Applications for funding of clinical studies should be submitted via involvement with an Arthritis Research UK Clinical Studies Group (CSG). Once the CSG has approved that the proposed application is in line with the CSG Strategy and supported by international peer commentary Investigators may submit an Application. A pilot study is a version of the main study that is run in miniature to test whether the components of the main study can all work together. It is focused on the processes of the main study, for example to ensure recruitment, randomisation, treatment, and follow-up assessments all run smoothly. It will therefore resemble the main study in many respects. In some cases this will be the first phase of the substantive study and data from the pilot phase may contribute to the final analysis or at the end of the pilot study the data may be discretely analysed. A feasibility study is to conduct pieces of research to estimate important parameters that are needed to design the main study. For instance: standard deviation of the outcome measure, which is needed in some cases to estimate sample size, willingness of participants to be randomised, willingness of clinicians to recruit participants, number of eligible patients, characteristics of the proposed outcome measure and in some cases feasibility studies might involve designing a suitable outcome measure, follow-up rates, response rates to questionnaires, adherence/compliance rates etc. Feasibility studies for randomised controlled trials may not themselves be randomised. If a feasibility study is a small randomised controlled trial, it need not have a primary outcome and the usual sort of power calculation is not normally undertaken, the sample size should be adequate to estimate the critical parameters (e.g. recruitment rate) to the necessary degree of precision. The application form for Pilot/Feasibility grants contains the same content as the application form for a full Clinical study. Where a given section is not applicable, applicants must provide an explanation regarding why the section is not relevant. Applications for Virements (movement of allocated costs between categories and/or years) An application may be made via the online Grant Tracker system - in the My Grants section there is an option to submit such a request. Page 2 of 9 Version June 2011

3 Applications for Extended Timeline No Cost Extension An application may be made via the online Grant Tracker system - in the My Grants section there is an option to submit such a request. Applications for Supplementary Funding Below 60,000 Following peer review such applications are considered by the Clinical Studies Subcommittee outside of their biannual meetings. Applications for supplementary funding must be supported by the Steering Committee and Clinical Study Group. With CSG approval an application may be made via the online system Grant Tracker - in the My Grants section there is an option to submit such a request, the option for Monetary Extension is permittable for this grant category only. Applicants should submit a Justification (currently this section is open text with no word count limit) and a detailed budgetary breakdown of the requested Salaries / Expenses / Equipment. Applications for Supplementary Funding Above 60,000 Following peer review such applications are considered by the Clinical Studies Subcommittee at their meetings twice per year in March and October. Applications for supplementary funding must be supported by the Steering Committee and Clinical Study Group. With CSG approval an application may be made via the online system Grant Tracker by completion of new full application form. Page 3 of 9 Version June 2011

4 Process Overview Applications are accepted from recognised UK academic organisations via the online system Grant Tracker. Specific guidance for Grant Tracker usage is available on the website. ACCESS TO GRANT TRACKER - You and the study Co applicants and the 4 required submission Signatories (Study Statistician, CTU Representative, Finance Officer and Head of Department) must first Register for Grant Tracker access. Registration instructions for Grant Tracker are provided on the website Following Registration your Co applicants and Signatories will be required to be available at certain time points to logon and complete tasks, all should be made aware of deadline dates: - initial confirmation of their involvement on the study - approval of the content of the application (co applicants only) - approval of the submission of the application STEPS FOR COMPLETION AND SUBMISSION OF YOUR ONLINE APPLICATION You can SAVE and CLOSE your application at any time as a work in progress: a) Login in and Create initial Application Form - Enter basic details - Add Co-Applicants and Signatories details - Populate application form with detailed information b) ACKNOWLEDGING INVOLVEMENT Co applicants and Signatories - Co-Applicants receive requesting confirmation of their involvement in the study - Co-Applicants log into system and acknowledge involvement - Signatories receive s requesting confirmation of their involvement in this study - Signatories log into system and acknowledge their involvement c) APPROVING THE APPLICATION Co applicants - Once the Application content is completed Co-Applicants must Approve it - The Application should have full content - Signatories must have completed the Acknowledgment of their involvement - Co-applicants must have Acknowledged their involvement before they can Approve d) VALIDATING YOUR APPLICATION - Before the application can be submitted it must validate successfully. To Validate the Application, open the application form in the online system and click VALIDATE you will be advised of any areas still requiring attention - When all Validation issues are resolved SAVE and CLOSE your application - You are next ready to Submit, after which you can no longer make any changes e) SUBMITTING YOUR APPLICATION Co applicants and Signatories - From the Application Details screen Click SUBMIT - The named Statistician will receive an requesting they log in and APPROVE - The CTU rep. will then receive an requesting they log in and APPROVE - The Finance Officer will then receive an requesting they log in and APPROVE - The Head of Dept will then receive an requesting they log in and APPROVE - The Application Submission Process is then Completed Also submit as attachments Evidence of Centre willingness to participate and recruit - Letter Evidence of institutional willingness to take Sponsor Role - Letter All collaborators who are not co-applicants must provide a letter of support Do not send papers that are in press, if a reviewer asks for them, we may request these Items of equipment greater than 5,000 must be supported by a written estimate. Risk assessment for determination of need for DMC. Page 4 of 9 Version June 2011

5 General Funding and Award Principles Who can apply Our research grants and research fellowships may only be held in universities, hospitals or recognised academic research institutes in the UK. Individuals who are employed by, or whose salary derives from, a commercial organisation are not normally eligible to apply for an Arthritis Research UK grant. Employees based overseas are acceptable as co applicants. All collaborators associated with an application who are not co-applicants are required to provide a letter of support with the application. Recruiting centres do not necessarily have to be co applicants (can alternatively be collaborators or listed as a recruiting centre only.) Terms and Conditions of Award Governance and Study Management The Clinical Studies Conditions for the of Award of a Grant require you to submit or notify to Arthritis Research UK the following: Written Confirmation of acceptance of Sponsor role and responsibilities before the start of the project Copy of the NHS Permission for studies in England and equivalent for devolved nations First Subject First Visit (FSFV) date within two weeks of this event Last Subject First Visit date (LSFV) within two weeks of this event Copy of the Protocol approved by ethics and any substantial amendments Steering Committee minutes Progress Report on a 6 monthly basis you will be prompted for this activity The Terms and Conditions of Award require study management on the following basis, the Steering Committee Guidelines available on the website should be referenced when writing the application: Arthritis Research UK does not take on the role of Sponsor and should not be considered the Sponsor of the project. Arthritis Research UK takes the role of Funder only; funding is conditional on the identified Sponsor Organisation confirming this role before the start of the project. Based on analysis of the trial risks (by either/or Chief Investigator / Clinical Trial Unit / Sponsor / NHS Trust / Data Monitoring Committee / Trial Steering Committee), adequate monitoring must be in place to fulfil the obligations of the Sponsor as per the relevant regulations. A Trial Management Group (TMG) must be set up to co-ordinate the daily activity of the project. An independent study Steering Committee (SC) must be set up as per Arthritis Research UK standards. Minutes should be lodged with Arthritis Research UK head office within 2 weeks of finalisation. A Data Monitoring Committee (DMC) must be set up as per the assessment and requirements of the Sponsor. Although Arthritis Research UK are not in a position to fund the project on a per patient payment basis, it is expected that the Trial Unit or other trial administrative function will ensure that payment for patient related activities to investigators, networks, other units etc. will be linked to real-time recruitment. Industrial Support Arthritis Research UK will accept industrial support if it is directed towards our strategic goals and is based on genuine research collaboration with the industrial partner(s) or is an independent untied donation. Any individual seeking support for any research activity with an industrial contribution must complete a disclosure form providing details of: a) The nature of the industrial support b) Industrial links of relevance to the project either by the applicant(s) or their department or group. All such material received by Arthritis Research UK will be treated in confidence. Page 5 of 9 Version June 2011

6 Release of funds Experience to date, as for other funders, is that following our award of funding to a study it takes a considerable period of time to work through committee additional queries/requirements and engage in the detailed discussions around the interpretation of non-commercial funding guidelines in order to define the final funding model with relevant clinical research networks. Subsequent to this, finalisation of the protocol to obtain ethical and research governance approval at the clinical sites you will be recruiting from comprises a significant part of the setup time. Following a period of consultation (internal and external, including Clinical Trial Units) from 1st August 2011 Clinical Study grants will, as a pilot initiative, initially receive preliminary funding circa k to facilitate these activities. This will be sufficient to enable appointment of a study coordinator/manager (up to full time with associated costs) for up to one year to complete these tasks. The subsequent award of the full grant will be subject to such approvals for funding structure in full, ethics, research governance, drug supply etc. being in place and is not expected to be subject to additional scientific peer review. Detailed implementation policies around Clinical Studies Subcommittee awards on this basis continue to be clarified, ultimately this enables a letter of award for this initial phase of study start up to be issued within a short period of time. What we fund Directly Incurred Costs In line with other UK medical research charities, we do not provide funds for administrative costs or 'overheads' but fund Directly Incurred Costs only. Standardly the elements of cost headings are: Directly Incurred Costs - the direct costs of research such as Staff (e.g. research assistant salaries) Consumables and other costs directly attributable to the project Equipment Travel and subsistence Directly Allocated Costs - shared costs, based on estimates and do not represent actual costs on a project-by-project basis such as Investigators: the time spent by the Principle Investigator and Co-Investigators Estates Other Directly Allocated - the costs of shared resources, such as staff and equipment Indirect Costs - necessary for underpinning research but cannot be allocated to individual projects, and cover computing and information support, central services, general maintenance and other infrastructure costs. ARCO Research Costs should be formulated in line with Department of Health guidance: Attributing revenue costs of externally-funded non-commercial research in the NHS (ARCO) - Dec 2005 Responsibilities for meeting Patient Care Costs associated with R&D in the NHS - HSG(97)32 Guidance on funding Excess Treatment Costs related to non-commercial research studies and applying for a subvention Specifically points to note are: NHS Support Cost Identifying patients eligible to participate, explaining the study to participants, obtaining informed consent IRAS application Additional patient care costs associated with research studies that end once the study ends Collecting clinical data for research Additional cost of formulating, disguising, storing or distributing placebo or medicine when undertaken or incurred on NHS premises Treatment Cost Providing the intervention Following up - Contemporaneous with clinical care Page 6 of 9 Version June 2011

7 Training to carry out the treatment under investigation - time out being trained Training to carry out the treatment under investigation - NHS staff time in training clinicians Cost of the medicine being researched If not funded by Industry Cost of active comparator medicine(s) Research Cost Collecting clinical data for research It should be carefully considered whether individual components of an Intervention are or would form part of standard care should the intervention be adopted (if not already) or whether they are being conducted purely for research purposes - interventions that are not part of standard care (nor would be part of routine care should the new intervention be adopted) e.g. additional x-rays are research interventions Following up - Not contributing to individual patient management Training where the new skills are required to carry out the R&D activity Training to carry out the treatment under investigation - non-nhs staff time in training clinicians Cost of the placebo Additional cost of formulating, disguising, storing or distributing placebo or medicine on non-nhs premises Pharmacy setup and close out Archiving Salaries Principle Investigator and Co-Investigators time is classed as Directly Allocated Costs and are not routinely funded. Investigators employed on a full time HEFCE basis for research cannot apply for their salaries. Exceptionally co applicants from Clinical Trial Units are permitted to apply for their salaries (or % of), a justification for this action must be provided. The potential for co applicants to be employed on an awarded grants basis (DI) rather than a permanent institutional contract (DA) basis is acknowledged, such co applicants salaries may be accommodated with appropriate justification Main applicants on a grant proposal wishing to apply for his/her own salary must submit the application jointly with a tenured senior member (preferably the head) of the department in which he/she proposes to work. Clinical investigators employed on full time NHS contracts named as applicant or co applicant can apply for payment of Programmed Activity (PA) sessions to allow for release of investigators to conduct their study duties by backfill payment (by locum or otherwise) to cover the released NHS clinical activity, the grant will accommodate application for such nominated salaries. Clinical investigators employed with both academic research (HEFCE) and clinical (NHS) commitments named as applicant or co applicants cannot (other than in exceptional circumstances) apply for payment of Programmed Activity (PA) sessions to allow for release of investigators to conduct their study duties, such activity is deemed to be conducted from within the nominated research time, the given study being considered a chosen research activity. Specifically for co funding there is no scope to apply for a Directly Incurred element of salary from Arthritis Research UK and Directly Allocated element of salary from another funder. It is understood to be best practice for payment of locums to be facilitated as a Directly Incurred cost on a grant and thus is best handled such that backfill funding should be applied for as a salaried position to be confirmed basis, which can be notified to us in name when a locum is actually in post, this can be accommodated if it is facilitative to a given institution. Requested salary costs should be based on a recognised pay model or the host institution s local salary scale, including London weighting if appropriate. We must be advised of the pay model used and, where a local pay model is to be applied, a copy of the appropriate scale must be sent with the application. London Weighting allowance will be payable at the rate appropriate to each host institution. Annual increments must be included which should be based on the host institution s own salary scale, including London weighting if appropriate. Inflationary salary increases for funding in future years must be included in the costs requested. A compound allowance should be factored into the costing for this purpose. The percentage used to calculate the compound inflationary allowance must be the same as the most recent pay award Page 7 of 9 Version June 2011

8 agreed by the institution for the grade on which the individual is to be employed but no more than 5%. A "session" in respect of protected research time is such that 1 session = half a day. Clinical Studies Subcommittee Specific Consultancy costs should be listed as Expenses not Salaries. Justifications for salaried posts should be provided in the Comments section available for each individual. Research Nurses should be listed as Expenses not as Salaried individuals. Clinical Trial Unit staff should be listed as Salaried staff not as Expenses. Fellowships are not funded within clinical studies, justification in support of such a post may be provided for committee consideration. Expenses / Consumables Costs must show sufficient detail (including numbers and the basis of estimation) to enable peer reviewers to make an informed decision. Expenses can include whatever is needed to support the research or post. Consumables such as postage stationery, photocopying should be itemised. The outlined Broad Principles are such that the following costs will NOT be accommodated within the application (some areas are funded by separate application): o Conference travel and fees - Travel to a conference to present Arthritis Research UK-funded research should not be applied for in the grant - Arthritis Research UK grant holders are eligible for travel support which is an additional discretionary allowance on a grant o Publication costs o Open access Arthritis Research UK grant holders are eligible to apply for such fees under separate application o Interlibrary loans - there must be strong justification showing specific needs for the project outlined in the application with confirmation such items are not normally provided by the Institution o Recruitment o Good Clinical Practice training o Indemnity Insurance Equipment / Apparatus Applications for items of equipment greater than 5,000 must be supported by a written estimate. The outlined Broad Principles are such that the following costs will NOT be accommodated within the application (some areas are funded by separate application): o o Computers - there must be strong justification showing that computers will be used specifically for the project outlined in the application and would not normally be provided by the Institution Mobile Phones Page 8 of 9 Version June 2011

9 Completion of Clinical Studies Grant Application Form Additional guidance is available from the HELP menus on each screen of the on line application form. Project Summary Start date should be the date of 1 st activity on the project not the date of first subject recruitment or ethics approval date but the date that somebody does something that incurs as cost against the grant, usually a salary of a coordinator. The start date should not be before the upcoming Clinical Studies Subcommittee date please check these on the website. Key Characteristics Phases I IV apply only to Investigational IMP studies. Number of visits should be number of visits per subject. First Subject First Visit date should be defined allowing sufficient time for Ethics / MHRA / Research Governance approvals to be sought and provided. Coordinated System for gaining NHS Permission (CSP) or equivalent current standard timelines should be referenced when developing the study. Participating Centres A list of brief details of the centres involved in the trial must be provided together with a letter or fax stating the centres willingness to participate in the project. Centres planning to be involved in the study must liaise with relevant parties at their institution to determine whether they would support any identified excess treatment costs of the study. This issue is important to ensure that accrual into the trial is feasible. Evidence of Trust willingness to support such costs of the study must be provided. Study Management It should be outlined how the study requirements will be met by the relevant personnel, both funded roles and co applicant and collaborator roles should be described. o A Trial Management Group (TMG) must be set up to co-ordinate the daily activity of the project. Steering Committee Membership The Terms and Conditions of Award require study management on the following basis, the Steering Committee Guidelines available on the website should be referenced when writing the application: o A Data Monitoring Committee (DMC) must be set up as per a Risk Assessment and requirements o of the Sponsor most likely facilitated via the Clinical Trial Unit. An independent study Steering Committee (SC) must be set up as per Arthritis Research UK standards Suggestions for the Chair and two independent members should be made (in conjunction with their knowledge). Should the application be supported the chair and members will be approved or alternative suggestions made by the Progress Review Committee and this will be communicated to them directly. Minutes should be lodged with Arthritis Research UK head office within 2 weeks of finalisation. Research Network Support The identified NHS service support activities and costs should be outlined; investigators, coordinators and trial units should engage the relevant CLRN at this stage to secure commitment these activities. Treatment Costs A breakdown of the NHS treatment costs should be outlined. The costs of the standard/usual care should be provided. The treatments in the control and experimental arms of the study should be costed. If these costs are different from the normal/usual standard treatment for the condition the difference between the costs should be highlighted as Excess Treatment costs. If you believe that there are no Excess Treatment Cost implications linked to this study then please explain your reasons behind this. Salaries versus Expenses/Consumables Costs related to funding of Clinical Trial Unit posts should be detailed within the Salaries section, indicating the percentage allocation for each role. Costs relating to funding of patient related activities linked to recruitment should be detailed within the Expenses section e.g. research nurses, physiotherapist interventions. Additional Details Facilities, as well as wider description of facilities specific justification of computer costs and interlibrary loans should be given here. Page 9 of 9 Version June 2011