Guidance Notes NIHR Clinical Trials Fellowship Round 6 June 2017

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1 Guidance Notes NIHR Clinical Trials Fellowship Round 6 June 2017 Trainees Coordinating Centre

2 Introduction... 3 Eligibility... 3 Scope... 4 Funding... 4 Management... 4 Selection Process for Applications... 4 Assessment Criteria... 5 Closing Date... 5 Submitting the Application(s)... 6 SECTION: Applicant Details... 7 SECTION: Applicant CV... 7 SECTION: Case for Support... 8 SECTION: Clinical Trials Unit... 9 SECTION: Current Supervisor s Statement of Support... 9 SECTION: Finances... 9 SECTION: Department of Health Monitoring Information SECTION: Participants SECTION: Declarations and Signatories Finance Section Equal Opportunities and Diversity NIHR Privacy Policy Enquiries Signatory Flow Diagram Further Guidance for Signatories and Participants

3 Introduction On behalf of the National Institute for Health Research (NIHR), the NIHR Trainees Coordinating Centre (TCC) is launching the sixth round of NIHR Clinical Trials Fellowships. The NIHR through its various national research programmes ( commissions new research of direct relevance to the NHS. Many of these studies involve clinical trials. The conduct and execution of well-designed trials requires partnership with clinicians, other trialists and methodologists and ideally builds on the experience, expertise and infrastructure provided by Clinical Trials Units (CTUs). Clinical Trials Fellowships (CTFs) are designed to support existing NIHR trainees with an interest in, and experience of, working with clinical trials as part of their current training award who would benefit from further training within the setting of a CTU (in receipt of NIHR CTU Support Funding). The training programme should expose the trainee to all aspects/stages of trials and should not limit individuals to one study. These guidance notes are intended to help individuals and CTUs who are eligible to apply for a NIHR CTF complete an application. New Application Process Please note all applications for this round must be made using TCCi, which can be accessed via These guidance notes must be read in full in order to complete this process. Eligibility NIHR CTFs are open to existing NIHR trainees in partnership with CTUs in receipt of NIHR CTU Support Funding. Applications should be submitted jointly by the CTU and the trainee. NIHR trainees must: Hold one of the following awards at the time of application: NIHR Doctoral Research Fellowship (DRF) NIHR Postdoctoral Fellowship (PDF) NIHR Career Development Fellowship (CDF) NIHR Clinical Lectureship (CL) (part of NIHR s Integrated Academic Training Programme, including NIHR recognised locally-funded CLs) NIHR Clinician Scientist Award HEE/NIHR Integrated Clinical Academic Programme Clinical Doctoral Research Fellowship (ICA CDRF) HEE/NIHR Integrated Clinical Academic Programme Clinical Lectureship (ICA CL) NIHR Clinical Academic Training Clinical Doctoral Research Fellowship (CAT CDRF) NIHR Clinical Academic Training Clinical Lectureship (CAT CL) NIHR Healthcare Scientist Doctoral Research Fellowship (HCS DRF) NIHR Healthcare Scientist Postdoctoral Research Fellowship (HCS PDF) Be involved in a clinical trial as part of their training award; and 3

4 Have continued support from their employing organisation for the duration of the fellowship (this may or may not be the same as the institution that hosts the CTU). Applicants undergoing medical or dental specialty training must also have permission from their Postgraduate Dean for time out of their training programme. CTUs must: Be based in England; and Be in receipt of NIHR CTU Support Funding, with at least one year of their current contract in force at the deadline for submission of an application. Individual CTUs may be involved with up to two separate applications per round, supporting different trainees. Scope NIHR CTFs provide 6 months dedicated time (or 8 months part-time at 75% Whole Time Equivalent (WTE) or 10 months part-time at 60% WTE) for the trainee to undertake activities that expose them to a range of clinical trials and studies. NIHR is looking for innovative proposals that expose trainees to all aspects and stages of clinical trials and studies and should not limit the individual to a single project where they would only see one stage in depth. Training programmes should provide trainees with hands on experience that considers the issues involved in the design, conduct, analysis, and interpretation of all trials (including public health based research). NIHR expects trainees to demonstrate clearly how they would draw on their existing NIHR-funded research and how this additional training would support their future career either as a clinical trials collaborator or principal investigator. Funding Each NIHR CTF will attract full cost of employment (including National Insurance, Superannuation and London Weighting where appropriate) for the trainee for the 6 month period plus costs to support their clinical trial training activities (capped at 5,000 for each award). Up to 80% of Full Economic Costs (FEC) will also be paid to Higher Education Institutions. Fellows will need to start the fellowship between 1 January 2018 and 1 March 2019, subject to the CTU having continuing NIHR CTU Support Funding in place for the duration of the fellowship. Management Successful NIHR CTFs will be required to submit a progress report at the end of the fellowship to NIHR TCC. The host organisation is also required to submit a financial reconciliation following completion of the award. Application Procedure All CTUs in receipt of NIHR CTU Support Funding will be contacted and invited to participate in the round. Details of participating CTUs will be available on the NIHR website. 4

5 Potential candidates will be invited to apply for an NIHR CTF in partnership with a participating CTU. All applicants must have contacted the CTU where they are interested in working by Wednesday 12 th July 2017, stating their name, contact details, current NIHR award, projected end date, summary of their trials exposure to date, and reasons for applying. Completed applications must be submitted to NIHR TCC by 13:00 on Thursday 24 th August Applications will be reviewed and scored by an expert panel, which makes recommendations to the Department of Health. The outcome will be announced during Autumn Assessment Criteria Applications for NIHR CTFs will be assessed against the following criteria: The potential of the trainee to undertake high-quality clinical trials in their future career The impact the fellowship will have on the trainee s career development and trajectory The extent to which the Fellowship will provide a high-quality and stimulating research training experience in all aspects of clinical trials of relevance to the NIHR The provision of academic supervision and support The extent to which the Fellowship will support professional and personal development Closing Date Applications must be made using TCCi - Applications must be submitted by 13:00 on Thursday 24 th August Late applications will not be considered under any circumstances. Further guidance for submitting the application on TCCi is available from page 6 onwards. 5

6 Submitting the Application(s) Please note: Applications must be made using TCCi. Completing the online application form Role Sections to complete Must complete all sections. Lead Applicant The Current Supervisor s Statement of Support should be completed in conjunction with the Current Academic Supervisor, the Clinical Trials Unit section should be completed in conjunction with the CTU Representative and the Finance section should be completed in conjunction with the Finance Officer. CTU Representative Clinical Trials Unit (in conjunction with Lead Applicant) Current Supervisor Current Supervisor s Statement of Support Finance Officer Finance (in conjunction with Lead Applicant), Declarations and Signatories Head of Department Declarations and Signatories 6

7 SECTION: Applicant Details Personal Details ORCID id Proposed Host Organisation Proposed Clinical Trial Unit Proposed Start Date and Award Duration Professional Background Specialty Training Current Positions Current NIHR Award Have you Previously Held a NIHR Award? Please note that your personal details are automatically completed from the information you have provided in the 'Basic Information' section of the 'Manage My Details' page. These can be updated via the TCCi Home Page or by following this link The NIHR is an ORCID member and encourages all researchers to obtain this persistent digital identifier that distinguishes you from every other researcher. Lead Applicants must include an ORCID id in their application. Without it, your application will not be validated and you will not be able to submit. Please enter the name of the proposed host organisation who will administer the Clinical Trials Fellowship. Please select the Clinical Trial Unit where the fellowship will be based. Please select the proposed start date and award duration. Start dates range from 1 st January 2018 to 1 st March 2019 and award duration options are 6 months at 100% WTE, 8 months at 75% WTE, or 10 months at 60% WTE. Please select the one option which best describes your professional group. Please indicate whether you are currently undergoing medical or dental specialty training. If you select Yes, then you will need to add a Postgraduate Dean in the Participants section. Add details of your current positions of employment. Please select which NIHR award you currently hold. Please specify if you have previously held any NIHR award(s) and select all that apply from the list available. SECTION: Applicant CV Professional Qualifications Please give full details including dates of qualifications. This section can be edited via Manage My Details when you log into TCCi. To access this from the application form screen, click Save and Close and then choose Manage My Details from the menu on the left hand side on the next screen. 7

8 Present and Previous Positions Held Recent Relevant Publications Relevant Prizes, Awards and Other Academic Distinctions Research Grants Held Employment Breaks Please detail your current and previous posts (most recent first), including start and end dates. This section can be edited via the Manage My Details section. List any publications relevant to this application in which you are a named contributor or author. Please list peerreviewed publications, other publications, other research outputs (for example abstracts published from conferences). These can be updated via Manage My Details, Update CV section on the main login page. Please list all relevant information with regards to prizes, awards and distinctions. These can be updated via Manage My Details, Update CV section on the main login page. Please provide details of any grants that you currently hold or have previously held. Please list in date order, with the most recent first. Please provide any information you feel is relevant regarding breaks in your employment record. Professional Body Membership SECTION: Case for Support If you are registered with the regulatory body or council of your profession, please indicate which council you are registered with and the registration number. This information is updated via Manage My Details, Basic Information section on the main login page. Summary of Experience Please detail your progress to date in your existing fellowship or lectureship in relation to your clinical trial. Please outline the relevant stages of a clinical trial for which you have experience and highlight the areas where further training would be appropriate. Overview of Training Please indicate how this training will build on your existing experience. Word Limit: 1000 Word Limit: 500 Career Intentions Please outline your future research and career intentions, including what ways this award will add value to your career. Word Limit: 500 8

9 SECTION: Clinical Trials Unit Contact Details for the Clinical Trials Unit CTU Proposed Training Programme Training Supervision This section is filled out by the Lead Applicant and the CTU representative. The Lead Applicant must provide contact details for the CTU representative. The CTU representative must provide a clear outline of the training programme. The training should provide hands on experience for all stages of clinical trials and build on the expertise of the unit. This may include involvement in the development of trial protocols, conduct, analysis and interpretation of ongoing trials in the unit. A timetable and milestones for the proposed training programme should be included. Word Limit: 1750 The CTU representative is required to give details of up to three members of the CTU who will be involved in the training programme, their role in the CTU, and how their expertise will be used to support the trainee. SECTION: Current Supervisor s Statement of Support Current Supervisor s Statement of Support SECTION: Finances Introduction Current and Proposed Salary Costs Fellowship Costs: Salary Costs All applications must include a statement of support that is completed by the trainee s current academic supervisor. Please include all relevant costs within the application, as NIHR is unable to provide additional funding for items once the contract is signed. Further instructions for this section are on page 14. Please provide details of the current and proposed salaries. This should also include grade, increment date, and justifications where required. A copy of the host institution s pay scale must be attached in the relevant area at the bottom of the finance section of the form. Please note this must be either a Word document or PDF. Please provide salary details for the Lead Applicant for each year including Basic Salary, National Insurance, Superannuation and London Weighting if appropriate. All salary costs must be at current prices, without inflation, as this is at the discretion of the Department of Health. Increments, where appropriate, can be included. 9

10 Training and Development HEI Indirect Costs NIHR TCC will make a maximum contribution of 5,000 for costs associated with the proposed training programme. Please itemise and describe fully the costs. Please provide estimates if exact costs are not available at the time of application. Total HEI indirect costs must be fully justified. HEIs are permitted to claim estate and other indirect costs. These costs are calculated on the basis of TRAC methodology. Proposals from other types of institutions/organisations should leave this section blank. SECTION: Department of Health Monitoring Information Introduction UKCRC Health Research Categories UKCRC Research Activity Codes Please complete all questions with reference to your research proposal. This will be used solely by the Department of Health and the NIHR for accountability, audit, and monitoring purposes. The research classifications contained in this section are those developed by the UKCRC to classify and analyse health research. You should choose one health category from the list to classify your proposed research. If your proposed research spans more than one health category you can make a second choice. Do not enter more than two health categories. Further information on classifying research can be obtained from the following website: You should choose one research activity from the lists to classify your proposed research. If your proposed research spans more than one research activity you can make a second choice. Do not enter more than two research activities. You will see that the main 8 categories are further subdivided. To help you choose the correct subdivision you should use the guidance found at in the downloadable Health Research Classification System booklet. 10

11 SECTION: Participants You are required to supply the names and addresses (if not already registered on TCCi) of the individuals who will be undertaking participant roles as part of your application. Everyone named in this section will be acting as a participant to your application and will need to agree to be part of this application. Participants are required to review the declaration for the role before confirming participation. By confirming participation, they are acknowledging their involvement and input into this application and agree to be involved in it before it is submitted. You must ensure all participants have confirmed their participation before your application can be submitted. Participants Please enter details for the following people: CTU Representative. Current Academic Supervisor. Postgraduate Dean (if applicable). You can only do this if you have answered yes to the question Are you still undergoing medical/dental speciality training?' in the Applicant Details section. CTU Representatives and Current Academic Supervisors must confirm their participation on your application and complete the relevant section of the application before you will be able to press the submit button. Postgraduate Deans (if applicable) must confirm their participation on your application before you will be able to press the submit button. They will have no further action to take in the submission process. Details of the individuals, who will be required to approve your application after submission (signatories), before the application deadline, should be entered in the 'Declarations & Signatories' section. Please note it is often the case that one or more of the participants named in this section are also named in the "Declaration and Signatories" section of the form. 11

12 SECTION: Declarations and Signatories Conflicts of Interest Lead Applicant Please declare any conflicts or potential conflicts of interest that you may have, including any facts that, should they come to light at a future date, could lead to a perception of bias. Include any relevant personal, non-personal and commercial interest that could be perceived as a conflict of interest, examples include (however, this list is not exhaustive), secondary employment, consultancy, financial or commercial gain (pensions, shareholdings, directorships, voting rights), honoraria, etc. In a case of commercial sector involvement with the application or the study, please state clearly the relationship to ownership of data, access to data, and membership of project oversight groups. This must be completed by you, as the Lead Applicant, by ticking the box at the end of the declaration section. You should sign to confirm that: The information provided in the application is true, accurate and complete. You understand the terms and conditions of the NIHR Clinical Trials Fellowships. If successful, that you will undertake the research activities according to good practice. You understand and agree to the use of personal and other data. You have read the NIHR Carbon Reduction Guidelines and, where possible, taken steps to reduce the carbon emissions generated by any research. You will also be required to supply the name and address for all the people listed below who will be required to complete a declaration, and in some cases, part of the application form: Head of Department. Administrative Authority or Finance Officer. Please note: by authorising and submitting an application the Lead Applicant is accepting the process by which an application is assessed and agreeing to abide by the conditions under which an award may be offered. Please note: when the form is complete and all validation errors have been addressed, the Lead Applicant may submit their application. Clicking the submit button does not send the application to NIHR TCC for consideration; it alerts the authorised signatories (Head of Department and Finance Officer) that the form is ready for final approval. Only when all signatories have approved the application is it then complete and is submitted to NIHR TCC. Please allow plenty of time before the closing date for this process to take place. 12

13 The Lead Applicant must have previously added the name and address of the Head of Department of the host organisation who will sign off the application on behalf of the host organisation. In signing, the Head of Department is indicating: Head of Department Their approval of the application. Their willingness to offer an appointment to a Fellow (if successful) for the tenure of the award subject to their normal employment practices. Their commitment to providing the support necessary to make any award a success. Their approval of the salaries and other costs sought. Their acceptance of the terms and conditions associated with the NIHR Clinical Trials Fellowships. Please note: by authorising and submitting an application the host organisation is accepting the process by which an application is assessed and agreeing to abide by the conditions under which an award may be offered. As the host organisation will need to confirm their participation in the application, it is recommended that the signatories section is completed as soon as is practically possible in order to allow them access to the form. Please note: when the form is complete and all validation errors have been addressed, the Lead Applicant may submit their application. Clicking the submit button does not send the application to NIHR TCC for consideration; it alerts the authorised signatories (Head of Department, Finance Officer) that the form is ready for final approval. Only when all signatories have approved the application is it then complete and is submitted to NIHR TCC. Please allow plenty of time before the closing date for this process to take place. The Lead Applicant must have previously added the name and address of the Finance Officer of the employing institution who will be asked to complete the finance form and a declaration. Finance Officer As the Finance Officer will need to confirm their participation in the application and then complete their relevant sections, it is recommended that the signatories section is completed as soon as is practically possible in order to allow them access to the form. Please note: when the form is complete and all validation errors have been addressed, the Lead Applicant may submit their application. Clicking the submit button does not send the application to NIHR TCC for consideration; it alerts the authorised signatories (Finance Officer, Head of Department) that the form is ready for final approval. Only when all signatories have approved the application is it then complete and is submitted to NIHR TCC. Please allow plenty of time before the closing date for this process to take place. 13

14 Finance Section The finance section of the application should provide a breakdown of costs associated with undertaking the Fellowship as described in the proposal. General Information NIHR CTFs provide support for trainees to undertake a training programme designed to provide experience and training in all aspects of clinical trials within a UKCRC registered CTU (in receipt of NIHR CTU Support Funding). Each Fellowship will attract full cost of employment (including National Insurance, Superannuation, and London Weighting where appropriate) for the trainee for the 6 month period plus costs to support their clinical trial training activities (capped at 5,000 for each award). Up to 80% of Full Economic Costs (FEC) will also be paid to Higher Education Institutions. The information entered in this section should provide an analysis of the total funds requested to undertake the research proposed and should be based on current prices. These costs will be used to assess value for money. It is in the best interest to undertake a thorough, realistic and accurate costing. You must provide a clear and full justification for all costs. Costs must be provided at current prices. An adjustment for inflation will be made annually thereafter at rates set by the Department of Health. Whilst allowances for incremental increases should be included on the form, nationally or locally agreed pay increases should be excluded. Further itemisation of costs and methods of calculation may be requested to support the application at a later date. Appropriate sub-contracts must be put in place for any element of the research which is to be paid to another organisation. All applications are expected to have appropriate NHS or HEI input into the finance section of the application form. The finance section must be completed by the Lead Applicant in conjunction with the Research Support Office or Finance Office at the host organisation. The host employer institution is the organisation that authorised the application and which, in the event of an award being made, will employ the Lead Applicant. For HEIs in particular this is the individual who is authorised to assist with, and approve, the financial costing of proposals. Lead Applicants must make a copy of these guidance notes available to the Finance Officer in question. The funding requested in the finance section will form the basis of the fellowship should the application be successful. Any revision to the information provided in the finance section shall not be authorised without the provision of suitable justification. All costs provided should be value for money and will be assessed by the NIHR TCC and members of the NIHR CTF review panel. NIHR TCC reserves the right to reject any costs that it considers unreasonable or not fully justified. 14

15 Information on different types of employing organisations Please ensure that you select the correct employing/host organisation from the Type of Cost drop down menu as this impacts the level of funding provided. Staff employed by a HEI are funded at 80% of cost, and staff employed by NHS, Commercial or Other Partner Organisations at up to 100% of cost. HEIs HEIs should determine FEC of their research using the Transparent Approach to Costing (TRAC) methodology. For HEIs, up to 80% of FEC will be paid, provided that TRAC methodology has been used. NHS Organisations For applications where the contractor (employing host) is an NHS organisation, up to 100% of direct costs will be paid. Completing the finance section All costs must be provided at current prices; an adjustment for inflation will be made annually thereafter at rates set by the Department of Health. Whilst allowances for incremental increases should be included on the form, nationally or locally agreed pay increases should be excluded. All applications are expected to have appropriate host organisation input into the finance section of the application form. Staff Current Salary and Proposed Salary Salaries in this section should be listed at 100%, even for those not working 100% WTE. i.e. this should be the full current staff cost independent of %WTE. This section presents an overview of salary costs for the Lead Applicant, including normal salary increments. Please state the current and proposed salary point and scale at the start of the fellowship. No additional increments should be included, and immediate promotion to a higher grade as a result of securing a fellowship will not be funded. Please do not include any Clinical Excellence or Discretion/Merit awards or discretionary points. NIHR agrees to fund consultant salaries at a full-time rate equivalent to 10 Programmed Activities per week. Fellowship Costs Salary Costs This section specifies the annual costs of the Lead Applicant. You should now allocate Lead Applicant costs to each year of the research, allowing for increments. Use current rates of pay, and build in any known annual increments (again at current rates). You will not be able to claim for increments retrospectively. Lead Applicant staff costs should be broken down into basic salary, National 15

16 Insurance, superannuation, and geographical weighting. A copy of the pay scales for the host institution must be uploaded in this section of the application. It is important to double check that the %, total months and yearly costs information are consistent with the information presented in the Proposed Salary, which should show the full current staff costs independent of % WTE, whereas the yearly costs in this section depend on % WTE. Training and Development All costs in this section will be met at 100% for HEI and NHS organisations. Please itemise and describe fully the costs associated with training and development. The CTF training programme: Please list the costs associated with supporting the fellow s clinical trial training activities (up to 5,000). HEI Indirect Costs Estates Charges & Other Indirect Costs Total HEI indirect costs must be fully justified. HEIs are permitted to claim estate and other indirect costs. These costs are calculated on the basis of TRAC methodology. Proposals from other types of institutions/organisations should leave this section blank. HEI indirect costs are based on the number of full-time equivalent research staff working on the research and the indirect/estates charges set by an institution. The applicant(s) should consult their HEI finance departments for the appropriate figures to include in the estate charges and other indirect cost sections. SUMMARY OF COSTS NIHR programmes currently fund: HEIs at a maximum of 80% FEC. NHS organisations at 100% of direct costs. Commercial/other partner organisations at 100% FEC. Please note that whilst these percentages will be used to calculate the maximum grant payable, the programme reserves the right to award a grant for less than this maximum where it is considered appropriate. Trainees and host institutions should note that by authorising and submitting an application they accept the process by which an application is assessed and agree to abide by the conditions under which an award may be offered. 16

17 Equal Opportunities and Diversity NIHR and DH have a duty as a public body to promote equality of opportunity. All applicants will be contacted shortly after the closing date by NIHR Equality Monitoring. Monitoring ensures that all applications to NIHR programmes are treated equally in terms of gender, ethnicity and/or disability. The information you share with the monitoring system: will be stored separately from your application; will only be used for the purpose of monitoring equal opportunities; and be kept securely and in confidence. If you do not wish to complete your details, this will not influence your application. NIHR Privacy Policy The privacy policy sets out how the NIHR uses and securely protects any information that you give us when you use this and other websites, systems and services of organisations that are contracted to the Department of Health to improve the health and wealth of the nation through research. The NIHR may change this policy from time to time. You may check the latest document content at any time by visiting the privacy policy page of the NIHR website at Enquiries If you have any queries about the scheme, please contact NIHR TCC: Telephone:

18 Signatory Flow Diagram 1. Application created by Lead Applicant 2. Lead Applicant adds Participants and Signatories details 3. Signatories log in and confirm their participation. This will be - Head of Department - Finance Officer Signatories complete 3. Lead Applicant continues entering data and completes all relevant sections of form 3. Participants log in and confirm their participation. This will be: - CTU Representative - Current Supervisor - Post Graduate Dean (if applicable) 3. Signatories complete relevant sections of form 3. Participants complete relevant sections of form 4. Lead Applicant Validates and presses the Submit button 5. Automated s sent to advise Signatories 6. Head of Department must log in and approve application* 6. Finance Officer must log in and approve application* 7. Application is fully submitted to NIHR TCC for consideration *Rejection of the application by any individual at Stage 6 will return the application to Stage 3. KEY Lead Applicant Participants Signatories Process 18

19 Further Guidance for Signatories and Participants The application must be completed in full, including signatories and participants, prior to the submission deadline. Please allow 1-2 weeks for the signatory approval process, do not wait to send the application to your signatories for approval on the closing date, as it may miss the deadline. Signatories These will be the Head of Department and the Finance Officer for the host organisation. Instructions for your roles are in the actions required by the Finance Officer and Head of Department section. Participant This will be the CTU Representative, Current Academic Supervisor and Postgraduate Dean (if applicable). Instructions for your roles are below. Actions required by the CTU Representative, Current Academic Supervisor and Postgraduate Dean (if applicable) Upon receipt of their , the Participant will be required to log in to their existing account/register on TCCi. Please check your Junk Mail folder if you haven t received the asking you to log in. Once logged in, you will need to click on My Co-applications. The next screen will show all outstanding participation confirmations. 19

20 Click on the Title and the option to confirm or reject participation in the application process will then be given as shown below. You can then confirm or reject your participation in the application. The CTU representative and Current Academic Supervisor will then be given an option to edit relevant sections of the application form that require their input. 20

21 Actions required by the Signatories (Finance Officer and Head of Department) Upon receipt of their , signatories will be required to log in to their existing account/register on TCCi. Please check your Junk Mail folder if you haven t received the asking you to log in. Once logged in, you need to click on My Approvals The next screen will show all outstanding participation confirmation and application approvals for that signatory. Click on the status (Confirmation Required). You will then be given the option to confirm or reject participation in the application process. 21

22 The signatory can then confirm or reject their participation in the application. For the Finance Officer only - Once participation has been confirmed, the Finance Officer will be able to edit the finance section of the application. This is done by clicking on the Edit button. 22

23 Actions for Signatories to approve application Signatories will be notified by when the Lead Applicant has submitted their completed application form for approval. When you receive this , please log back into TCCi and return to the My Approvals section, where you will see the following screen: Click on Awaiting Signatory Approval and you will be taken to the following screen: Signatories can view a PDF of the application form via the View/Print option and approve or reject the application. If the signatory chooses to reject the application then this will return the application to the presubmission process. This will mean the Lead Applicant must submit the application again for signatory approval If the signatory chooses to approve the application, then they will be taken to the following screen overleaf: 23

24 Please complete all sections and click Approve. You will then see the following message: Your status will change to the following: This indicates that the signatory has completed everything that is required of them. When the final signatory has completed their approval, the application is complete and has been submitted to NIHR TCC and the application status will change to Submitted. Please allow plenty of time for completion of the form, before the deadline on Thursday 24 August

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