2014 CTF R3 Guidance Notes - National Institute for Health

NIHR CLINICAL TRIALS FELLOWSHIPS
NIHR CLINICAL TRIALS FELLOWSHIPS 2014
GUIDANCE NOTES
Published April 2014
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Trainees Coordinating Centre
Introduction
On behalf of the National Institute for Health Research (NIHR), the NIHR Trainees
Coordinating Centre (TCC) is launching the third round of NIHR Clinical Trials
Fellowships.
The NIHR through its various national research programmes (www.nihr.ac.uk),
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 Clinical Trials Fellowship complete an application.
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:

Currently hold one of the following awards:
 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;
 NIHR Clinical Academic Training Doctoral Research Fellowship (CAT
DRF);
 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;

Have an award that finishes on or after 1st February 2015; and

Have continued support from their employing organisation for the duration of
the fellowship (this will be the host institution that administers their current
award and may or may not be the same as the institution that hosts the CTU).
Clinical Lecturers must also have permission from their Postgraduate Dean for time
out of their training programme.
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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, supporting
different trainees.
Scope
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 NIHR 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).
We expect 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
£5000 for each award). “Full Economic Costs” (FEC) will also be paid to Higher
Education Institutions.
It is anticipated that up to 6 fellowships will be awarded.
The CTF is additional to the trainee’s existing NIHR training award and must be
taken immediately after their current award finishes without a break in funding.
Funding for the Fellows will begin once details (including start date) have been
submitted to the NIHR TCC. Fellows should start within 18 months of awards being
announced, subject to the CTU having continuing NIHR CTU Support Funding in
place for the duration of the fellowship.
Management
Successful Fellows are expected to submit a progress report at the end of the
fellowship. The host organisation should submit a financial reconciliation following
completion of the award.
Selection Process for Applications

All CTUs in receipt of NIHR CTU Support Funding will be contacted and
asked if they are interested in participating in the round.

Details of participating CTUs will be available on the NIHR TCC website.
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
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 5th May 2014, stating their name and contact details, their current
NIHR award and projected end date, and summary of their trials exposure to
date and reasons for applying.

Applications will be reviewed and scored by an Expert Panel which will make
recommendations to the Director General of R&D for the Department of
Health.

The selection process and subsequent management of the NIHR CT
Fellowship will be managed by the NIHR TCC.

The outcome will be announced during Autumn 2014.
Assessment Criteria
Applications for 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; and

The extent to which the Fellowship will support professional and personal
development.
Completing the Application
Using the Electronic Application Form

All the application forms are ‘protected’. This means that you will only be able
to type in the appropriate boxes using the prescribed format. The size of each
section is fixed; be aware that visible text is limited to the size of the sections.
Please do not use a font size of less than 10 points for your application.

Other features, such as spelling and grammar checking are not available: you
may wish to prepare answers in a blank document and cut and paste them
into the application form when they are complete.

On opening the forms, the text fields will be highlighted. Type the appropriate
details and use the TAB key or mouse to move to the next available field.

The default format for entry of dates is dd/mm/yy
The application form is made up of a number of different parts, summarised below:

Part A
Application Summary

Part B
Trainee Curriculum Vitae

Part C
Trainee Experience and Case for Support

Part D
Hosting Organisation(s)
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
Part E
Justification of Resources Requested

Part F
Declarations and Signatures

Part G Department of Health Monitoring

Part H
Finance Form

Part I
Equal Opportunities Monitoring Form
The application form is available from the NIHR TCC website:
http://www.nihrtcc.nhs.uk/nihrclinicaltrialsfellowships/
It may also be requested as a Word document by e-mailing:
[email protected]
Part A – Application Summary
Trainee Details

Please enter your full name.

For doctors and dentists, please enter the GMC-/GDC-recognised specialty.
For all other applicants, please enter your discipline or professional
background from the dropdown menu.

Please add your professional body registration membership and registration
number where appropriate.

Please select your current NIHR training award from the dropdown menu.

Please select your proposed start date from the dropdown menu.
Clinical Trials Unit Details

Please give details of the Clinical Trials Unit where the fellowship will be
based, details of your current appointment and details of the employing
organisation where this is different.
Part B – Trainee Curriculum Vitae

Please enter your employment history with your most recent position first.

Please enter your professional qualifications, educational qualifications,
degrees and diplomas.

Please provide details of all NIHR or other grants or awards that you currently
hold or have previously held. This should also include any NIHR training
fellowships.

Please list all recent publications that would be of relevance to this
application.
Part C – Trainee Experience and Case for Support
Summary of Experience

Within this section 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.
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Overview of Training and Future Plans and Career Intentions

Please indicate how this training will build on your existing experience and
outline your future research and career intentions. In what ways will this
additional training add value to your career?
Part D – Hosting Organisation(s)
This section should be completed by the CTU and employing organisation where this
is different.
Contact Details

Please provide contact details for the senior representatives of the
organisation(s).
CTU Proposed Training Programme

Please provide a clear outline of the of the 6 month training programme. The
training should provide ‘hands on’ experience for all stages for 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.
Training Supervision

Please give details of the 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.
Part E – Justification of Resources Requested

This section provides the rationale behind the request for resources. The
section is free text and will expand as required. Please refer to the specialist
finance Guidance Notes (Part H) for limits on funding. You are advised to
read these carefully to inform the completion of this section.

Please provide a breakdown of costs associated with undertaking this
Fellowship and provide justification for the resources requested.

You should describe the value for money of the work itself
Part F – Declarations and Signatures
All parties must read carefully the declarations and signatures section.
The Trainee
The trainee should sign the NIHR CTF Application Form to confirm that:

The information provided in the application is true, accurate and complete;

They understand the terms and conditions of an NIHR CTF; and

If successful, they will undertake the work according to good practice.
NIHR Carbon Emissions Guidelines

Please tick the box to confirm that the applicant has read the NIHR Carbon
Reduction Guidelines and, where possible, taken steps to reduce the carbon
emissions generated by this research.
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Trainees Coordinating Centre

Advice on how to do this can be obtained from the NIHR Carbon Reduction
Guidelines:
http://www.nihr.ac.uk/publications/Pages/carbon_reduction_guidelines.aspx
The Lead Employing Institution
All applications should be signed by the appropriate administrative authority (e.g. the
institution's finance officer) and the Head of Department of the prospective host
institution.
In signing, the officials are indicating:

Their approval of the application;

Their willingness to offer an appointment to the individual (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; and

Their acceptance of the terms and conditions associated with an NIHR CTF.
The Clinical Trials Unit

A representative of the Clinical Trials Unit must sign off the application.
Part F(i) – Current supervisor’s statement of support

All applications should include a statement of support from the trainee’s
current academic supervisor.
Part F(ii) – Postgraduate Dean’s Statement

All applicants who are undertaking specialty or general practice training are
required to submit part F(ii), completed by their current Postgraduate Dean.
Part G - Department of Health Monitoring Information

Please use the drop-down menus and tick boxes to provide the information
requested. This will be used solely by the Department of Health and the NIHR
for accountability, audit and monitoring purposes.
Classification of Proposed Research

The research classifications contained in this section are those developed by
the UK Clinical Research Collaboration (UKCRC) to classify and analyse
health research.
Health Category

You should choose one health category from the list to classify the NIHR
research on which your work is based.

If this 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: http://www.hrcsonline.net/
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Research Activity

You should choose one research activity from the lists to classify the NIHR
research on which your work is based.

If your proposed research area 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
http://www.hrcsonline.net/
in the downloadable Health Research
Classification System booklet.
Part H - Finance
The finance form should provide a breakdown of costs associated with undertaking
the Fellowship as described in the proposal.
General Information

NIHR Clinical Trials Fellowships 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).

Funding is provided to cover the trainee’s salary costs and a contribution to
support the clinical trial training activities (up to £5,000) only.

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.
Details of Proposed Fellowship
Please complete:

Clinical Trials Unit.

Applicant name.

Start date (please note NIHR TCC awards may only start on the first of the
month).

Select % WTE from drop down menu.

Duration (months).
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Information on different types of employing organisations

Please select the employing/host organisation type from the drop down menu.
Please ensure that you select the correct employing/host organisation as this
impacts on the level of funding provided.

Staff employed by a Higher Education Institution (HEI) are funded at 80% of
cost, and staff employed by NHS, Commercial or Other Partner Organisations
at up to 100% of cost.

Applications are invited from current NIHR trainees (NIHR DRFs, NIHR PDFs,
NIHR CLs or NIHR Clinician Scientists) working in any scientific discipline or
sector, within an institution sited in England, who are currently involved in
clinical trials as part of their training award and will benefit from hands on
experience and training in all aspects of clinical trials.

NIHR TCC would normally expect applicants to indicate that they intended to
be employed by an English NHS or other healthcare organisation or a
recognised English HEI.
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.
A. DIRECT COSTS
These are costs that are specific to the research, which will be charged as the
amount actually spent and can be supported by an audit record. They should
comprise:
A1: Staff
Details of Posts and Salaries. Salaries should be listed at 100%. This section
presents an overview of salary costs needed to support this fellowship. Please list:
The applicant
 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.
Annual Costs of Posts

This section specifies the annual costs of the applicant and support/shared
staff contributing to the research.

You should now allocate the individual staff member costs to each year of the
research, allowing for increments.
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
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, once your
research is underway.

Applicant staff costs should be broken down into basic salary, national
insurance, superannuation and geographical weighting.

Please note the ‘% full time on this research’ and the ‘Year’ columns are
independent and the % figure is not used to calculate the net staff costs.

For the ‘Year’ columns, enter the cost of
research/fellowship.
the individual to the
For example:


If an individual’s total annual salary costs are £20,000 and they are
expected to work 50% of the time on the research/fellowship, in the
‘% full-time on this fellowship’ column enter 50, then £10,000 in
‘Year 1’, £10,000 plus any increment in ‘Year 2’, £10,000 plus any
increments in ‘Year 3’, etc.

If an individual is going to work full-time on the research/fellowship,
for 6 months, enter 100 in the ‘% full-time on this fellowship’ column
and 6 in ‘total months on this research’ column, and the cost of their
work in the ‘Year 1’ column.
It is important to double check that the %, total months and yearly costs
information are consistent with the information presented in ‘Details of Posts
and Salaries’ (‘Details of Posts and Salaries’ should show the full current staff
costs independent of % FTE etc, whereas the yearly costs in ‘Annual Costs of
Posts’ depend on % FTE etc).
A2: 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).
B: HEI Indirect Costs
B1: Estates Charges & B2: 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.
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C: SUMMARY OF COSTS


NIHR programmes currently fund:

HEIs at a maximum of 80% FEC;

NHS organisations at 100% of direct costs; and

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.
Submitting the Application

One original application form Parts A to G with signatures and one original
copy of the Finance form Part H

A CD or memory stick containing the completed application form and finance
form Parts A to H.

One original copy of the equal Opportunities Form Part I.

Please ensure your completed application is securely packaged for delivery.
Incomplete or damaged applications will not be accepted.

Please do not submit any additional papers.
Completed applications should be sent to:
NIHR Clinical Trials Fellowships
NIHR Trainees Coordinating Centre
Leeds Innovation Centre
103 Clarendon Road
Leeds
LS2 9DF
Closing Date 17:00 Wednesday 25th June 2014

Incomplete, faxed or emailed applications will not be accepted.

Proof of postage will not be accepted as proof of receipt by the published
closing date and time.

Late applications will not be considered under any circumstances.

You are advised to use a guaranteed delivery service when posting your
application; however, please note that it remains your responsibility to ensure
your application is received by the published deadline.
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Acknowledgement
Applications will be acknowledged by email within a week of the closing date and
time. Applicants should not phone or email the NIHR TCC offices with enquiries prior
to receiving this email.
Data Protection Act
The Data Protection Act 1998 gives individuals the right to see personal information
held about them on computer and in some paper files. NIHR TCC complies with the
requirements of the Data Protection Act with regard to the collection, storage,
processing and disclosure of personal information.
Freedom of Information and Transparency
NIHR TCC manages the NIHR Fellowships Programme on behalf of the Department
of Health. As such, the findings of researchers funded by the programme are
incorporated into the DH Freedom of Information Publication Scheme:
https://www.gov.uk/government/organisations/department-ofhealth/about/publication-scheme
Government procurement transparency regulations require us to publish details of all
contracts made with the Department of Health on the Department of Health Website.
Confidential information including bank details, staff names and Heads of
Department names will be removed from the published versions.
Guidance and Advice
If you require any further information, advice and guidance please contact:
NIHR Trainees Coordinating Centre
Leeds Innovation Centre
103 Clarendon Road
Leeds
LS2 9DF
Tel.
0113 346 6260
Email.
[email protected]
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