Key Dates & Times: Call opens 04 August 2020 Virtual Q&A October 2020 Application Closing Date 13:00, 15 January 2021 Cancer trials in Ireland 2021 Guidance Notes Applications must be completed and submitted through the HRB online Grant E-Management System (GEMS) (https://grants.hrb.ie), and this system will close automatically at the stated deadline and timeline listed above. Applicants are strongly advised to read the ‘Detailed guidance notes for applicants’ appended to this document prior to completing the application forms.
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Key Dates & Times:
Call opens 04 August 2020 Virtual Q&A October 2020 Application Closing Date 13:00, 15 January 2021
Cancer trials in Ireland 2021
Guidance Notes
Applications must be completed and submitted through the HRB online Grant E-Management System (GEMS) (https://grants.hrb.ie), and this system will close automatically at the stated deadline and
timeline listed above. Applicants are strongly advised to read the ‘Detailed guidance notes for applicants’ appended to this document prior to completing the application forms.
4 HRB Oversight and monitoring .............................................................................................................................. 9
5 Funding and Duration of Awards ......................................................................................................................... 10
8 Trial Registration and Reporting .......................................................................................................................... 16
9 FAIR Data Management and Stewardship ........................................................................................................... 17
10 Public and Patient Involvement (PPI) in research .......................................................................................... 17
11 General Data Protection Regulation ............................................................................................................... 18
12 Application, Review Process and Assessment Criteria ................................................................................... 19
13 Conflict of Interest .......................................................................................................................................... 21
The overall goal of the new funding model for HRBs investment in cancer trials in Ireland is to support
an appropriate infrastructure; enabling Irish patients to access a diverse portfolio of high-quality, safe
and compliant cancer clinical trials in Ireland.
In order to achieve this goal, essential features of the funding call include:
• a more efficient, coordinated and focused infrastructure that enables greater access to specific
expertise for the design and development, efficient and timely activation, conduct, completion
and reporting of cancer clinical trials, meeting all regulatory requirements,
• strengthened scientific excellence in cancer clinical trials by continuing to network and integrate at a national level, the critical mass of expertise and resources needed to provide Irish leadership in investigator-led and commercial cancer clinical trials,
• a more strategic approach to the portfolio of cancer clinical trials in Ireland developed or adopted within the “Clusters”,
• Strengthening of existing partnerships between the hospital sites, clinical research facilities/centres and academic partners of each cluster, to enhance governance, advance cancer clinical trials and provide appropriate incentives for clinicians to engage in cancer clinical trials,
• a more integrated and embedded system of cancer clinical research activity within the HSE/NCCP, as measured through leveraged support from the HSE/NCCP. Co-investment will be required in the form of support for core staff and/or in-kind contributions towards the operation of the clusters, which will need to be verifiable under accounting standards,
• greater transparency in all financial and governance matters related to trial activity; ensuring that the appropriate financial and underpinning governance measures are in place,
• increased number of high-quality cancer clinical trials (investigator and industry-led) in Ireland that lead to improvements in patient outcomes and/or clinical care, as measured through a formal assurance framework with clear metrics, and
• embedding patient and public involvement in all cancer clinical trials.
The investment will potentially support between 5-7 cancer delivery Clusters (one in Paediatrics) aligned with the Hospital Groups and a national Cancer Clinical Trials Network.
3 Scope
Investments are intended to build on positive achievements of our previous investment in cancer clinical
trials and other clinical trials infrastructures. Activities must complement and coordinate with other
national clinical trials infrastructure investments.
This award will provide HRB funding of up to a maximum of €21 million (inclusive of overheads) over a
five year period for the establishment of cancer trial delivery Clusters and a national Cancer Clinical
Trials Network to support cancer clinical trials in Ireland.
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3.1 Cancer trial delivery “Clusters”
The existing 11 HRB-funded cancer trial units at various hospital sites are invited by the HRB to
assemble as a “Cluster”, in partnership with each other or alone, aligned to the hospital group
delineation.
Our Lady’s Children’s Hospital Crumlin (OLCHC), soon to become Children’s Health Ireland, are issued a
specific invitation to apply as a Cluster for Paediatrics. A portion of funds is ringfenced for this purpose,
including resources to cover the governance activities currently carried out at OLHC.
Radiation oncology was highlighted, in the feedback from the oncology research community, as a
specific clinical speciality that necessitates acting as a stand-alone Cluster, separate to the medical
oncology Clusters. In this case, the HRB expect a single application for a Radiation Oncology Cluster and
that the case for a separate Cluster with national reach for cancer patients is articulated in the
application.
All applications for a Cluster must be submitted on behalf of each Hospital Group, aligned to one of the
seven named Clinical Research Facility/Centres (CRF/C’s) in Ireland (see section 5.1 for further details),
with applications being submitted through the associated HRB Host Institution (Academic partner).
Into the future, it is envisaged that support for Cancer Clusters will be merged into the HRB’s funding
support for Clinical Research Facilities as a specific cancer arm of the Clinical Research Facility, quality
permitting. This will ensure economies of scale, will avoid duplication and ensure continued consistent
governance for the conduct of safe and high-quality cancer clinical trials. The current model is designed
to enable this change in an incremental fashion.
Cluster applications must be made in partnership with a selected Cancer Clinical Lead and CRF/C
Director, with support from both the lead Hospital or Hospital Group CEO and a University Partner.
The HRB will contract directly with the nominated academic partner of each Cluster.
Clusters will be expected to:
• Partner with an academic host institution and local Clinical Research Facility/Centre based on
hospital group delineation
• Demonstrate a level of co-investment from the HSE/NCCP or other combination that is verifiable
in accounting terms
• Show a degree of strategic alignment with the regional integrated care organisations
• Demonstrate a previous track record of working together to develop and successfully deliver
cancer clinical trials over the previous funding period (2017-2020)
• Contribute to partnerships with Collaborative groups, Charities and Industry, as appropriate to
the portfolio
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• Provide expertise in the design, development, conduct and delivery of a portfolio of high-quality
clinical trials,
• Deliver a portfolio of trials within and or across the Clusters, supported by a well-functioning
referral system, to provide equitable access for all cancer patients to high quality cancer trials
• Deliver high-quality regulated and un-regulated trials, working closely with the Cancer Clinical
Trial Network as appropriate
• Avail of other clinical trial infrastructure supports (HRB-funded or otherwise) – e.g. clinical
research facilities/centres, HRB-Trial Methodology Research Network, new PPI Network etc.
• Use a centralised data management system, such as ‘CRF Manager’, aligned with other clinical
research infrastructures, for trial management and reporting
• Report all metrics as required by the HRB as a prerequisite for continued funding
• Train, educate and support all personnel working on clinical trials in the cluster aligned with
supports within existing clinical trials infrastructures.
3.2 National Cancer Clinical Trials Network
The scheme will provide support for an appropriate entity with a previous track record of providing
clinical trial services and supports to act as the national Cancer Clinical Trials Network, to provide
sponsorship oversight, support services and networking activities to the approved Clusters.
Applications for a national Cancer Clinical Trials Network must be submitted on behalf of a nominated
national Cancer Clinical Lead with the support of a recognised HRB Host Institution.
A National Cancer Clinical Trials Network will be expected to:
• Partner with an academic host institution
• Provide Governance support as Sponsor for the conduct of multicentre regulated cancer clinical
trials
• Provide Support services for studies including project management, database design and build,
clinical trial data management, data analysis, statistical analysis plans and reports, monitoring,
reporting and administration of trial activity at each approved cluster where required. They will
also be mandated to report on trial delivery and performance.
• Provide Networking support for Clusters to;
o Network and integrate at a national level the critical mass of expertise and resources
needed to provide Irish leadership in Investigator-led and commercial cancer clinical
trials
o Pro-actively establish and grow partnerships with Collaborative groups, Charities and
Industry, as appropriate to the portfolio of cancer trials
o Design and develop a portfolio of high-quality cancer clinical trials
o Ensure policies on the:
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▪ study selection and prioritisation for the network as a whole
▪ peer review of clinical trials which do not come with external competitive
funding e.g. commercial trials
▪ procedure and criteria for stopping trials within the cancer portfolio that is
maintained and implemented
▪ management of contributions from industry collaborators including a charging
model/list of fees for commercial studies
o Embed public and patient involvement in all cancer clinical trials
o Provide network support to all trial delivery teams at sites by providing a
communication platform for all members e.g. development of a community of practice.
3.3 Relationship with other clinical trials infrastructures
As we enter a new phase of investment in national clinical trials infrastructure, it is critical that
coordination and synergies are enhanced across the system to maximise the value of this investment.
Cancer trials infrastructures are expected to work with other clinical trials infrastructures within the
system to collectively improve patient access to clinical trials, integrate relevant best practices where
necessary to support national performance for the benefit of the Irish clinical trials system. These
include Clinical Research Facilities/Centres, Trials Methodology Research Network and the National
Clinical Trials Coordination Programme.
The National Clinical Trials Coordination Programme is expected to provide streamlined processes for
the conduct of multicentre clinical trials, such as the national feasibility programme, which is dependent
on local resources within other clinical trials infrastructures.
Dedicated resources will be supported through this call to work with, and contribute to, the National
Clinical Trials Coordination Programme. These personnel provide an underpinning link between the
clinical trials infrastructures and the National Clinical Trials Coordination Programme. They are
responsible for providing local data and information from the clinical trials infrastructure to the National
Clinical Trials Coordination Programme and for leading local implementation of measures to support
national alignment.
HRB expectations will be underpinned through special contractual conditions in relevant grant contracts
and will be a core element in ongoing assessment of grant performance of any subsequent award.
Applicants will have to set out how they propose to engage clinical trials infrastructures, and what plans
they have for the term of the award. Letters of Support/Infrastructure Agreement Forms from the
relevant clinical trials infrastructure will need to be provided at time of application clarifying how the
programme will engage with them for the term of the award.
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HRBs investment through this specific instrument will not support;
• funding for individual cancer clinical trials as it is expected that trials should come with
competitive funding from sources with effective independent international peer review, such as
the HRB Definitive Interventions and Feasibility Awards, other national/international funding
sources, international collaborative groups and / or industry-funded studies
• costs associated with routine patient care or translational studies, biobanks, patient registries
and questionnaires
• establishing new premises, including building work, or fit-out of buildings.
4 HRB Oversight and monitoring
4.1 HRB Clinical Trials Infrastructure Expert Advisory Group For independent oversight and strategic leadership, the HRB will appoint a Clinical Trials Infrastructure
Expert Advisory Group to oversee our investments in Clinical Trials Infrastructure from 2021 onwards.
The Expert Advisory Group will be established to help guide the HRB and the clinical trials community to:
• work towards integrating clinical trials within the health system to ensure that they are
delivered as part of usual care,
• raise the standards of the clinical trials environment and their conduct in Ireland whilst, and
• safeguarding the HRB’s investment of approximately €60 million in Clinical Trials Infrastructure
over the next five years.
The Expert Advisory Group will work with the HRB to review performance of all clinical trials
infrastructures on an ongoing basis and will be instrumental in implementing corrective action where
needed.
4.2 Award monitoring
Mandatory metrics will be established for the successful awards which will be used by HRB to monitor
progress. These key metrics will be agreed with the HRB prior to issue of award contract and aligned
with the HRB Clinical Research Facility/Centre and Clinical Trial Network funding calls. Clear reporting of
metrics will be a pre-requisite for continued funding, which will be monitored on an annual basis and
evaluated at an interim point. Mandatory metrics will include information about e.g. the number and
type of clinical trials, study start up, registration, recruitment levels - time to target vs. global
recruitment, reporting, networking activity, supports provided to the Clusters, changes to clinical
guidelines/practice, research articles, educational resources, reports, policy briefs and other relevant
documents.
Awardees will have to report on activity as part of the national feasibility programme of the National
Clinical Trials Coordination Programme as required. This will form part of the contractual obligations to
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the HRB. Awardees will also be expected to report activity in relation to participation in or leadership of
National Clinical Trials Coordination Programme Working Groups, and adoption of the outputs.
Furthermore, awardees will be expected to report activity in relation to work with other clinical trial
infrastructures, including HRB-TMRN, HRB-funded clinical trials networks, and the National PPI Network.
5 Funding and Duration of Awards
5.1 HRB Funding
Total HRB funding for this call will be up to a maximum of €4,175,000 per annum inclusive of overheads
over five years. The overhead contribution is aligned to research activity per application and aligns with
that paid to other HRB infrastructures;
• 30% overhead contribution for Cluster applications (in line with CRFs), and
• 25% overhead contribution for the National Cancer Clinical Trial Network application (in line
with other CTNs).
The funding split between the two calls is 65:35. With 65% of the overall funding going towards Cluster
applications and 35% going towards the National Cancer Clinical Trial Network.
The duration of the awards will be 60 months with an interim review.
5.1.1 Cluster funding
Total HRB funding will be up to a maximum of €2,713,750 per annum inclusive of overheads for all the
Cluster applications (including the Paediatric Cluster). The funding envelope per Cluster will vary
depending on the hospital group delineation (i.e. the number of hospital partners involved) and
previous performance. Therefore, awards will range between €150k to €500k p.a. over five years.
A portion of funds, approximately €500K per annum, is ringfenced for the Paediatric Cluster, which
includes resources to cover the governance activities currently carried out at OLHC.
It is recognised that Clusters scale, structure and levels of activity will differ therefore different levels of
investment are expected. Requests for support should be closely aligned with evidence of previous
performance and future plans. Budgets will be set out in a modular fashion, and it is possible that the
International Expert Panel will recommend funding for some modules but not others.
There will be a maximum of between 5 and 7 clusters, depending on budget available and quality of
applications.
The award will predominantly offer support for operational costs such as salary for core staff members
within the cancer delivery units, for example a Programme manager (Cluster manager), clinical trial
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nurses and data managers. As applications are made in partnership between the Hospital Group or
Hospital and University partner, most appointments are expected to be supported through Health
Service Executive contracts. However, applications are encouraged to consider a number of joint
appointments for Principal Investigators and core staff such as clinical research nurses to enable greater
integration of clinical research into the health system.
Eligible running costs include but are not limited to attendance at training events and centralised data
management systems, such as ‘CRF Manager’.
Co-investment for Clusters is a requirement of this call. Co-investment is required in the form of
support for core staff and/or in-kind contributions towards the operation of the Clusters, which will
need to be verifiable under accounting standards. Cluster applications must show evidence of co-
investment from academic, hospital and / or other partners. A matched funding ratio of 2:1 (HRB:
Partners) is expected i.e. for every €2 HRB investment a minimum co-investment of €1 from academic
partner, hospital group, individual hospital or other partner is required for the duration of the award.
We expect the following:
• between five to seven awards, budget and quality permitting,
• HRB funding cannot displace existing hospital funding; this existing investment should be
captured as co-investment,
• a minimum level of co-investment of 2:1 (HRB: Partners),
• clusters with lower levels of trial activity (based on registered clinical trials between 2017 and
2019) will be expected to bid for lesser amounts,
• all clinical trials infrastructures receiving funding from the HRB will be expected to support and
contribute to, the National Clinical Trials Coordination Programme and resources should be
assigned for that purpose, and
• awards will commence in January 2022 for a period of five years with continued funding based
on performance to agreed metrics over that funding period.
Funding will be awarded on a claims-made basis. Should the budget allocation for a period not be
claimed in full, the balance cannot be carried over and will be lost to the award (+/- 10% rule will be
applied). Therefore, it is important when developing the budget that applicants plan carefully in order to
draw down of the full amount awarded.
5.1.2 National Cancer Clinical Trial Network funding This award will run over 60 months and the maximum amount available will be €1,461,250 per annum
(inclusive of 25% overheads).
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Funding for sponsorship, support services and network activity are allowed, to drive a coherent network
and integrate at a national level, the critical mass of expertise and resources needed to provide Irish
leadership in Investigator-led and commercial cancer clinical trials.
The award will predominantly offer support for operational costs such as, but not limited to salary for
• core staff in database design and build, clinical trial data management, data analysis, statistical
analysis, monitoring etc.
• administration support and project management support for the central function, and / or
• clinical lead buy-out time to strategically lead the Network (maximum salary contribution of
€100K per annum).
Eligible running costs include but are not limited to a communication platform for all members, travel,
meeting costs and networking events.
We expect the following:
• one award will be made, quality permitting,
• Published process for access to supports, with clear assessment criteria, and clear cut-off dates
for access to supports where applicable.
• Published process for study selection and prioritisation for the network as a whole
• Published process for peer review of any studies which do not come with external competitive
funding.
• Policy on the procedure and criteria for stopping trials.
• Charging model/list of fees provided for industry studies
• all clinical trials infrastructures receiving funding from the HRB will be expected to support and
contribute to, the National Clinical Trials Coordination Programme and resources should be
assigned for that purpose, and
• award will commence in January 2022 for a period of five years with continued funding based on
performance to agreed metrics over that funding period.
6 Eligibility
6.1 Cluster(s) Application
Applications must be made on behalf of a team which is made up of a selected Cancer Clinical Lead,
CRF/C Director and Site Leads from each of the associated hospital sites, and submitted through a HRB
Host Institution5 on behalf of a Hospital Group aligned to one of the seven below-named Clinical
Research Facility/Centres (CRF/C’s) in Ireland.
5 The Host Institution (HI) for the HRB award must be a HRB recognised host institution. It is normally that of the
Lead Applicant, but it may be another organisation/institution designated by the applicant team, where it is clearly
justified. An up to date list of HRB recognised host institutions can be found at all times at:
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The seven named CRF/Cs and associated academic partners are;
1. Wellcome Trust-HRB-CRF at St. James Hospital in Dublin (hosted by Trinity College Dublin)
2. HRB-CRF Cork at the Mercy Hospital and Cork University Hospital (hosted by University
College Dublin)
3. HRB-CRF Galway at University College Hospital Galway (hosted by the National University of
Ireland Galway)
4. University College Dublin CRCs at The Mater Misericordiae University Hospital and St
Vincent’s University Hospital (hosted by University College Dublin)
5. Royal College of Surgeons in Ireland CRC at Beaumont Hospital (hosted by Royal College of
Surgeons in Ireland)
6. The Health Research Institute Clinical Research Support Unit at Limerick University Hospital
(hosted by University of Limerick)
7. Children’s Health Ireland (various hosting partners).
The applicant team should consist of Co-Lead Applicants, a Cancer Clinical Lead and a CRF/C Director,
and Co-Applicants (Site Leads) from each of the associated hospital sites within the application.
The Cancer Clinical Lead will serve as the primary point of contact for the HRB during the review process
and the duration of any subsequent contract. If successful, they will have overall responsibility for
delivery of the objectives of the Cluster and primary fiduciary responsibility and accountability for
carrying out the cluster activities within the funding limits awarded and in accordance with the terms
and conditions of the HRB. The division of responsibilities between the Co-Leads and Site Leads should
be clearly outlined within the application.
The Co-Lead Applicant(s) must:
• Hold a post (permanent or a contract that covers the duration of the award) in a HRB recognised
Host Institution in the Republic of Ireland (the “Host Institution”) as an independent
investigator. For clinicians, an adjunct position in a HRB recognised Host Institution is
acceptable, OR
• Be an individual who will be recognised by the Host Institution upon receipt of an award as an
independent investigator who will have a dedicated office and research space for the duration
of award, for which he/she will be fully responsible. The Co-Lead Applicant does not necessarily
need to be employed by the Host Institution at the time of the application submission.
The Site Leads as Co-Applicants have a well-defined, critical and substantial role in terms of assisting the
Co-Lead Applicants with the leadership and management of the proposed Cluster. Site Leads are
Data management/stewardship plans (DMP) are nowadays widely accepted as part of good research
practice. The HRB supports open research7 and open publishing directly through the HRB Open
Research Platform8. The HRB are driving the making of research data FAIR (Findable, Accessible,
Interoperable and Re-usable) in order to benefit science by increasing the re-use of data and by
promoting transparency and accountability. The FAIR data principles9 provide a guideline for those
wishing to enhance the re-usability of their data holdings: these principles put specific emphasis on
enhancing the ability of machines to automatically find and use the data, in addition to supporting its re-
use by individuals.
For researchers, the move to FAIR and open data means researchers should consider data management
issues and identify suitable data repositories at the research planning stage. Applicants will have to
provide information about their plans for data management and data sharing at application stage.
10 Public and Patient Involvement (PPI) in research The HRB Strategy 2016-2020, Research. Evidence. Action., refers to Public and Patient Involvement (PPI)
as a core principle of research and contains the commitment to strengthen and develop PPI within the
HRB and in HRB-supported projects and programmes. The HRB is the first public funding agency in
Ireland to do so. The development of the next HRB Strategy 2021-2030 is progressing and putting the
public at the heart of the research that the HRB funds is emerging as a key theme.
The HRB is using the definition of PPI proposed by INVOLVE: Research carried out ‘with’ or ‘by’ members
of the public rather than ‘to’, ‘about’ or ‘for’ them. The HRB promotes the active involvement of
members of the public in the research that we fund10. Public involvement is distinct from and additional
to activities that raise awareness, share knowledge and create a dialogue with the public and it is also
distinct from recruitment of patients/members of the public as participants in research.
'Public involvement' represents an active partnership between members of the public and researchers in
the research process. This can include, for example, involvement in the choice of research topics,
assisting in the design, advising on the research project or in carrying out the research.
PPI contributors should be actively involved and part of decision making. Involving members of the
public in research can improve quality and relevance of research. It can:
• provide a different perspective - even if you are an expert in your field, your knowledge and
experience will be different to the experience of someone who is using the service or living with
a health condition,
• make the language and content of information such as questionnaires and information leaflets
clear and accessible,
• help to ensure that the methods proposed for the study are acceptable and sensitive to the
situations of potential research participants,
• help to ensure that the research uses outcomes that are important to the public,
• identify a wider set of research topics than if health or social care professionals had worked
alone, and
• help you increase participation in your research by making it more acceptable to potential
participants.
In addition to improving relevance and quality of research, it ensures that research is influenced by
broader principles of citizenship, accountability and transparency. PPI is an ethos as well as a practice. It
should be context-specific and should aim to ensure that all voices are heard. Where members of the
public or patients are involved, they must be compensated for their time and contributions.
During 2020, the HRB together with the Irish Research Council invited an application for a National PPI
Network, with local sites across Ireland. The new National PPI Network will be awarded in March 2021.
In the application, you are asked to describe how your clinical trials infrastructure will support
researchers’ PPI activities during the development of an application and during the conduct of a cancer
clinical trial.
PPI should play a critical role in cancer clinical trials. If there is currently no PPI strategy within the
national Cancer Clinical Trial Network this is an opportunity to develop an approach to embed PPI within
the work of the national network.
11 General Data Protection Regulation
The General Data Protection Regulation (GDPR) came into force on 25 May 2018. As a result, the
applicant teams will be asked through the HRB Grant E-Management System (GEMS) to consent that
personal data provided as part of this application, including but not limited to CV information, may be
shared with person(s) based outside of the European Economic Area (EEA) for the specific purpose of
obtaining panel reviews of this application. International reviewers play a vital role for the HRB in setting
standards and in benchmarking our scientific community to enable them to operate in a global context.
Panel reviewers are selected for their specific expertise in relation to submitted application and can be
based anywhere in the world.
Furthermore, by confirming participation, you will be asked to consent that the HRB uses the
information you provide (regarding all applicant team members) to consider your application, contact
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you about your application, and if you are successful, to manage your grant throughout its lifetime in
accordance with general T&C for research awards. This will include contacting you with regard to
monitoring of progress through written reporting and other means e.g. interim review. We will publish
some basic information on successful awards including PI, Host Institution, amount awarded and lay
summary on our website and may highlight individual awards or researchers in more detail (with specific
consent). We will also use the information you have provided to generate general statistics around our
current funding portfolio, and to evaluate our funding mechanisms and investment. After your grant has
ended, we will continue to keep your information on file (in accordance with HRB policies) to allow us to
evaluate the outcomes, outputs and impacts of HRB investment in your research.
Please note that we will also use information associated with unsuccessful applications for a number of
the purposes outlined above such as generating general statistics around our current funding portfolio,
and to evaluate our funding mechanisms and investment e.g. demographics of applicants, research
areas of applicants. Similarly, we will use the information provided about people employed on awards to
help evaluate our career support and capacity building initiatives.
12 Application, Review Process and Assessment Criteria The HRB is committed to an open and transparent process underpinned by quality, excellence and international peer review. To ensure the integrity of the assessment process, conflict of interest and confidentiality are applied rigorously at each stage of the process.
12.1 Grant E-Management System (GEMS)
All applications must be completed and submitted through the HRB online Grant E-Management
System (GEMS) (https://grants.hrb.ie). GEMS will close automatically at 1pm on Friday 15 January
2021.
The applications must have been reviewed and approved by the signatory approver at the research
office (or equivalent) in the host institution before it is submitted to the HRB. Therefore, applicants
should ensure that they give the signatory approver enough time before the scheme closing date to
review the application and approve it on GEMS. Please note that many host institutions specify internal
deadlines for this procedure.
12.2 Gender Policy
The HRB Gender Policy came into effect on 1 June 201611. In line with international best practice the
HRB has a responsibility to support both women and men to realise their full potential in order to
ensure equality of opportunity and to maximise the quantity and the quality of research. To ensure
3.3 Management, Governance and Strategic Oversight
Provide a high-level description of the oversight, advisory or governance structures that will be put in
place for the Cluster. Please provide details about any reporting relationship with the HI/Hospital
Groups, Clinical Research Facility/Centre, and external governing bodies as appropriate. Include details
of Governance Board, Scientific Advisory Boards and any other committees as applicable, including the
scientific advisory groups of the national cancer clinical trial network (please detail
role/membership/frequency of meetings).
The Clusters and the National Cancer Clinical Trials Network are also expected to cooperate fully with
any HRB Clinical Trials Infrastructure Expert Advisory Group. This Expert Advisory Group is anticipated
to assist the HRB in the strategic oversight and performance monitoring of the Infrastructures,
networks and Interventions portfolio.
The word limit is 500 words.
3.3.1 Organogram (mandatory upload)
Please include an organisational chart/organogram to illustrate the Cluster structure, management and
governance using the file upload option on GEMS.
3.4 Operational model
Describe the operational model which supports the cancer clinical trial portfolio at your Cluster. Please
describe how the current operational model is appropriate to the stage and scale of the proposed
activities.
3.4.1 Key Policies and Processes
Briefly describe key policies and processes. Please include references to patient flow and population,
accessibility, referral system, inclusiveness and linkage to the national cancer clinical trial network for
study selection and supports to deliver high quality regulated and un-regulated cancer clinical trials.
The word limit is 1500 words.
In the context of the Paediatric Cluster application or applications associated with the Paediatric Cluster
– please describe how adolescent/young adults patient populations will be addressed.
The word limit is 250 words.
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You may embed links to key policies and SOPs.
A file upload option is available to include an attachment to support your operational model description.
A maximum of 8 figures, which can be a combination of images, graphs, tables, scales, instruments or
surveys, may be uploaded as a single document on HRB GEMS. They must not be embedded within the
text of the operational model description. The maximum size is 2MB.
3.5 Financial Management support for Cluster
Please provide details about the financial management processes to manage Cluster income and
expenditure. Please include information on accounts to be used, processes such as invoicing, and
processes to enable income and expenditure to be reported on an annual basis.
The word limit is 200 words.
3.6 Clinical Research Infrastructure Agreement Form (mandatory upload)
A Clinical Research Infrastructure Agreement Form must be completed for each Cluster and can be
downloaded from GEMS. The Form must be completed, signed, dated and uploaded on GEMS.
Electronic signatures are acceptable for letters/forms that are uploaded on GEMS.
4 Cluster Clinical Trial Performance to date
4.1 Registered clinical trials activity
Please list all registered cancer clinical trial activity at the Cluster from 1 Jan 2017 to 31 Dec 202013 from
earliest to most recent, in the accompanying Metrics Excel spreadsheet template. A full explanation of
terms is given in the “Clinical Trial Data Reference” document.
Please note that only registered trials can be captured in the spreadsheet. If there are multiple
registration numbers, please quote the ClinicalTrials.gov registration number.
Please upload the completed Excel spreadsheet to GEMS using the available upload function.
13 Due to the later submission date of January 2021 for this call, we are asking for registered clinical trial data up to 31 December 2020 to give a better picture of recent activity. We recognise that the data for this year may appear as an outlier due to the impact of Covid-19, however the HRB and the Panel will recognise this
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4.2 Cancer Clinical trials: graphical analysis
As an overview of the Clusters clinical trials portfolio please upload a single two-page document
comprising 4 graphs of trial data from 1 Jan 2017 to 31 Dec 2020 from the spreadsheet, displaying:
a. All registered trials during period broken down by phase “Column H”
b. All registered trials during period broken down by disease area “Column L”
c. All registered trials during period broken down by Sponsor i.e. Industry v Academic v Cancer
Trials Ireland sponsored (2017-2020)
d. # of registered trials commencing recruitment14 at each site within the Cluster each year during
period 2017-2020
See example available for download on GEMS for format of graph to be used, for ease of comparability
for the reviewers.
Please upload the graphs in word document/PDF format to GEMS using the available upload function.
4.3 Trial portfolio performance
Please detail the approach of the Cluster to the measurement of performance of individual trials and of
the portfolio overall. Give details of those performance metrics in the period 1 Jan 2017 – 31 Dec 2020,
such as but not limited to start up speed15 and recruitment reliability16, and note improvements in same
over time.
In addition, please provide the following detail:
- The tools and software packages used to aid performance monitoring
- the person(s) responsible for the collection and collation of such data
- changes in data collection process and procedures that the Cluster may use to improve the
collection and reporting of data
The word limit is 300 words.
4.3.1 Do you have a policy on the procedure and criteria for stopping trials?
If yes, please upload to GEMS using the available upload button.
4.4 Summary of recent achievements
14 The period after all approvals have been obtained and site green light has been issued 15 Start up speed- median number of days from receipt of protocol to regulatory approval or ethical approval 16 Recruitment reliability – number of actual participants randomised as % of number planned per study
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Please give brief details (bullet points preferred) to give an idea of recent achievements in the Cluster
and key areas of cancer clinical trial activity with a brief description of the role of Cluster staff in each
case. Areas to cover may include: key cancer clinical trials attracted to Ireland, healthcare innovations
tested, clinical guidelines, policy and practice influences, education/capacity building, IP and commercial
developments.
The word limit is 400 words.
5 Cluster Business Plan 2022-2026
5.1 Proposed Business Plan
Summarise the overall business plan that will achieve the strategic objectives of the Cluster highlighting
how current studies will be managed and completed and how future studies will be designed,
developed, selected and supported throughout their lifetime.
The word limit is 300 words.
5.1.1 Work package details
Please add a number of work packages which map to the relevant strategic objectives and detail how
they will integrate to deliver a coherent portfolio of high-quality cancer clinical trials including plans to
train, educate and support all personnel.
Each work package should include objectives, deliverables and milestones which will be finalised during
contract negotiations, as informed by the international review panel. Final deliverables will form part of
the contract should you be successful and will be used by the HRB for monitoring of the progress of the
award, in addition to agreed performance metrics
Work Packages should be mapped against estimated completion timelines in a Gantt chart, and any
milestones highlighted. In addition, please detail the resources and staff required for each work package
within the description of the work package All staff included in the application budget must be
associated with a work package in this section.
The Clusters are expected to integrate with other clinical trial infrastructures nationally to collectively
improve patient access to clinical trials, integrate relevant best practices where necessary to support
national performance for the benefit of the Irish clinical trials system. These include a National Cancer
Clinical Trial Network, National Clinical Trials Coordination Programme and HRB Trials Methodology
Research Network. Activity and resources should be assigned for that purpose. Ideally this should be a
distinct work package pertaining to coordination.
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The word limit is 150 words for each Work Package description, 200 words for the tasks and
deliverables and a further 200 for resources and staffing.
5.1.2 Gantt Chart (mandatory upload)
You must upload a Gantt chart that lists the above Work Packages, tasks and deliverables against the
estimated timelines for completion, together with any additional milestones/key dates (example in
Figure 1).
Figure 1: Example of Gantt chart template available from the HRB.
Please upload using the available upload option.
5.1.3 Staff resources Briefly summarise the staffing resources (to be funded by HRB and other sources) required to deliver the Work packages above (aligned to the table of staff as requested in section 7.5). Please note the Work package lead in each case. The word limit is 400 words.
5.2 Other Collaborations and Partnerships
Please provide a brief summary of plans for the development of collaborations and partnerships. Outline
any existing or planned collaboration, stating clearly if it as a local, regional, national or international
activity. The word limit is 1000 words.
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5.3 Patient and Public Involvement
PPI should play a critical role in clinical trials. Applicants are asked to describe how the Cluster will work
with a national Cancer Clinical Trial Network to develop an approach to embed PPI with cancer clinical
trials The word limit is 200 words.
5.4 Equality, diversity and inclusion
Equality, Diversity and Inclusion should be considered throughout your Cluster proposal. Please identify
and explain how you address Equality, Diversity and/or Inclusion in the Cluster.
The word limit is 300 words.
5.5 Potential Risks and Ethical Concerns
Please address any potential risk and/or harm to the safety of the patients or human
subjects/participants in the network, if relevant; and highlight any potential ethical concerns, even if not
part of this application, and how you propose to deal with them. The word limit is 300 words.
5.6 Dissemination and Knowledge Exchange Plan
Include a clear dissemination and knowledge exchange plan to indicate how the outputs you anticipate
producing during the current investment will be disseminated, shared and made openly accessible, in
line with HRB Open Access Policy17. Outputs include peer-reviewed publications, non-peer reviewed
publications and conference proceedings, reports, policy briefings, guidelines, training materials and so
on. Protection of Intellectual Property should be considered before data are disseminated18.
1. The HRB has a mandatory Open Access publication policy; demonstrate how you plan to make
all publications open access.
2. Who are the various audiences and communities that need to be targeted if these results are to
have any impact? What is your dissemination plan to address this, how will these audiences be
reached?
17 http://www.hrb.ie/research-strategy-funding/policies-and-guidelines/policies/open-access/ 18 All HRB Host Institutions must subscribe to the National Intellectual Property Protocol, ‘Inspiring Partnership- the national IP Protocol 2016: Policies and resources to help industry make good use of public research in Ireland’, prepared by Government/Knowledge Transfer Ireland to ensure transparent and consistent procedures for managing Intellectual Property from publicly funded research.
3. Describe how the findings of this research are to be publicised to the HSE, government
departments or international health community/organisations in a manner that will optimise
impact on health policy and/or practice.
4. Please reference aspects of the project/study undertaken to maximise chances of adoption
beyond the term of the award.
Types of publication routes19:
• Green Route: publishing in a traditional subscription journal. Articles are ‘self-archived’ (added)
to a repository (institutional or external subject-based) and usually made available after an
embargo period, which is set by the publisher.
• Gold Route: publishing in an open access or hybrid journal. Articles processing charges (APCs)
are paid so that the article is openly available immediately on publication and can be added to a
repository (institutional or external subject-based).
• HRB Open Research: rapid open-peer reviewed and open access platform for all research
outputs, with all publication charges covered centrally by the HRB at no expense to the grantee.
(www.hrbopenresearch.org).
The word limit is 500 words.
5.7 FAIR Data Management
Describe the approach to data management that will be taken during and after the project, including
who will be responsible for data management and data stewardship. Please consider the FAIR Guiding
Principles for scientific data management and stewardship: Findability, Accessibility, Interoperability,
and Reusability20. Please consider issues such as the types, volume and format of data, and what data
will be collected, processed or generated. Consider what metadata and documentation will accompany
the data. Will there be a globally resolvable, unique, persistent identifier (such as DOI)? What data
quality control measures will be used? Please consider how data will be stored and backed up. How will
data security be addressed? How and when will you share the data? How will you select data for
preservation and where data will be preserved long term (e.g. data repository, archive). What methods
or software tools will be required to access data? Who will be responsible for data management (e.g.
data steward) and the time needed for data management and for making data FAIR (costs may be added
under the budget section). Where it is envisaged that a Data Management Plan (DMP) will be created
during the project please indicate this and include delivery of the DMP and any planned revisions within
the project deliverables. The word limit is 500 words
5.8 Compliance with GDPR
19 Source: https://www.jisc.ac.uk/guides/an-introduction-to-open-access 20 Wilkinson, M. D. et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci. Data 2016 3:160018 doi: 10.1038/sdata.2016.18
Details are requested about the Network (Clinical Lead) Lead Applicant including their position and
status (contract or permanent), and their experience.
For Lead Applicants holding contract positions, a Letter of Support from the Head of School/Research
Centre must also be included.
The Lead Applicant’s contact and CV details (Name, contact information, institution, present position,
employment history, profession and membership of professional bodies) are managed in ‘manage my
details’ section of GEMS and are automatically included in any application created involving that
individual.
3.1.1 Publications and Funding Record
You are asked to include your 5 most relevant publications to this application on which you have acted
as senior author.
Publications are automatically included in any application created involving the Lead Applicant
Researcher. To update this information, edit the 'Update CV' section of 'Manage my Details' on GEMS.
You can then use the Publication selection tool in the relevant section of the application form to select
your 5 most relevant publications for this application.
You should also include your 5 most relevant funding awards as Principal Investigator or Co-Applicant.
For the purpose of this application form Funding Record details should be added directly on to the
application form and will not be pulled through from the ‘manage my details’ section of GEMS.
3.1.2 Evidence of Relevant Leadership Experience
The Network Lead Applicant is asked to describe any evidence of expertise or experience that they have
in leading consortia of different stakeholders and perspectives, particularly research consortia. The word
limit for this is 300 words.
3.1.3 Previous Experience in delivery of cancer clinical trials
The Network Lead Applicant is asked to provide any evidence or expertise they may have in previous or
current roles in the area of cancer clinical trials and to explain why this makes them a strong candidate
for the Network Lead Applicant role. This could include previous experience of working in collaboration
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to design and deliver cancer clinical trials, to improve the quality of cancer clinical trials or to promote
the conduct of cancer clinical trials at a local and national level. The word limit for this is 500 words.
3.1.4 Letters of Support for Lead Applications seeking contributions to salary
For Network Lead applicants who are seeking a contribution to their own salary (buy out time to enable
time to Lead the Network); a Letter of Support from the Host Institution (and their HI if different from
the award HI) and hospital where they hold their clinical position must also be included.
The formal letter on headed notepaper, dated and signed by the Head of School/Research Centre and
the appropriate signatory within their hospital, must include the following information; [Host Institution
– Hospital name] which is the host institution/hospital employer of [applicant - insert name] confirms
that [applicant - insert name]: holds an employment contract which extends until [insert date] or will be
recognized by the host institution upon receipt of the Cancer trials in Ireland award as a contract
researcher; Electronic signatures are preferable however or typed signatures are acceptable for letters
that are uploaded on the HRB GEMS system at this time.
3.2 Co-Applicants Details
A maximum of 10 Co-Applicants can be added.
The Co-Applicants can manage their contact and CV details (Name, contact information, institution,
present position, employment history, profession and membership details of professional bodies) under
‘Manage my Details’ section of GEMS and this information will be automatically included in any
application that involves this individual.
The Co-Applicants will be asked to provide additional information including their 5 most relevant
publications and their relevant funding record and their current position and status (contract or
permanent) will be requested in the application form.
3.2.1 Publications and Funding Record
You are asked to include your 5 most relevant publications to this application on which you have acted
as senior author.
Publications are automatically included in any application created involving the Lead Applicant
Researcher. To update this information, edit the 'Update CV' section of 'Manage my Details' on GEMS.
3.2.2 Previous Experience in delivery of cancer clinical trials
The Co-Applicant is asked to provide any evidence or expertise they may have in previous or current
roles in the area of cancer clinical trials relating to supporting collaborative clinical trials, network
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membership, commercialisation, and effect on healthcare practise and/or policy. The word limit for this
is 500 words.
3.2.3 Co- Applicant Role
Outline the role of the Co- Applicants in the Network on a day-to-day basis, including the amount of
time to be dedicated to working on this grant, either as a percentage or a proportion of a full time
equivalent (FTE). The word limit is 250 words.
3.3 Collaborator Details
A maximum of 10 collaborators can be added.
The information for Collaborators is not automatically drawn from the ‘Manage my Details’ section of
GEMS but must be entered by the Network Lead Applicant. Details for all Collaborators should be
provided including name, contact information, institution or organisation, present position or type of
organisation. If relevant and applicable they may also include employment history, profession and
membership details of professional bodies, Publications (maximum 5) and Funding Record and details of
any past or current grants held (including HRB grants) relevant to this application where the partner has
acted as Principal Investigator or Co-Applicant.
In addition, for each Collaborator a signed Collaborator Agreement Form must be provided. A template
Collaborator Agreement Form is available for downloaded from GEMS. Forms must be completed,
signed, dated and uploaded where indicated on HRB GEMS. Please label each form with the name of the
relevant Collaborator. Electronic or typed signatures are acceptable on letters/forms that are uploaded
on GEMS in this instance.
Collaborator Agreement form (mandatory upload)
Please upload a signed Collaborator Agreement Form for all named Collaborators in this section.
Collaborator Role
Outline the role of the Collaborators role in the Network on a day-to-day basis, including the amount of
time to be dedicated to working on this grant, either as a percentage or a proportion of a full time
equivalent (FTE). The word limit is 250 words.
3.4 Network Lead Applicant Role
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Please indicate the current commitment to research/clinical/teaching/other, either as a percentage or a
proportion of a full time equivalent (FTE). Outline the role of the Clinical Lead Applicant in the Network
on a day-to-day basis including amount of time to be spent working on the network either as a
percentage or proportion of a full time equivalent (FTE).
The word limit is 250 words.
3.5 Network Clinical Lead Profession and Occupational Speciality Environment
Please state the Clinical Leads’ profession and occupational speciality, the approximate number of
individuals trained in this speciality in Ireland and approximately how many of these are engaged in
research and where are the main centres/sites that this research is currently being undertaken? The word
limit is 200 words.
3.6 Staff
Please upload a word document containing a table with details of staff (both current and future) required
for delivery of the business plan. Specify the staff type, state the time each person will spend on the
grant, either as a percentage or proportion of a full time equivalent (FTE), indicate which work packages(s)
they will be involved in, describe their role in the proposed National Cancer Clinical Trial Network over
the lifetime of the award. If known you are asked to provide their name. Note - At least 0.5 FTE Programme
Manager must be provided for the duration of the award (funded by HRB or in-kind).
A template word document can be downloaded here.
The table will provide an overview to the review panel of the Network applicant team members and
their contribution to the national network.
Staff Type Name Work package (deliverable)
FTE Institution (affiliation- HSE or HI)
Funding sources
Employment Type Perm/ Contract/Temp
Director Jane Smith 1.3 1.0 UCD/HSE HRB/HI Perm
Associate director
John Brown 2.4 0.5 TCD HI Perm
Director of Nursing
Jane Smith 3.2 1.0 HSE HRB Perm
Senior Research nurse
John Brown
1.2
0.5
RSCI/HSE
HSE
Contract
Research nurse
Jane Smith
5.2 1.0 UL/HSE HI Perm
Programme Manager
John Brown
1.4
1.0
HI
Perm
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Research manager
Jane Smith
2.2
1.0
EU
Temp
Research assistant
John Brown 3.1 1.0 HRB/HSE Perm
Etc.
3.6.1 Justification for Staff
Please give details of all staff to be funded in the Network. Note that you must justify the nature of all
staff relative to the activity of the Network. If funding is requested for known staff, please include the
following details: Name, address, present position, academic qualifications and professional
qualifications. It is expected that the award will predominantly offer salary support for core staff
members within the Network including, but not limited to clinical research nurses and data managers.
The word limit is 400 words.
3.7 Strength and Complementarity of the Network Applicant Group
Please describe how the formation of this network applicant group strengthens this proposal in terms of
complementarity of scientific expertise, synergistic potential and the added value of the collaboration.
Show how the team has the collective expertise, competencies and experience to successfully deliver
this network, under the leadership of the Network Lead Applicant(s). Does the applicant group have
appropriate statistical, methodological and data management expertise to enable them to develop a
portfolio of suitably designed studies (if not then describe how this will be accessed in the next section
“infrastructure and support”). The word limit is 800 words.
4. Network Overview
4.1 Entity/Network name Please name your entity or network in the space provided.
4.2 Network Duration and Start date
Please indicate the expected start date. Please note that awards are 60 months in duration and all awards are expected to commence during January 2022. Please note that the earliest start date will be 01 January 2022.
4.3 Network Summary
Please provide a summary of the proposed activities of the Network and how they might contribute to
the provision of equitable access for all cancer patients to high quality cancer clinical trials across the
island of Ireland. Please also describe how this Network sits within the national context. The word limit
is 500 words.
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4.4 Lay Summary
Please provide a lay summary of the Network and its proposed activities. The lay summary needs to be
written as a plain English summary, such that it is a stand-alone document that is clear, easy to
understand, and is easily accessible to a broad lay audience. Avoid the use of highly technical terms. This
summary may be used when providing information to the public concerning the variety of research
funded by the HRB. The word limit is 300 words.
5. Network Description
Please ensure that your application is focused, and that sufficient evidence is provided to enable the
international selection panel to reach a considered judgement as to how the proposed Network meets
each of the assessment criteria.
In addition to this there are a number of expectations set out in the guidance notes for the Network.
Please ensure that you describe how this application will be used to meet the expectations of a national
network under the call for cancer trials in Ireland.
A National Cancer Clinical Trials Network will be expected to:
• Partner with an academic host institution
• Provide Governance support as Sponsor for the conduct of multicentre regulated cancer clinical
trials
• Provide Support services for studies including project management, database design and build,
clinical trial data management, data analysis, statistical analysis plans and reports, monitoring,
reporting and administration of trial activity at each approved cluster where required. They will
also be mandated to report on trial delivery and performance.
• Provide Networking support for Clusters to;
o Network and integrate at a national level the critical mass of expertise and resources
needed to provide Irish leadership in Investigator-led and commercial cancer clinical
trials
o Pro-actively establish and grow partnerships with Collaborative groups, Charities and
Industry, as appropriate to the portfolio of cancer trials
o Design and develop a portfolio of high-quality cancer clinical trials
o Ensure policies on the:
▪ study selection and prioritisation for the network as a whole
▪ peer review of clinical trials which do not come with external competitive
funding e.g. commercial trials
▪ procedure and criteria for stopping trials within the cancer portfolio that is
maintained and implemented
▪ management of contributions from industry collaborators including a charging
model/list of fees for commercial studies
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o Embed public and patient involvement in all cancer clinical trials
o Provide network support to all trial delivery teams at sites by providing a
communication platform for all members e.g. development of a community of practice.
5.1 Background to Network
This scheme will provide support for established entities with a previous track record of providing
services and supports for the conduct and delivery of high quality, safe and compliant cancer clinical
trials.
Describe the background to the cancer clinical trial network including what is already in place, setting this
clearly within a national context. Explain the rationale behind the establishment of a national cancer
clinical trials network and what it has achieved to date. Articulate the added value from this network and
what would this HRB award enable that would not happen otherwise?
The word limit is 1000 words.
A file upload option is available to include an attachment to support the background to network
provided. A maximum of 8 figures, which can be a combination of images, graphs, tables, scales,
instruments or surveys, may be uploaded as a single document on HRB GEMS. They must not be
embedded within the text of the background to network. The maximum size is 2MB.
5.2 Vision and Mission
Please state the vision and mission of the Network, that includes the period 2022 - 2026. The word limit
is 50 words
5.3 Strategic Direction
Briefly describe the strategic position of the Network. Detail key opportunities and strategic challenges
for the Network. Please describe the strategic objectives aligned with the vision and mission including
details of planned strategic alignment with the following:
- National Cancer Strategy 2017-202622,
- The proposed Cancer Clinical Trial Clusters
- CRF/Cs
- National clinical trials coordination programme
- regional integrated care organisations
- other collaborative groups, charities and industry as appropriate to the portfolio.
Describe the overarching research strategy of the national cancer clinical trial network; if not currently in
Give a high-level description of the cancer clinical trials portfolio (on-going and recently completed
studies (2017/18/19/20)23, demonstrating that the Network applicant team members have worked
together on cancer clinical trials.
Please outline planned studies for the term of the award (with proposed team members), which
demonstrates the scientific breadth and depth of the network.
For each proposed study, please indicate where funding has already been secured for planned studies, or
if it is intended to bid for competitive funding (stating the potential funding source including supports
claimed under Cluster applications). The word limit is 2000 words.
5.4 Network Infrastructure
Please describe the current levels of infrastructure present in the Network or the proposed level of
infrastructure, utilised to support cancer clinical trials. Include reference to specific personnel and their
roles and responsibilities.
If successful in this award what levels of infrastructure will be required for the successful delivery of the
proposed business plan? What reorganisation (if any) will be required to fulfil these requirements?
The word limit is 500 words.
5.5 Management, Governance and Strategic Oversight
Provide a high-level description of the oversight, advisory or governance structures that are currently in
place or will be put in place for the Network. Please provide details about any reporting relationships
with the HI, Clusters, and external governing bodies as appropriate. Include details of Governance
Board, Scientific Advisory Boards and any other committees as applicable, including the scientific
advisory groups of the national cancer clinical trial network (please detail role/membership/frequency
of meetings). The word limit is 500 words.
The National Cancer Clinical Trials Network and Clusters are also expected to cooperate fully with any
HRB Clinical Trials Infrastructure Expert Advisory Group. This Expert Advisory Group is anticipated to
assist the HRB in the strategic oversight and performance monitoring of the Infrastructures, networks
and Interventions portfolio.
5.5.1 Organogram (mandatory upload) Please include an organisational chart/organogram to illustrate the Cluster structure, management and
governance using the file upload option on GEMS.
23 Details of individual studies performance in the specified four year period will be entered in a separate section numbered 5 below.
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5.6 Operational model
Describe the current or proposed operational model within the Network which supports a national
cancer clinical trial portfolio. Please describe how this operational model is appropriate to the stage and
scale of the Network’s activities.
With reference to the expectations of a Network detailed in the guidance document please outline in
detail how the operational model does/will fulfil expectations including:
• Provision of governance support for studies
• Provision of support services for studies
• Provision of networking support for clusters
Please describe under each of the above bullet points, the scope of supports that will be provided and
the exact process for access and provision of same.
Explain how the network currently scales resources according to demand for support. Describe
processes for making decisions on scientific direction and allocation of resources (e.g. selection of
studies).
Briefly describe key policies and processes. This should include but is not limited to study selection and
prioritisation, peer review of cancer clinical trials, procedures for stopping trials, study costing, resource
allocation and management of contributions from industry collaborators. You may embed links to key
SOPs/policies.
Please note the results of recent audit reports, if available.
The word limit is 1500 words.
A file upload option is available to include an attachment to support your operational model description.
A maximum of 8 figures, which can be a combination of images, graphs, tables, scales, instruments or
surveys, may be uploaded as a single document on HRB GEMS. They must not be embedded within the
text of the operational model description. The maximum size is 2MB.
5.7 Do you have a policy on the procedure and criteria for stopping trials?
If yes, please upload to GEMS using the available upload button.
5.8 Network integration with the Clusters
Summarise the planned network integration and activities with the Clusters. Explain how the network
leadership will manage growth and expansion of the network to engage a broader community of
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researchers/clinicians. Specifically explain how new members will be incorporated during the lifetime of
the award and at what point will this happen.
The word limit is 1200 words.
5.8.1 Clinical Research Infrastructure Agreement Form (mandatory upload)
A Clinical Research Infrastructure Agreement Form must be completed for each Cluster and can be
downloaded from GEMS. The Form must be completed, signed, dated and uploaded on GEMS.
Electronic signatures are acceptable for letters/forms that are uploaded on GEMS.
5.9 Host Institution Support
Describe the infrastructure, facilities, specialist expertise and other support available at the Host
Institution for the Network. Summarise if any additional support or commitment is proposed by the
Host Institution or participating/collaborating institutions e.g. financial and/or other support. Please
include details of additional institutional supports in areas such as business development, legal,
marketing expertise where this is being provided above and beyond the activities/expertise of members
of the Network team.
The word limit is 300 words.
5.10 Financial Management support for Network
Please provide details about the current financial management processes to manage Network income
and expenditure. Please include information on accounts to be used, processes such as invoicing, and
processes to enable income and expenditure to be reported on an annual basis. Please comment on the
appropriateness of the system and any planned changes.
The word limit is 200 words.
5.11 Letters of Support (mandatory upload)
Applications will need to be coordinated at a national level. This may take the form of letters of support
from host institutions, hospital groups, CRF/Cs, Chairs of the Cancer Disease Specific Sub-Groups and
other relevant stakeholders.
6. Clinical Trial Performance to date
6.1 Registered clinical trials activity
Please list all registered cancer clinical trial activity at Cancer Trials Ireland from 1 Jan 2017 to 31 Dec 2020
from earliest to most recent, in the accompanying Metrics Excel spreadsheet template. A full explanation
of terms is given in the “Clinical Trial Data Definitions” document.
Please note that only registered trials can be captured in the spreadsheet. If there are multiple
registration numbers, please quote the ClinicalTrials.gov registration number.
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Please upload the completed Excel spreadsheet to GEMS using the available upload function.
6.2 Cancer Clinical Trials: graphical analysis
As an overview of the current Network/organisation clinical trials portfolio please upload a single two-
page document comprising 4 graphs of trial data from 1 Jan 2017 to 31 Dec 2020 from the spreadsheet,
displaying:
e. All registered trials during period broken down by phase “Column H”
f. All registered trials during period broken down by disease area “Column L”
g. All registered trials during period broken down by Sponsor i.e. Industry v Academic v Cancer Trials Ireland sponsored (2017-2020)
h. # of trials opening at each site per year (2017-2020)
See attached example for format of graph to be used, for ease of comparability for the reviewers.
Please upload the graphs in word document/PDF format to GEMS using the available upload function.
6.3 Trial portfolio performance
Please detail the approach of the Network to the measurement of performance of individual trials and of
the portfolio overall.
Give details of those performance metrics in the period 1 Jan 2017 – 31 Dec 2020, such as but not limited
to start up speed24 and recruitment reliability25, and note improvements in same over time.
In addition, please provide the following details:
- Was planned recruitment achieved: globally?
- Was planned recruitment achieved: at the sites in Ireland?
- The tools and software packages used to aid performance monitoring
- the person(s) responsible for the collection and collation of such data
- changes in data collection process and procedures that the Network may use to improve the
collection and reporting of data
The word limit is 300 words.
6.4 Other clinical research activity
Please describe the breadth of research in the Network and give an indication of the current level of
activity in cancer clinical trials, compared with other cancer clinical research studies.
The word limit is 200 words.
24 Start up speed- median number of days from receipt of protocol to regulatory approval or ethical approval 25 Recruitment reliability – number of actual participants randomised as % of number planned per study
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6.5 Summary of recent achievements
Please give brief details (bullet points preferred) to give an idea of recent achievements in the network
and key areas of activity with a brief description of the role of Network staff in each case. Areas to cover
may include: key cancer clinical trials attracted to Ireland, healthcare innovations developed/tested,
clinical guidelines, policy and practice influences, education/capacity building, IP and commercial
developments. The word limit is 400 words.
7. Network Business Plan (2022-2026)
7.1 Proposed Business Plan
Summarise the overall business plan that will achieve the strategic objectives of the Network
highlighting how current studies will be managed and completed and how future studies will be
designed, developed, selected and supported throughout their lifetime. The word limit is 300 words.
7.1.1 Proposed Business Plan
Please add a number of work packages which map to the relevant strategic objectives and detail how
they will integrate to deliver a coherent portfolio of high quality cancer clinical trials and network the
cancer clinical trial community.
Each work package should include objectives, deliverables and milestones which will be finalised during
contract negotiations, as informed by the international review panel. Final deliverables will form part of
the contract should you be successful and will be used by the HRB for monitoring of the progress of the
award, in addition to agreed performance metrics.
The Network is expected to integrate with other HRB-funded clinical trial infrastructures nationally to
collectively improve patient access to clinical trials, integrate relevant best practices where necessary to
support national performance for the benefit of the Irish clinical trials system. These include the Cancer
Clinical Trial Clusters, Clinical Research Facility/Centres, National Clinical Trials Coordination Programme
and HRB Trials Methodology Research Network. Activity and resources should be assigned for that
purpose. Ideally this should be a distinct work package pertaining to coordination.
PPI should play a critical role in clinical trials. It is the role of the Network under this call to promote and
support the embedding of PPI into cancer clinical trials in Ireland. The promotion of high quality and
meaningful PPI in Network activities and cancer clinical trials in Ireland should be a distinct work
package for the Network. The work package should capture both the larger scale national promotion of
PPI and the day to day activities of providing support for researchers’ PPI activities both during the
development of an application and during the conduct of a trial.
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Work Packages should be mapped against estimated completion timelines in a Gantt chart, and any
milestones highlighted. In addition, please detail the resources and personnel required for each work
package within the description of the work package All personnel included in the application budget
must be associated with a work package both in this section and in this section 3.8.
The word limit is 2000 words.
7.1.2 Gantt chart (mandatory upload)
You must upload a Gantt chart that lists the above Work Packages, tasks and deliverables against the
estimated timelines for completion, together with any additional milestones/key dates (example in
Figure 1).
Figure 2: Example of Gantt chart template available from the HRB.
Please upload the completed Gantt Chart using the available upload function.
7.2 Other Collaborations and Partnerships
Please provide a brief summary of plans for the development of collaborations and partnerships. Outline
any existing or planned collaboration, stating clearly if it as a local, regional, national or international
activity. The word limit is 1000 words.
7.3 Trial Registration and Reporting
Please outline the procedure for ensuring the timely registration and reporting of all clinical trials
sponsored by the network. Outline how this information will be recorded and who will be responsible
for this information. The word limit is 200 words.
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7.4 Equality, diversity and inclusion
Equality, Diversity and Inclusion should be considered throughout your Network proposal. Please identify
and explain how you address Equality, Diversity and/or Inclusion in the Network.
The word limit is 300 words.
7.5 Potential Risks and Ethical Concerns
Please address any potential risk and/or harm to the safety of the patients or human
subjects/participants in the network, if relevant; and highlight any potential ethical concerns, even if not
part of this application, and how you propose to deal with them. The word limit is 300 words.
7.6 Communication Plans
Please provide a clear communications plan to indicate how you plan to identify and engage with your
stakeholders. Details may include for example:
• Stakeholder analysis
• Key communication messages
• Timing and mode of engagement
• Team member responsible for communications activities
Include a clear dissemination and knowledge exchange plan to indicate how the outputs you anticipate
producing during and after the National Cancer Clinical Trials Network will be disseminated, shared and
made openly accessible, in line with HRB Open Access Policy26. Outputs include peer-reviewed
publications, non-peer reviewed publications and conference proceedings, reports, policy briefings,
guidelines, training materials and so on. Protection of Intellectual Property should be considered before
data are disseminated27.
The word limit is 500 words.
7.7 FAIR Data Management
The HRB Policy on Research Data Management governs data gathered and generated in whole or in part
from HRB-funded research from 1st of January 2020. While Research Data Management Plans will have
to be developed on a study-by-study basis, Network Lead Applicants should consider how studies within
the portfolio can ensure they are in line with policy requirements (of HRB and other funders). Please
describe how you will work with support of data stewards (within the network) or other data-related
services support in the Host Institution (typically library and ICT and digital services, etc) on approaches
to data management and stewardship for the Network.. Please consider the FAIR Guiding Principles for
26 http://www.hrb.ie/research-strategy-funding/policies-and-guidelines/policies/open-access/ 27 All HRB Host Institutions must subscribe to the National Intellectual Property Protocol, ‘Inspiring Partnership- the national IP Protocol 2016: Policies and resources to help industry make good use of public research in Ireland’, prepared by Government/Knowledge Transfer Ireland to ensure transparent and consistent procedures for managing Intellectual Property from publicly funded research.
scientific data management and stewardship: Findability, Accessibility, Interoperability, and
Reusability28. Please consider issues such as the types, volume and format of data, and what data will be
collected, processed or generated. Consider what metadata and documentation will accompany the
data. Will there be a globally resolvable, unique, persistent identifier (such as DOI)? What data quality
control measures will be used? Please consider how data will be stored and backed up. How will data
security be addressed? How and when will you share the data? How will you select data for preservation
and where data will be preserved long term (e.g. data repository, archive). What methods or software
tools will be required to access data? Who will be responsible for data management (e.g. data steward)
and the time needed for data management and for making data FAIR (costs may be added under the
budget section). The word limit is 500 words
7.8 Compliance with GDPR
Please comment on how your proposed Network complies with The General Data Protection Regulation
(EU) 2016/679, if relevant, especially where execution of study activity involves the transfer of data
outside of the EU. The word limit is 200 words.
8. Project Budget
8.1 Project Budget
Please provide a summary and justification of the costs and duration associated with the award.
Total HRB funding for the National Cancer Clinical Trial Network will be up to a maximum of €1,461,250
per annum over five years (inclusive of 25% overheads).
The award will predominantly offer support for operational costs such as, but not limited to salary for
• core staff in database design and build, clinical trial data management, data analysis, statistical
analysis, monitoring etc.
• administration support and project management support for the central function, and / or
• clinical lead buy-out time to strategically lead the Network (maximum salary contribution of
€100K per annum).
HRBs investment through this specific instrument will not support;
• funding for individual cancer clinical trials as it is expected that trials should come with
competitive funding from sources with effective independent international peer review, such as
the HRB Definitive Interventions and Feasibility Awards, other national/international funding
sources, international collaborative groups and / or industry-funded studies
28 Wilkinson, M. D. et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci. Data 2016 3:160018 doi: 10.1038/sdata.2016.18
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• costs associated with routine patient care or translational studies, biobanks, patient registries
and questionnaires
• establishing new premises, including building work, or fit-out of buildings.
You are required to provide individual work package budgets and one overall budget summary.
Budgets will be set out in a modular fashion, and it is possible that the International Expert Panel will
recommend funding for some modules but not others.
A full detailed breakdown of costings and justification for all funding is required for items listed under
each subheading within GEMS.
Please
In line with the allowable costs described in the guidance notes funding should be requested under the
following budget headings: Personnel costs, Running costs, FAIR Data management costs, Equipment
costs, Dissemination costs and Overhead costs.
Note: You are strongly advised to seek guidance from the research office/finance office in the host
institution before completing this section of the form. The HRB will not provide additional funding in the
case of either under-estimates or over expenditure.
Funds will be provided for the following:
1. Personnel costs Must be listed for all salaried personnel under each of the following
subheadings (a-c):
Contributions to Personnel costs: as appropriate and justified given
the scale and scope of Network activities (e.g. Trial design expertise,
Data Analysis, Statistical Analysis, clinical trial monitoring).
a) Salary Gross Annual Salary (including 5% employee pension contribution)
negotiated and agreed with host institution. Applicants should use the
IUA website scales for the most up-to-date recommended salary scales
for academic researchers http://www.iua.ie/research-
innovation/researcher-salary-scales/
Please note employee pension contribution of 5% has already been
incorporated into the IUA gross salary figure.
Applicants are advised that public sector pay increases for the period
until end of 2020 have been agreed. Please find new pay scales at
https://www.iua.ie/research-innovation/researcher-salary-scales/ If
your application stretches beyond 2020; please apply a salary
contingency of 2.5% p.a.
Applicants should include annual pay increments for staff and related
costs (pension contribution, employer’s PRSI contribution, and
overhead contribution) in the budget.
b) Employer’s PRSI Employer’s PRSI contribution is calculated at 11.05% of gross salary.
c) Employer Pension
Contribution
Pension provision up to a maximum of 20% of gross salary will be paid
to the host institution to enable compliance with the Employment
Control Framework (an additional 5% employee contribution is part of
the salary). The level of employer contribution should be in
accordance with the model adopted by the host institution.
If applicable, state the amount of employer contribution based on the
pro rata salary and note the % of pro rata salary used to calculate this
for reference.
Circular Letter 6/2007 states that the pensions contribution of all
Public Health Service employees who, on or after 1 June 2007, are
granted secondments or periods of special leave with pay to enable
them take up appointments with other organisations, including other
Public Health Sector organisations, will be increased to 25% of gross
pensionable pay. The rate of 25% of gross pensionable pay referred to
in this context is the pension contributions to be paid by the body to
which the employee is seconded – it does not include any pension
contributions which employees make themselves. Where no such
arrangements are in place, the HRB will not be liable for costs. If
requesting pension costs linked to Circular 6/2007, please provide
details as justification for the request.
2. Running Costs Eligible running costs include but are not limited to a communication platform for all members, travel, meeting costs and networking events. All costs must be fully justified. Costs associated with involving members of the public or patients in in
PPI activities e.g. consultation workshops, costs of participation in
advisory groups, travel expenses, honoraria, etc. should be charged to
running costs.
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The following costs are ineligible and will not be funded: inflationary increases, cost of electronic journals. Note: Please see a list of costs that fall within the overhead
contribution below and which should not be listed under running
costs.
4. FAIR data management
costs
Costs related to planning in relation to data management,
FAIRification, storage and archiving of research data in line with best
practice of data management and stewardship and the FAIR principles
as applicable to the portfolio of studies. Cost of data management
support calculated by hourly rates should also be included here. Data
Steward consultancy to support Network activities may be included.
Please consult Appendix III of the Guidance Notes for examples of
eligible costs.
5. Equipment Funding for small items of suitably justified equipment can be included
in this section. Personal/Stand-alone computers will not be funded as
these are considered a standard piece of office equipment, i.e.
overhead. All costs must be inclusive of VAT, where applicable.
We do not expect costs in excess of €20,000 for this call.
6. Dissemination Costs Costs associated with publication of results, seminar/conference
attendance (provide details of name and location, where possible) and
any other means of communicating/reporting research outcomes as
detailed under knowledge dissemination and exchange activities in the
dissemination and knowledge translation plan as well as costs related
to data sharing. Please refer to the HRB policy on Open Access to
Published Research29. Please list dissemination costs under the
following categories: publications, conferences, other activities
30 Please note that not all FAIR data are necessarily open. Where data raises data protection or security concerns, controls and limits on data access will be required. In some cases, it will be appropriate for researchers to delay or limit access to data in order to secure intellectual property protection. Any such restrictions on access should be justified, made explicit via machine-actionable licensing and built-in accessibility protocols mechanisms. 31 https://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-policy-on-management-and-sharing-of-research-data/