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2002Dublin Molecular Medicine Centre (DMMC) established by TCD and UCD

2005RCSI joinsDMMC

2005Irish Clinical Research Infrastructure Network (ICRIN) formed by DMMC partners, NUI Galway & UCC

2006European Clinical Research Infrastructure Network (ECRIN) membership awarded

2008Molecular Medicine Ireland (MMI) established by NUI Galway, RCSI, TCD, UCC and UCD

2008Clinician Scientist Fellowship Programme launched

2008Dublin Centre for Clinical Research established

2011Clinical & Translational Research Scholars Programme launched

2013Irish Programme for Stratified Prostate Cancer Therapy (iPROSPECT) funding awarded

2 October 2017 marked the rebrand of Molecular Medicine Ireland as Clinical Research Development Ireland (CRDI). CRDI is a not-for-profit research partnership established by NUI Galway, Royal College of Surgeons in Ireland, Trinity College Dublin, University College Cork and University College Dublin, their medical schools, associated academic hospitals and clinical research facilities, with the objective of accelerating the translation of biomedical research into improved diagnostics, therapies and devices for patients.

CRDI builds on the achievements of Molecular Medicine Ireland which was incorporated in 2008 by the five aforementioned universities, together with its predecessor the Dublin Molecular Medicine Centre (DMMC), a partnership initiated by UCD and Trinity College Dublin in 2002, with the inclusion of Royal College of Surgeons in Ireland in 2005.

Enabling Clinical and Translational Research

2011Clinical & Translational Research Scholars Programme launched

2013Irish Programme for Stratified Prostate Cancer Therapy (iPROSPECT) funding awarded

2017Clinical Research Development Ireland (CRDI) launched

2014Irish Prostate Cancer Outcomes Research (IPCOR) funding awarded

2015HRB Clinical Research Coordination Ireland established

2015Centre for Research in Medical Devices (CÚRAM) funding awarded

2016Irish Clinical Academic Training (ICAT) Programme funding awarded

CRDI is funded by the five universities along with programme funding from a number of sources including the Health Research Board, Enterprise Ireland, Wellcome Trust, Science Foundation Ireland, Irish Cancer Society, Movember Foundation and the Health Service Executive.

CONTENTS

Page 02 CRDI Timeline

Page 04 2017 in Numbers

Page 05 2017 Highlights

Page 06 Chairman’s Statement

Page 08 CEO’s Statement

Page 10 CRDI Structure & Governance

Page 11 CRDI Strategy

Page 12 CRDI Board

Page 14 CRDI Launch

Page 18 HRB CRCI

Page 28 International Clinical Trials Day 2017

0 Corporate Enabling of Clinical Research (CECR)

Page 32 Irish Prostate Cancer Outcomes Research (IPCOR)

Page 34 iPROSPECT

Page 36 Biobanking

Page 38 CRDI/CÚRAM Partnership

Page 40 Wellcome-HRB Irish Clinical Academic Training

(ICAT) Programme

Page 44 Wellcome - HRB ICAT Programme First

Annual Scientific Retreat

Page 46 Short Courses

Page 48 CRDI PhD Programmes Alumni

Page 50 Comms Update

Page 51 Financial Statement

Page 52 CRDI Team

Page 54 Abbreviations & Acronyms

Clinical Research Development Ireland4 CRDI Annual Report 2017

2017 IN NUMBERS

13k+WEBSITE VISITORS IN 2017

33.87% INCREASE ON 2016

246ADVANCED PROSTATE CANCER PATIENT SAMPLES IN iPROSPECT

BIOBANK

95ATTENDEES OF TECHNIQUES

& STRATEGIES COURSE

2 OctCRDI OFFICIALLY LAUNCHED

BY MINISTER FOR HEALTH IN FARMLEIGH

148FEASIBILITY

ASSESSMENTS PROCESSED

5CRF/CS MUTUAL

RECOGNITION SCHEME PEER REVIEW VISITS

COMPLETED

2,946MEN REGISTERED TO

IPCOR STUDY IN 2017

1stANNUAL ICTD

SEMINAR HELD

15CECR STAKEHOLDERS

€16mICAT PROGRAMME FUNDING IN TOTAL

13ICAT PROGRAMME

HEALTH AND ACADEMIC PARTNERS

18PARTICIPANTS IN CRDI/CÚRAM

MEDICAL DEVICE e-LEARNING MODULE

Pg 46

Pg 14

Pg 28

Pg 34

Pg 32

Pg 23

Pg 50

Pg 23Pg 40

Pg 40

Pg 38

Pg 30

5CRDI Annual Report 2017

2017 HIGHLIGHTS

WELLCOME-HRB ICAT PROGRAMME FIRST ANNUAL RETREATGrand Hotel Malahide,County Dublin

The Wellcome-HRB ICAT Pro-gramme hosted its first Annual Scientific Retreat in the coastal town of Malahide near Dublin in November 2017. The theme of the Retreat was ‘Careers in Academic Medicine’.

For more see page 44 »

09NOV

CLINICAL RESEARCH DEVELOPMENT IRELAND LAUNCHFarmleigh House,Dublin

On Monday 2 October 2017, Clinical Research Development Ireland (CRDI) was unveiled by Minister for Health, Simon Harris TD, as the new name for Molecular Medicine Ireland in the stately and historic surround-ings of Farmleigh House.


02OCT

INTERNATIONAL CLINICAL TRIALS DAY 2017, Round Room, Mansion House, Dublin

15MAY

HRB CRCI hosted a special seminar on “Improving Patient Health Through Clinical Re-search” on Monday, 15th May 2017 in the Round Room at the Mansion House, Dublin 2, to celebrate International Clinical Trials Day 2017.



On behalf of the Board of Directors, it gives me great pleasure to present the 2017 Clinical Research Development Ireland Annual Report.

2017 was a defining year for Clinical Research Development Ireland. Follow-ing the reaffirmation by the five institu-tional members of their commitment to the partnership for a further five years, the CRDI Board undertook to recruit a new Chief Executive. I extend a warm welcome on behalf of the Board to Dr Pat O’Mahony who assumed this posi-tion on 1 January 2017. An immediate task for the new Chief Executive was the development of a 5-year strategy for the organisation. A comprehensive consultation process was initiated early in the year, led by Dr O’Mahony, with Board members and their associates in the partner institutions, as well as with key external stakeholders from both the public and private sectors. I am pleased to report that this resulted in the delivery of the CRDI Strategic Plan 2017 – 2021 which the CRDI

Board duly approved at their meeting in June. This comprehensive document aims to advance patient care and health service delivery by supporting the de-velopment of clinical and translational research across our partner academic institutions, their medical schools and associated hospitals. A key highlight of the year was the rebrand of the organisation to Clinical Research Development Ireland. This was formally marked on 2 October with a special event in Farmleigh House in the presence of the Minister for Health, Mr Simon Harris TD, and founder and former Board Director, Professor Dermot Kelleher, along with leading experts in clinical and translational research from both Ireland and abroad. While respecting past achievements, this event signalled the start of a new chapter in the evolution of the partnership as it con-tinues to be an effective and innovative force for the development of clinical and translational research in Ireland.

CRDI welcomed Minister Harris’ expressed recognition of the value of public investment in science and research for health as an investment in a healthier society and a more productive economy, and we acknowledge the substantial funding awards made available through the Health Research Board and Science Foundation Ireland to further strengthen Ireland’s capacity to conduct clinical and translational research. We were also encouraged to learn that the HSE has appointed a research and development lead who will develop a R&D management plan in consultation with relevant stakeholders, to address the delivery of the key actions originally set out in the Action Plan for Health Research 2009-2013. CRDI is grateful for this renewed focus of activity and we look forward to assisting and supporting the HSE in the development and imple-mentation of this plan.

Chairman’s Statement

A key highlight of the year was the rebrand of the organisation to Clinical Research Development Ireland. This was formally marked in October with a special event in Farmleigh House in the presence of the Minister for Health, Mr Simon Harris TD


During 2017 an important strategic ini-tiative was reinvigorated under the aegis of CRDI. Entitled Corporate Enabling of Clinical Research, this initiative aims to identify and provide solutions to the difficulties faced by academic institutions in the sponsorship and management of clinical trials, particularly with regard to the areas of governance, contracts and insurance. I would like to commend the concerted efforts of Ms Nora Geary of UCC, Dr Paola Della Porta of RCSI and Dr O’Mahony for their leadership of this initiative which involves a wide network of specialists in areas ranging from legal, financial, quality and regulatory to risk management and clinical research. I would like to take this opportunity to thank the Board of CRDI for their on-going support and commitment to Clinical Research Development Ireland and to congratulate Dr O’Mahony for a very successful first year at the helm. I would like to acknowledge Paul Barry for stepping up to the role of Acting Chief Executive and also the staff for their un-

wavering dedication and contribution to the mission of CRDI during the recent period of economic uncertainty for the partnership. In 2018, we welcome the prospec-tive expansion of the CRDI partnership with the much anticipated accession of the University of Limerick, and we look forward to further collaborative successes in clinical and translational research and to strengthening our links with Queen’s University Belfast.

Thomas LynchChairman, Clinical Research Development Ireland


I am very pleased to have taken up the role of Chief Executive on 1 January 2017 and to now be able to present this Clinical Research Development Ireland Annual Report for 2017. When I joined, the organisation was known as Molecular Medicine Ireland (MMI), and formerly the Dublin Molecular Medicine Centre (DMMC). In its 15 years of operation, it had achieved much through the collaboration of our partner academic institutions with a wide range of other stakeholders. We value all the achieve-ments under both the MMI and DMMC brands and thank sincerely all those who contributed in any way over that period. The Board agreed in early 2017 that a new strategy was required and this included the re-branding to CRDI. The launch of the new five-year strategy and the rebrand was formally announced by Simon Harris TD, Minister for Health, at a function on 2 October at Farmleigh House. Further details of the launch appear on Page 14 in this report. The CRDI Strategic Plan 2017 – 2021 sets out 6 high level Strategic Goals as follows:

• Advance the development of asophisticated, coordinatedclinical and translational researchpartnership

• Develop and support clinical andtranslational researchinfrastructure and delivery

• Develop and support clinical trialsdelivery

• Develop and support education andtraining

• Develop capability across networkpartners and CRDI

• Advocate for adequate funding forthe development of clinical andtranslational research.

Each of the 6 Goals has a number of associated objectives and these form the basis for all our activities. On reading the Strategic Plan you will see the emphasis placed on partner-ships. As an entity, we are of and for our partner institutions, and success in any of our endeavours and work streams can only be achieved by working in partner-ship together and with stakeholders. We are stronger for this partnership model

and it brings a real and tangible credibili-ty and critical mass to our work. I would like to record my thanks to all our partner institutions, their representatives on the Board, and our independent Board members and Chair Tom Lynch for all their help and support throughout 2017. Their commitment is much appreciated and I recognise that they all have very busy work lives and heavy workloads in their respective roles. Core CRDI staffing comprises a small team of dedicated colleagues who are featured on Page 52. I thank each in turn for their commitment across a broad array of programmes and initiatives. All this effort adds up to delivering on our strategic goals as set out in our Strategic Plan. We stress that we are not just this team of core staff. Rather, our strength and achievement are in the larger family of colleagues from across our partner institutions and stakeholders who join us in our work. My thanks to everyone in-volved in any way in our activities during 2017.

CEO’s Statement

As an entity, we are of and for our partner institutions, and success in any of our endeavours and work streams can only be achieved by working in partnership together and with stakeholders.


Dr Pat O’MahonyChief Executive, Clinical Research Development Ireland

Funding for the operation of CRDI comprises a core funding commitment from each of our 5 partner academic institutions which is greatly appreciated, and programmatic/grant funding from all the various partners outlined in the chapters that follow. My thanks to all for the continued support which enables our work as we strive to meet our mission “to advance patient care and health service delivery by supporting the development of clinical and translational research”. I commend this report to you the reader. You will see outlined details on a wide range of activities and highlights of key achievements and events. In looking forward to 2018 and beyond, I stress the partnership model

of our engagements, our ambition that the University of Limerick and Queens University Belfast will formally join the partnership, enhanced engagement of all stakeholders in building the infrastruc-ture and supports required for clinical and translational research, and engage-ment and support of all funders, policy makers and the health care delivery system. It is widely accepted by all that the better developed our clinical research system is, the better the outcomes for all stakeholders from patients to healthcare providers, academia, the life sciences sector and the enterprise economy. CRDI looks forward to supporting the development of the research system and to cooperating and collaborating with all in advancing our common interests.

It is widely accepted by all that the better developed our clinical research system is, the better the outcomes for all stakeholders form patients to healthcare providers, academia, the life sciences sector and the enterprise economy.


CRDI Structure & Governance

CRDI was formed in response to the need to create a critical mass of excellence in molecular medicine research and education in Ireland and to deploy a clinical research infrastructure to facilitate medicine into better healthcare provision. CRDI was known as Molecular Medicine Ireland when it was formally incorporated as a not-for-profit company by the aforementioned partner institutions in April 2008. MMI was preceded by the Dublin Molecular Medicine Centre, created in 2002 by Trinity College Dublin and University College Dublin, and joined in 2005 by the Royal College of Surgeons in Ireland. CRDI is funded by the five academic insti-tutions along with programme funding from a number of sources including the Health Research Board, Enterprise Ireland, Wellcome Trust, Science Foundation Ireland, Irish Cancer Society and the Health Service Executive. CRDI is governed by a Board of Directors (see Page 12), comprising two representatives from each partner institution and external appointees from the public and industry sectors. Queen’s University Belfast is represented at CRDI Board meetings in an observer capacity. At the end of 2017, the core business of CRDI was supported by a staff of 18 people (see details on Page 52).

Clinical Research

TranslationalResearch

CEO’sOffice

Education &Development

Finance

CRDIBOARDCRDIBOARD

CEO

CLINICAL RESEARCH DEVELOPMENT IRELAND (CRDI) IS A LEADING IRISH ACADEMIC RESEARCH BODY, ESTABLISHED BY NUI GALWAY, ROYAL COLLEGE OF SURGEONS IN IRELAND, TRINITY COLLEGE DUBLIN, UNIVERSITY COLLEGE CORK AND UNIVERSITY COLLEGE DUBLIN, THEIR MEDICAL SCHOOLS, ASSOCIATED ACADEMIC HOSPITALS AND CLINICAL RESEARCH FACILITIES.


CRDI Strategy

CRDI STRATEGIC VISION:

To be an effective and innovative force for the development of clinical and translational research in Ireland, and to be recognised, both nationally and internationally, as a model of organisational excellence focused on advancing evidence-based patient care and network coordination.

CRDI MISSION STATEMENT:

To advance patient care and health service delivery by supporting the development of clinical and translational research across our partner academic institutions, their medical schools and associated hospitals.

CRDI VALUES:

• Acting in the best interests of patients• Operating to the highest standards of

scientific rigour and quality• Behaving with integrity and impartiality• Promoting research, innovation, openness

to change and continual learning• Treating stakeholders and each other with

dignity and respect at all times

StrategicGoals

Advance the development of a sophisticated, coordinated clinical and translational re-

search partnership across our partner academic institutions,

their medical schools and associated hospitals.

Develop and support clinical trials delivery.

Develop and support education

and training.

Develop and support clinical

and translational research infrastructure

and delivery.

Develop capability across network

partners and CRDI.

Advocate for adequate funding

for the development of clinical and translational

research.

CRDI Board

Thomas LynchChair

Professor Willard DereProfessor of Internal Medicine,

University of Utah

Professor Joe EustaceProfessor of Medicine at University College Cork, Consultant Nephrologist, Cork Uni-versity Hospital and Director of the HRB

Clinical Research Facility, Cork

Professor Orla FeelyVice-President for Research,

Innovation and Impact, University College Dublin

Professor Michael GillHead of School of Medicine and

Professor of Psychiatry, Trinity College Dublin

Professor Orla HardimanProfessor of Neurology and Consultant

Neurologist at the National Neuroscience Centre, Trinity College Dublin

Professor Lokesh JoshiVice-President for Research,

NUI Galway



Professor Dermot KennyProfessor of Cardiovascular Biology and

Director of Clinical Research Centre, Royal College of Surgeons in Ireland

Professor Anita MaguireVice-President for Research & Innovation,

University College Cork

Professor Patrick MurrayProfessor of Clinical Pharmacology and Dean

and Head of the School of Medicine and Medical Science, University College Dublin

Professor Martin O’ DonnellProfessor of Translational Medicine, NUI

Galway and Associate Director of the HRB Clinical Research Facility Galway

Professor Ray StallingsDirector of Research and Professor of Cancer Genetics, Royal College

of Surgeons in Ireland

Professor Mike ClarkeObserver for Queen’s University, Belfast

Chair of Research Methodology and Director of the All-Ireland Hub for Trials Methodology

Research, Queen’s University Belfast


Pictured at the Launch of CRDI on 2 October 2017: Dr Pat O’Mahony, Chief Executive of CRDI, Mr Simon Harris TD, Minister for Health and Mr Thomas Lynch, Chair of CRDI


On Monday 2 October 2017, Clinical Research Development Ireland (CRDI) was unveiled by Minister for Health, Simon Harris TD, as the new name for Molecular Medicine Ireland in the stately and historic surroundings of Farmleigh House. CRDI’s ambitious Strategic Plan 2017 – 2021 was also launched at the event, which attracted key representatives from the Irish and international academic, public and private sectors. CRDI is a leading Irish academic research body, formed as a not-for-profit partnership with charitable status, by NUI Galway, Royal College of Sur-geons in Ireland, Trinity College Dublin, University College Cork and University College Dublin, their medical schools, associated academic hospitals and clinical research facilities. The mission of CRDI is to advance patient care and health service delivery by supporting the development of clinical and translational research across our partner academic institutions, their medical schools and associated hospitals.

Dr Pat O’Mahony, Chief Execu-tive of CRDI, opened proceedings by welcoming everybody and thanking the Minister, the speakers and all in atten-dance for coming. On introducing the new brand mark for CRDI, he explained that the decision by the Board to relaunch the partnership under a new brand and to devise a new strategic plan was timely given the extensive changes in the exter-nal environment. Dr O’Mahony later introduced the new five-year strategy which outlines the next phase in the development of this unique research collaboration. He empha-sised the importance of partnership with academia, the health sector and industry both in Ireland and abroad, stating that the successful delivery of the strategy was contingent on the combined efforts of all. Respecting the past achievements of this fifteen-year partnership, he said our unique position continues to be that: “....as the combination of the partners, we mobilise the combined strength of all our partner academic institutions, their medical schools and associated hospitals, with the aid of a central

co-ordinating entity.” Before officially unveiling the new brand identity for CRDI, Minister Harris thanked the audience for their contribu-tion to research in Ireland and added that the Government recognises “the importance of health research for the creation of a fairer, more efficient health system and for the delivery of better health outcomes”. He proceeded to acknowledge CRDI as a major player in the delivery of many national health re-search initiatives and infrastructures and commended the organisation by noting that: “As a small country, a functioning clinical research system needs to be based on well aligned components working together to provide integra-tion of processes, infrastructure and people and I know CRDI is well placed to support this.” Mr Thomas Lynch, Chairman of CRDI, outlined the evolution of what he termed a “novel collaboration”. It was founded in 2002 by Professor Dermot Kelleher, formerly of Trinity College Dublin, and Professor Hugh Brady, formerly of UCD, at the suggestion of the Higher Education Authority who

CRDI LaunchCLINICAL RESEARCH DEVELOPMENT IRELAND IS LAUNCHED BY MINISTER FOR HEALTH, SIMON HARRIS TD

As a small country, a functioning clinical research system needs to be based on well aligned components working together to provide integration of processes, infrastructure and people and I know CRDI is well placed to support this.


at that time had allocated substantial funding specifically for collaborative research initiatives under the Programme for Research in Third Level Institutions (PRTLI). Initially known as the Dublin Molecular Medicine Centre, the part-nership grew when the Royal College of Surgeons in Ireland joined in 2005. It was transformed into a national entity with the accession of NUI Galway and University College Cork and relaunched as Molecular Medicine Ireland in 2008. Mr Lynch revealed that since inception, the CRDI partnership had se-cured in excess of €150m in funding for collaborative programmes in clinical and translational research and in education and training across the constituent part-ner institutions. Sources of this funding include PRTLI, Health Service Execu-tive, Health Research Board, Enterprise Ireland, Wellcome Trust, Science Foun-dation Ireland and European Framework Programme 7. Looking to the future, Mr Lynch welcomed the important CRDI strategic objective of expanding the partnership to include the University of Limerick in 2018 and Queen’s University Belfast as soon as possible thereafter. CRDI was honoured to welcome back as guest speaker, founder and former board member, Professor Der-mot Kelleher, Dean of the Faculty of Medicine at the University of British

Columbia. Reflecting on the organisa-tion’s genesis, Professor Kelleher said that while it was initially viewed as “culturally a difficult thing for two universities to do at that time”, by joining forces, TCD and UCD were able “to maximise our critical mass, pull together our technology platforms and work together more effectively”. The prevailing consensus in the ear-ly 2000s was that academic institutions in Ireland needed to collaborate in order to compete internationally. As a result of this original joint venture, made possible under PRTLI Cycle 2, together with the subsequent membership of RCSI, NUI Galway and UCC, Professor Kelleher declared that the Irish medical research landscape had been transformed beyond recognition and there had been “a big change in our level of pride and interna-tional visibility”. The fifth and final speaker was Pro-fessor Martin O’Donnell, CRDI Board Director, Professor of Translational Medicine at NUI Galway and Director of HRB CRF Galway. Addressing the opportunities and challenges facing CRDI, Professor O’Donnell said, “The name change was about maintaining the phi-losophy {of the partnership} but expanding the activities and accommodating a change in the clinical research environment within Ireland”. While it was important to consolidate existing partnerships, he proposed that “CRDI has a role in identifying and articulat-

ing areas of collective opportunity” in a wider context that would include the hospital groups, primary care sector, industry and international companies as well as public and patient representative bodies. For the future development of clinical research, Professor O’Donnell advocated for greater and more sustain-able Government investment and he recommended that a more proactive yet focused approach be taken by clinical researchers in terms of specialist areas in which Ireland has a significant advan-tage. He also stressed the importance of embracing and harnessing technology and of educating the next generation of researchers that not only includes clinicians but research nurses, project co-ordinators and biostatisticians. A question and answer session with the panel of speakers followed before closing remarks by the Chairman, Tom Lynch. For further information on the launch of CRDI and to view the launch video please go https://www.crdi.ie/launch-clinical-re-search-development-ireland/

The name change was about maintaining the philosophy but expanding the activities and accommodating a change in the clinical research environment within Ireland

Ireland is internationally recognised for conducting innovative high quality clinical research for the benefit of people’s health and the economy.

VISION:

MISSION:

To advance healthcare by enabling a coordinated system with the specialist skills, expertise and infrastructure to design, conduct and analyse clinical trials and other intervention studies in Ireland, undertaken by networked clinician investigators and/or industry.

The Health Research Board Clinical Research Co-ordination Ireland (HRB CRCI) is a collaborative partnership of the university-based clinical research facilities/centres (CRF/Cs) and their associated hospitals. It was established in 2015 as an independent, integrated na-tional clinical research network, to pro-vide centralised support in the conduct of multicentre clinical trials for both academia and industry across Ireland. It is funded by extramural grants from the HRB and Enterprise Ireland (EI), supported by the five largest universities in Ireland and it is hosted by CRDI. HRB CRCI is funded by the HRB for an initial 6-year period from May 2015 to April 2021, with an interim re-view after 3 years. To ensure continuity of funding and a smooth transition, the Interim Review Report was submitted early in July 2017 and this was followed by an international panel review process. The review was completed throughout 2017 with increased continued funding confirmed for a second phase to run from May 2018 to April 2021. The HRB CRCI team were involved in this review process throughout 2017.


1. To enhance Ireland’s capacity for conducting innovative high quality clinical research for the benefit of people’s health and the economy

AIM OF HRB CRCI

2. To advance the care of patients by enabling a connected and coordinated Clinical Trial Network.

3. To provide the skills, expertise and infrastructure to design, conduct and analyse multi-centre clinical trials involving human participants in Ireland.

4. To support both academic and industry initiated clinical trials involving pharma-ceuticals, neutraceuticals or clinical care pathways, as well as, clinical investigation of medical devices.


The HRB CRCI central office provides over-arching support and expertise to academia and industry, through a range of services and activities that have been developed to help address the unmet needs in clinical research in Ireland. CRDI provides corporate support services to the central office and the part-

ner CRF/Cs provide the infrastructure, phys-ical space and facilities, experienced research and specialist support staff and the necessary quality and oversight of programmes that are critical for the successful conduct of world-class patient-focused research.

HRB CRCI SERVICES

1. Signposting: Primary point of contact

for clinical innovation and research, facilitating industry

and academia.

2. Study feasibility: Streamlined process with coor-dination and oversight through the central office and dedicated resource in the CRF/Cs to nav-igate local systems and engage with investigators, ultimately leading to efficient and timely

identification of sites.

3. Regulatory and Ethics: Management of the application

process, including prepara-tion and submission of study

documents when feasible. This service can be delivered locally or by the CRF/Cs and/or by

the central office.

4. Study start-up: Range of supports available

to optimise start-up activities, including central coordination and dedicated resource in CRF/Cs accelerating all aspects of the

process at the site level.

5. Recruitment: Tracking/monitoring of

recruitment targets. Collation of metrics from across CRF/Cs and

provision of advisory support.

6. Audit and Monitoring: Oversight of study conduct

through risk-based plans and activities, with reporting to sponsor. This service can be

delivered locally by the CRF/Cs or centrally.

7. Quality: Ensured through a team of

quality managers located across the central office and CRF/Cs, facilitating best practice and

harmonisation across the network.

8. On-line services: Provision of resources,

including templates, guidance and signposting to training and

education programmes, as appropriate.

9. Consultancy & Advisory: Consultation on regulatory pathways and provision of

advice on conduct of clinical research in all fields.

10. Promotion: Ambassadors for Irish clinical

innovation and research, nationally and internationally.


HRB CRCI STRUCTURE

CONTACT INFORMATION

Dr Fionnuala Keane

Tel: +353 1 4779819

Anna Shevlin

[email protected]: +353 14779815

Prof Joe EustaceHRB CRCI Chair, HRB CRFC Director

[email protected] Tel: +353 21 4935150

Fionnuala Gibbons

Tel: +353 14779825

CONTACT INFORMATION

Dr Fionnuala Keane

Tel: +353 1 4779819

Anna Shevlin




Fionnuala Gibbons

Tel: +353 14779825

CONTACT INFORMATION

Dr Fionnuala Keane

Tel: +353 1 4779819

Anna Shevlin




Fionnuala Gibbons

Tel: +353 14779825


HRB CRCI WORKING GROUP ACTIVITIES1. Quality Working Group (QWG) consists of the Quality and Regulatory Af-fairs Managers (QRAMs) from across the centres and is chaired by the HRB CRCI QRAM. In 2016, the QWG developed a Mutual Recognition Policy and in 2017 it implemented a mutual recognition scheme through peer review of the quality manage-ment systems of each CRF/Cs. The policy document specifies minimum expectations for 13 categories of the CRF/C Quality Management System by which the peer review visit assessments were completed. The QWG also operated a horizon scan-ning programme in 2017 which involved monitoring the upcoming changes to reg-ulations and directives that have an impact on clinical research: for example, the new Clinical Trial Regulation (536/2014), Gen-eral Data Protection Regulation (GDPR) (EU) 2016/679 and the Medical Device Regulation (EU) 2017/745, etc., were all reviewed and assessed for their implications to the network.

2. Feasibility and Study Start-up Working Group (SFSWG) consists of the HRB CRCI Feasibility and Study Start-up Facilitators at each of the centres and is chaired by the HRB CRCI Clinical Trial Liaison Manager. The mission of the SFSWG is to facilitate cooperation and

sharing within the HRB CRCI partner-ships with respect to efficient delivery of investigator and site selection and study start-up and first patient first visit time-lines. In 2017, this group together with the core office staff delivered on the HRB CRCI Feasibility Programme, tracking metrics. The HRB CRCI-hosted CRF Manager system was adapted to allow for future study progress monitoring.

3. Budget Working Group (BWG) consists of personnel from HRB CRCI and the CRF/Cs who work together to stream-line and standardise the process for clinical trial costings and budget development nationally. In 2017, the group developed a checklist for a clinical trials costs guide document in collaboration with the QWG. This document is being used by the HRB for their recent Definitive Intervention and Feasibility Awards call and is also available for use on the HRB CRCI website.

4. Clinical Research Patient Public Involvement Working Group (CR-PPI-WG) consists of representatives from the CRF/Cs, clinical trial networks (CTN’s), PPI interested organisations, the Irish Platform for Patient Organisations, Science and Industry (IPPOSI) and the HRB CRCI. The mission of the working

group is to facilitate cooperation and sharing within the member organisations with respect to PPI knowledge, resources, training and innovation. In 2017, a central repository for sharing PPI tools and infor-mation across the network was developed by HRB CRCI.

5. Legal Working Group (LWG) consists of representatives from the legal offices of the university partners. The primary mission of the group is to develop a two-tier Confidential Disclosure Agreement (CDA) process for clinical research in Ireland. During 2017, considerable efforts were made by the group to develop the necessary templates and the group aims to complete their development and implement the new process in 2018.

6. Pharmacovigilance Working Group (PWG) comprises the pharmacovigilance officers from each of the CRF/Cs. The purpose of the group is to facilitate cooperation and sharing within the HRB CRCI partnerships with respect to pharmacovigilance. This group was newly established in Novem-ber 2017 and will progress and develop in 2018.


The National Study Feasibility Pro-gramme operated by HRB CRCI was established in August 2015. The programme connects academic and industry sponsors with potential inves-tigators in Ireland. HRB CRCI acts as the central channel through which study feasibility assessments can be distributed and completed efficiently. The HRB CRCI Investigator Member-ship Database, CRF/C network and clinical research networks are utilised to significantly reduce the time taken to identify investigator sites and to assess study feasibility. The programme is actively managed to ensure feedback to the applicant is made within two weeks of initial receipt of the feasibility request. Dedicated HRB CRCI staff, based in each CRF/C, work to identify local investigators and to support these investigators with the completion of their feasibility assessment. Types of assessments undertaken include Key Opinion Leader assess-ments, Investigator Identifications, with and without completion of Feasibility Questionnaires. The initial programme target to process 20 feasibility requests over a duration of 24 months (i.e. to Au-gust 2017) was dramatically surpassed. By the end of 2017, 29 months following

HRB CRCI NATIONAL STUDY FEASIBILITY PROGRAMME

The graphic below summarises the Feasibility Programme Metrics for the Year 2017:

project commencement, 148 feasibility assessments were processed, 84 in 2017, with interest expressed by investigators in 117 of these studies (79%) and 33 studies classified as proceeding at Irish sites (22%). Investigators expressed interest in 57 studies through the feasibility service with 16 studies progressing to the next stage in 2017. For further details on how to place a feasibility request with HRB CRCI please see https://www.hrb-crci.ie/services/study-feasibility/

By the end of 2017, HRB CRCI had engaged with over 440 investigators cov-ering 36 secondary care hospitals and 15 primary care centres across 34 specialties. The type of companies that use the ser-vice include pharmaceutical companies (n=15), clinical research organisations (n=15) and clinical trial networks (n=6).

In 2017 the HRB CRCI processed 84 studies for feasibility with 16 new studies proceeding to next start across the centres.


HRB CRCI offers two types of member-ships – one for Investigators (Investigator Membership) and one for all clinical research personnel working in hospitals, practices and academic organisations (Standard Membership). Through this, members are kept informed of HRB CRCI activities and clinical research op-portunities within their clinical interest area. By end of 2017, 111 Investigators and 49 clinical personnel were registered as HRB CRCI members.

Further details on how to become a member of HRB CRCI can be found at https://www.hrb-crci.ie/about/mem-bership/

HRB CRCI MEMBERSHIP

In 2017, HRB CRCI assumed support for the implementation of the CRF Manager system in Ireland. This system is used at CRF/Cs across the country to:

• Manage research study setup and approval• Plan and record patient recruitment and visit scheduling• Resource allocation, costing and invoicing• Report metrics on studies, patients and costs

The CRF Manager system was developed at the University of Edinburgh and is used at more than 50 clinical research sites across the UK. In Ireland, the system operates on a single cloud-based installation, with 110 active users in seven CRF/Cs. The IT Manager at HRB CRCI provides first line support to all sites that use the CRF Manager system, with second line support being provided by the development team at Edinburgh. In 2017, the IT Manager attended two meetings of the UK user group on behalf of HRB CRCI. These provide a forum for making decisions on further enhancements and development of the system. Changes to the Irish implementation were made as a result of these decisions in order to facilitate the gathering and reporting of Ireland-specific metrics.

CRF MANAGERRESEARCH STUDY MANAGEMENT SYSTEM


During 2017, HRB CRCI took over support for existing data collection and eCRF facilities for academic studies which had previously been part of the Dublin Centre for Clinical Research, a former CRDI programme. There were eight such studies actively recruiting patients in several disease areas includ-ing ophthalmology, prostate cancer, infectious disease, cardiovascular disease, auto-immune disease and renal disease. HRB CRCI supported facilities for the collection, verification, query and reporting of patient study data.

DATA MANAGEMENT SUPPORT

In 2017, HRB funding to the IRNN was facilitated through the HRB CRCI grant. A funding application prepared by IRNN and HRB CRCI and submitted via CRDI to the HRB in 2016 was approved in 2017. Administration of the IRNN HRB funding is via CRDI with oversight by HRB CRCI, CRDI and members of the IRNN Management Team. HRB CRCI promotes IRNN as part of its signposting service and online database on an ongoing basis. The HRB CRCI COO also chaired the morning session of the IRNN Annual Conference in 2017.

HRB CRCI SUPPORT FOR THE IRNN

The Enterprise Ireland (EI)-funded role of Clinical Industry Liaison Of-ficer (CILO), based in HRB CRCI, was established to support indige-nous researchers, medical device and biotechnology companies, including start-ups, SMEs and multinationals, in the development of new medical devices and diagnostics. A key focus of the role was on the provision of clinical research advice and guidance to assist clients in the development, commercialisation and post-market-ing of their product. During 2017, the CILO collab-orated with key stakeholders in the Irish Medtech sector and attended relevant training courses to assess the impact of the revised medical

devices regulatory framework on the requirements for medical device clinical research and commerciali-sation in Ireland with a view to the development and provision of rele-vant information, training and tools to support the Irish Medtech sector. The CILO also developed and facilitated training programmes, including the Good Clinical Practice for Medical Device Development based on the ISO14155:2011 standard as well as a number of introductory courses on medical device development planning. The CILO post became vacant in July 2017. Funding for the post was approved recently and will shortly be re-advertised.

HRB CRCI SUPPORTS IRISH INDUSTRY


EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN)

HRB CRCI actively participated in Eu-ropean Clinical Research Infrastructure Network (ECRIN) activities and events throughout 2017. ECRIN is a not-for-profit, intergovernmental organisation that supports the conduct of multina-tional clinical trials across Europe. Since 2013, ECRIN has had the legal status of a European Research Infrastructure Consortium (ERIC). It is based in Paris and works with European Correspon-dents across Europe, national networks of clinical trial units (CTUs), as well as numerous European and international stakeholders involved in clinical research. HRB CRCI has been acting as an unofficial Observer to ECRIN over the last 3 years and during this time has received a number of requests to provide supports for ECRIN- endorsed H2020 applications. This included monitoring support and services provided by the QRAMs at HRB CRCI, HRB CRF Cork and the RCSI CRC relating to the

development of the ECRIN regulatory databases for Investigational Medicinal Products IMP and medical device trials. During 2017 the HRB CRCI QRAM represented HRB CRCI through attendance at European Cor-respondent teleconferences, scientific meetings and face-to-face meetings in an observer capacity. The QRAM also attended the ECRIN Summer School in Norway in September, while the HRB CRCI COO attended the ECRIN An-nual Meeting in Lisbon in May and the assembly of members meeting in Parisin December 2017. It is anticipated that Ireland will become a full member of ECRIN in 2018 and will be represented by a fully funded European Correspondent, based in HRB CRCI.

HOW ECRIN WORKS WITH NATIONAL PARTNERS

INTERNATIONAL NETWORK ACTIVITIES


INTERNATIONAL NETWORK ACTIVITIESUK CLINICAL RESEARCH FACILITY NETWORK

The HRB CRCI QRAM became a member of the UK Clinical Research Facility Network Quality Assurance (UKCRFN QA) workstream in 2017 and attended the first meeting of the group in the Edinburgh CRF in October 2017. The QA workstream aims to foster and facilitate collaborative working and shar-ing of good practice to develop common QA systems in clinical research facilities across its network. Activities include the organisation of training sessions at the UKCRFN annual conference on relevant QA topics, developing a core set of SOPs for the establishment of new CRFs, the establishment of a QA forum and the de-velopment of inspection readiness tools. As full members, HRB CRCI can both learn from and contribute to the activities of this group.

CLINICAL RESEARCH INITIATIVE FOR GLOBAL HEALTH

In January 2017, HRB CRCI signed up as Ireland’s representative of the Clinical Research Initiative for Global Health (CRIGH), enabled by funding from the HRB. CRIGH aims to improve interna-tional collaboration, coordination, and efficiency in clinical trials. This initiative is coordinated internationally through ECRIN with collaborators from across the globe.

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SOCIAL MEDIA AND COMMUNICATION HIGHLIGHTS:

HRB CRCI INTERNATIONAL CLINICAL TRIALS DAY 2017


Celebrating International Clinical Trials Day

The first national seminar to celebrate International Clinical Trials Day was hosted by HRB CRCI on 15 May 2017 in the historical Round Room at the Mansion House in Dublin. With the theme, “Improving Patient Health Through Clinical Research”, the seminar highlighted how improved access to clinical trials can increase health benefits for patients, and showcased some of the clinical research being conducted in Ireland. An audience of some 170 delegates heard from Ireland’s leading experts about their involvement in clinical re-search in hospitals and clinical research facilities and centres around the country, and from patients who related their posi-tive experiences as participants of clinical trials. A key feature of the event was the launch of a calendar outlining the events taking place across the country to mark

International Clinical Trials Day. A number of posters were exhibited, highlighting a cross-section of research activities undertaken by individual researchers. International Clinical Trials Day was initiated in 2005 to mark the day when the Scottish naval surgeon, James Lind, started his famous clinical trial on scurvy in 1747, and laid the foundation for mod-ern clinical research. It has been celebrat-ed every year since 2005, on or around 20 May, and it provides the opportunity for organisations, clinical research profes-sionals, and the public to acknowledge the achievements that result from clinical research. Professor Joe Eustace, Chairperson of HRB CRCI, said, “It is widely acknowledged that clinical research not only saves lives but can enhance patients’ lives in the longer term as new products come to market. Those countries that have embraced research as part of their national

healthcare system have also witnessed better health outcomes for their patients. Ireland has established a research community that complies with the quality and regulatory standards required to safeguard patients whilst enabling new innovations to be efficiently tested. This infrastructure has the potential to be up scaled now to take best advantage and position Ireland as a significant hub for clinical research for the future”. HRB CRCI plans to host Internation-al Clinical Trials Day annually and hopes that it will become an important event in the Irish clinical research calendar.

An important message communicated by HRB CRCI at the event highlighted that investment in Irish clinical infrastructure was showing progress with 197 trial sites opened across its research centres in Ireland in 2016 compared to 143 in 2014.


Corporate Enabling of Clinical Research Initiative

In 2017, Irish academic institu-tions and funders came together to identify and address the challenges faced by the academic institutions when sponsoring and managing clinical trials particularly with regard to the areas of governance, contracts and insurance. As a result of this engagement, the project, Corpo-rate Enabling of Clinical Research (CECR), was established and is hosted by CRDI. The rationale for this initiative was the belief that the difficulties experienced by academics would be better addressed in a cooperative manner and with input from all stakeholders across the health sector, academia, funding and regulatory bodies.

Expected Outcome: Achieving greater cooperation with the health sector will ensure that the clinical research strategies of academic institutions will be better aligned with the mission of the health sector to improve patient outcomes and healthcare delivery.

CHALLENGES

A detailed Action Plan was developed, addressing the following challenges:

• A need for engagement and cooperation between academic institutions and the health sector in relation to the governance, management and planning of clinical research.

• The requirement to document and understand the responsibilities of the academic sponsor of clinical research and the associated legal, regulatory and governance requirements to enable appropriate support and oversight.

• The need for transparency and clarity on roles and responsibilities both in the hos-pital system and in academic institutions when carrying out clinical research.

• The requirement to achieve consistency of contractual approaches across the academic and health sectors and agree a more timely and efficient interinstitutional approval pathway which enables smoother contracting processes and ensure that clinical studies begin within a reasonable time frame.

• The requirement for the academic sector to develop and agree, with the health sector, a national contractual framework for the governance and management of clinical research.

• The need to provide clarity on State indemnity and identify the gaps that need to be filled via commercial insurances.

• The need to provide support and training for clinicians engaging in clinical research and recognise the importance of the role played by hospitals in clinical research.

AIMS

• To find better informed and more effective solutions

• To deliver a more coordinated and efficient use of resources

• To enable a more targeted use of funding• To better manage risks• To deliver greater patient safety and a

more agile implementation of studies• To deliver clinical research of the

highest quality.

EXPECTED OUTCOMES

• Consistency of contractual approaches across the sector.

• A cooperation framework between academic institutions and the health sector.

• An institutional pathway for the sponsorship of clinical studies that defines governance, management and approval requirements.

• Clarity on and consistent affiliation of indemnity under the Clinical Indemnity Scheme

• A consistent approach across academic institutions around procurement of commercial insurance.


CECR STRUCTURE

The CECR initiative is co-chaired by Ms Nora Geary of University College Cork, Dr Paola Della Porta of Royal College of Surgeons Ireland and Dr Pat O’Mahony of Clinical Research Development Ireland. The steering group is made up of all members of the CECR initiative which meets on a quarterly basis. The governance and leadership working group is made up of all the co-chairs of the working groups and senior management from multiple partner organisations. There are six working groups (WGs), namely, governance and leadership, spon-sorship and quality, insurance, contracts and legal, budgets, and clinician engagement, support and development, that have been set up to address the challenges identified. See Figure 1 for details.

STAKEHOLDERS

The CECR initiative comprises over 50 members from the stakeholder organisa-tions, with expertise ranging from clinical research management and support to

quality and regulatory affairs, financial, risk management, governance and legal affairs. The organisations include the five CRDI partner institutions, NUI Galway, Trinity College Dublin, the Royal College of Surgeons in Ireland, University College Cork and University College Dublin, as well as the University of Limerick, Maynooth University, Clinical Research Development Ireland, HRB CRCI, Health Research Board, State Claims Agency, Willis Towers Watson, Cancer Trials Ireland, Health Ser-vice Executive and Enterprise Ireland. A number of other stakeholders will be joining the initiative over the coming months. The partner organisations have con-tributed financially towards the recruitment of a dedicated project manager, to ensure delivery of the project. Moreover, the part-ner organisations have made a substantial in-kind contribution with the assignment of key members of their staff to the planning and development of the project and partici-pation in the working group activities. The project is expected to be completed by December 2018. Any actions left out-standing at that time will be reviewed and recommendations made for their resolution.

MANAGEMENT STRUCTURE:

STEERING GROUPCO-CHAIRS

PROJECT MANAGER

GOVERNANCE & LEADERSHIP GROUP

CONTRACTS & LEGAL WG

SPONSORSHIP & QUALITY WG

CLINICIANS ENGAGEMENT, SUPPORT & DEVELOPMENT WG

BUDGETSWG

INSURANCEWG

CORPORATE ENABLING OF CLINICAL RESEARCH

Figure 1.

Co- chairs of the CECR initiative (L-R) Ms Nora Geary (UCC), Dr Pat O’Mahony (CRDI) and Dr Paola Della Porta (RCSI)


By the start of 2017, the Irish Prostate Cancer Outcomes Research (IPCOR) study had made significant progress in establishing a national registry of men, newly diagnosed with prostate can-cer. The registry prospectively collects comprehensive and high-quality clin-ical information and patient-reported outcomes measurements (PROMs) about men from the time of diagnosis and throughout treatment. The research aims to provide evidence-based data and recommendations to clinicians, hospitals, decision-makers and the National Cancer Control Programme that promote im-provements in care. The project is managed by the Translational Research Manager for the IPCOR Programme at Clinical Research

Development Ireland and is carried out in collaboration with National Cancer Registry Ireland (NCRI) and the Clinical Research Facility in Galway (CRFG). The study is funded by the Movember Foundation, in partnership with the Irish Cancer Society.

CLINICIAN RECRUITMENT

Sixty-seven clinicians were signed up to the IPCOR study and were helping to facilitate the collection of data on prostate cancer patients in their hospitals. Clinician support and enthusiasm for IPCOR is essential to its success and to enable our goal of assessing the processes and quality of care and the health-related outcomes of men diagnosed with prostate cancer.

Irish Prostate Cancer Outcomes Research

Four IPCOR research officers are employed by the NCRI and are responsible for the registration of men and collection of their clinical data in our 15 participating hospitals across Ireland. During 2017, 2946 men were registered bringing the total registered into the database to 4522 men. Preliminary analysis of our data

indicates that we have comprehensive coverage across Ireland from both the public and private hospital sectors. This population-based data will allow for the assessment of between-hospi-tal and regional differences in clinical and patient-reported outcomes in order to inform initiatives to ensure parity of access and standards of care nationally.

Figure 1.

Distribution of patients registered

by HSE area

Figure 2.

Distribution of patients by hospital type

CLINICAL DATA COLLECTION

Table of clinician recruitment

Speciality No. Invited No. Signed up % Signed up

Urologists 47 42 89

Medical Oncologists 14 11 79

Radiation Oncologists 16 14 88

Total 77 67 87

Public

Private

Ireland South

DublinMid-Leinster

DublinNorth-East

IrelandWest


PROMS PILOT STUDY

A pilot study for the PROMs research was conducted during 2016 and 2017. Men registered in our database were invited to complete internationally vali-dated quality of life questionnaires before their treatment began. Responses were received via post as well as through our electronic PROMs collection tool on the IPCOR website. Men who consented to participate and return the questionnaires will be followed up annually to assess their quality of life while being treated for prostate cancer. Procedures requir-ing improvement were identified during the pilot study and these improvement initiatives will be implemented for the na-tional roll out of the PROMs study. The PROMs study will assess men’s experi-ences of care, functional and psycholog-ical wellbeing, and health-related quality of life across the cancer journey.

RECRUITMENT

In September 2017, a research analyst was recruited and is responsible for analysing IPCOR data and producing our public annual reports on national prostate cancer outcomes to disseminate to the public, including cancer patient support groups and patients themselves. The analyst who is based at HRB CRFG is also developing benchmarking reports for clinicians and hospitals.

IPCOR APP

PatientMPower, a digital healthcare com-pany, developed a patient support app for IPCOR in 2017. The app development was funded by an award to IPCOR from Astellas Ireland. The app is designed to be a digital health record for prostate cancer patients where they can record upcoming appointments, symptoms and concerns they would like to discuss with their clinician, monitor their activity levels and compare their outcomes to the national averages of men undergoing similar treatments.

The IPCOR team also submitted a successful application for funding to Ipsen Pharmaceuticals and Janssen Ireland for the development of patient support videos. Seven videos have been recorded in collaboration with ARC Cancer Centre in the areas of prostate cancer-specific exercises and fatigue management. The videos will be made available on the app as well as the IPCOR website.

You can visit the IPCOR website at: www.ipcor.ieOr follow us on Twitter: @IPCOR_Ireland

TRUENTH GLOBAL REGISTRY

IPCOR was successful in its applica-tion to participate in the Movember Foundation funded TrueNTH Global Registry. Globally, prostate cancer treatment and outcomes for men vary according to where they live, their race and the care they receive. The TrueNTH Global Registry project was established as an interna-tional registry monitoring care provid-ed to men with localised prostate can-cer and aims to significantly improve the physical and mental health of men treated for prostate cancer. IPCOR will transfer both clinical and PROMs data to the TrueNTH Global Registry which is hosted at Monash University, Melbourne, Australia. In total, 25 Local Data Centres representing 113 participating sites across 13 countries will contribute to the registry. The project will analyse variations between sites and countries to understand key drivers that deliver the best outcomes. The Translational Research Manager for the IPCOR Programme attended the TrueNTH International Meeting in Vancouver, Canada in June 2017 to meet with all the other collaborators of this initiative.


The aim of iPROSPECT is to find biological markers and indicators in men with advanced prostate cancer which correlate with treatment responses and which will aid future personalised treatment decisions for patients with advanced prostate cancer.


iPROSPECT

The Irish Programme for Stratified Pros-tate Cancer Treatment (iPROSPECT) study is programme-managed by CRDI and is funded by the Movember Founda-tion, in partnership with the Irish Cancer Society. In its fourth year of operation in 2017, iPROSPECT is the first long-term, multicentre clinical study for advanced prostate cancer in Ireland. The aim of iPROSPECT is to find biological mark-ers and indicators in men with advanced prostate cancer which correlate with treatment responses and which will aid future personalised treatment decisions for patients with advanced prostate cancer. Establishing a study of this scale and complexity, conducted through a national cooperative network, has been a significant achievement.

STUDY DESIGN

iPROSPECT was set up as a longitudi-nal clinical study of advanced prostate cancer patients, conducted by Cancer Trials Ireland. There are three associated research projects that are aligned to the overall aim of the study and that utilise patient samples and data from the study. In total, 55 patients from eight hospitals across Ireland were recruited to the study. The biobank used for the study is located in St. James’s Hospital Dublin and stores serum, plasma and isolated circulating-tumour cells from the 55 study patients, collected at multiple time-points, accounting for 246 individual sample collections. Biopsy tissue from metastatic tumours has been collected from 18 patients. Clinical data is collected by Cancer Trials Ireland from the hospital sites at each sample collection time-point. Sample and data collection will continue until all patients finish their treatment.

RESEARCH PROJECTS

The three research projects were designated to utilise the iPROSPECT biobank. To date, Project 1 has examined how prostate cancer spreads to the bone, exploring how the interaction of bone and cancer cells affects therapeutic drug response. Projects 2 and 3 are identifying new clinical tests to determine which treatments best suit an individual patient, thus personalising prostate cancer treat-ments. The novel data generated by these projects will lay the foundation for the next generation of diagnostic and pre-dictive tests and new therapeutic targets. This will result in enriched personalised therapeutic options and improved surviv-al rates for patients with prostate cancer.

COLLABORATION

An outcome of the iPROSPECT study is that Ireland has been selected as a contributing site for the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) project. This population-based registry will include patient data and linked blood samples from men with advanced prostate cancer in 8 countries. By analysing the informa-tion and samples, the registry will determine which treatment and care practices deliver the best outcomes for men with advanced prostate cancer to enable them to live the best quality life possible.


BIOBANKINGCRDI continues to advocate for the need for a national policy and framework for biobanking in Ireland and is working with the relevant stakeholders including the Department of Health and Health Research Board to bring this to fruition. For more than ten years, CRDI and the partner institutions have been promoting best practice policies for biobanking in Ireland. Together they have been building on the information and expertise that have been developed throughout the years and their approach for the development of a national policy in biobanking has been to mobilise the community of stakeholders, in a collab-orative and co-ordinated way. With new regulations and standards coming into force in 2018 (EU GDPR, ISO General Requirements for Biobanking, proposed Health Information and Patient Safe-ty Bill) as well as the expectation that Ireland will soon join the Biobanking and BioMolecular Resources Research Infrastructure - European Research Infrastructure Consortium (BBMRI-ER-IC), we believe it is timely to push for a formalised approach to biobanking in Ireland.

In 2017, CRDI brought together a consortium of scientists, clinicians, health economists, patient advocacy groups, legal and ethics experts involved in bio-banking and coordinated a proposal to develop a national biobanking policy that could support and enhance the impact of bench-to-bedside research, in response to the SFI Science Policy Research Pro-gramme 2017 call. This proposal was led by Dr Deirdre Murray of the INFANT Centre UCC and its objectives were to:

• Develop a national strategy to coor-dinate, network and harmonise Irish biobanks

• Examine existing and new ethical, legislation and social issues including incoming data protection regulations impacting biobanking

• Evaluate existing and emerging relevant international biobanking quality standards and develop policy and guidelines to support biobanks attain such standards

• Make recommendations for collec-tions in the national interest, includ-ing the curation and possible use of existing archives

• Explore the international biobank-ing landscape and make recommen-dations to benefit Ireland

• Assess the emergence over the last decade of international biobanking resources and tools and disseminate to clinical researchers, and

• Assess the value of biobanking to translational research and to the Irish economy.

While the proposal was unsuccessful on this occasion, the reviewers described the proposal as outstanding and had the potential to deliver an important frame-work. They recommended including national policy-makers in the consortium and to continue to seek funding.


CRDI’s Translational Research Manager serves as Chair of the Biotechnology Standards Consultative Committee, established by the National Standards Authority of Ireland (NSAI) in 2014 to facilitate national stakeholder involve-ment on standards being developed in the field of biotechnology. A key role of the committee is to act as a nation-al mirror group to the International Standards Office (ISO) Technical Committee (TC) 276 – Biotechnology, ensuring Irish interests are represented and to advise NSAI on the development and approval of standards in this field. There are five Working Groups (WG) in ISO TC/276, of which WG2 relates to biobanks and bioresources.In 2017, members of the Biotechnolo-gy Standards Consultative Committee contributed to the development of the new draft standard entitled ISO Draft International Standard (DIS) 20387 – Biobanking – General Requirements

for Biobanking. Committee member, Emma Snapes (INFANT Centre UCC), who receives travel support from the HRB to represent Ireland at internation-al meetings of ISO TC/276 WG2, was instrumental in the progression of this new standard. A public commenting phase for the draft standard ran from July to September 2017 and a workshop was organised for national stakeholders at St James’s Hospital, Dublin on 14 September. This event was well attend-ed and significant interest was shown in the new standard. Comments were submitted to the NSAI for review by the Biotechnology Standards Consultative Committee and subsequently commu-nicated to ISO as Ireland’s contribution to the public commenting phase for ISO DIS 20387. The new ISO 20387 – Biobanking – General Requirements for Biobanking is now expected to be published by the end of 2018.

Right: Dr. Suzanne Bracken (CRDI) and Linda Hendy (NSAI), Secretary of NSAI Biotech Standards Consultative Committee at Biobanking Standards Workshop


NEW BIOBANKING STANDARD

Clinical Research Development Ireland38 CRDI Annual Report 2017 Clinical Research Development Ireland38 CRDI Annual Report 2017

CRDI / CÚRAM PartnershipDEVELOPING KEY STRUCTURES AND RESOURCES TO SUPPORT MEDICAL DEVICE RESEARCH IN IRELAND

CÚRAM, Ireland’s Centre for Research in Medical Devices, NUI Galway


CRDI is a partner in CÚRAM, Ireland’s Centre for Research in Medical Devices. CRDI leads the project entitled ‘Developing Key Structures and Resources to Support Medical Device Clinical Research in Ireland’, working closely with Professor Matthew Griffin Professor of Transplant Biology, NUI Galway, and Professor Martin O’Donnell Professor of Translational Medicine at NUI Galway & Director of the HRB Clinical Research Facility Galway. The CRDI / CÚRAM partnership provides significant opportunities to advance medical device clinical research through the development and delivery of training and information resources. Project deliverables include in-teractive e-Learning modules and a MedTechTranslate web-portal designed to support the acquisition of skills and knowledge on medical device regulation, map regulatory requirements and path-ways to the medical device life cycle and facilitate cross-sector (academic/clinical/industry) connections to support medical

device innovation. Significantly, the ongoing success of this work is underpinned by constructive engagement with industry, regulators, academic researchers, clinicians and the national clinical research infrastructure. This speaks to the strengths of CRDI in cross-institutional coordination. The cen-tralised regulatory training and informa-tion competencies delivered by this project will form a key resource for CÚRAM and Ireland’s medical device sector.

E-LEARNING

The CRDI / CÚRAM Partnership launched its new European Credit Trans-fer and Accumulation System (ECTS) accredited e-Learning course ‘Funda-mentals in Medical Device Design and Regulation’, with the first intake of 18 postgraduate and postdoctoral researchers from CÚRAM and partner institutions registering to take part in December 2017. The course comprises two modules, Principles of Medical Device Design and

the newly developed EU Regulation of Medical Devices. Course content has been developed to impart important in-dustry, research and regulatory concepts relevant to the entire life cycle of med-ical devices with much of the content produced in collaboration with national and international experts. The course also benefits from the input of national agencies including the Health Products Regulatory Authority and the National Standards Authority of Ireland as well as the involvement of key industry partners including pharmaceutical and medical device companies.

REGULATORY ANALYSIS

In addition to developing centralised competencies on regulatory requirements for medical devices in the EU, the CRDI / CÚRAM Partnership also focuses on analysing how recent changes in EU medical device legislation affect require-ments for medical device development, clinical investigation and the commer-

cialisation of medical device technolo-gies. A 2017 CRDI / CÚRAM Partner-ship publication discusses the impact of these changes on stakeholder responsibil-ities and their potential, going forward, to impact innovation and competitiveness in the MedTech sector1.

MEDTECHTRANSLATE PORTAL – CLINICAL EXPERTISE REGISTRY

MedTechTranslate, the CRDI/CÚRAM Partnership website, is being designed to centralise expertise on medical device research translation. It will host an inter-active portal that maps EU regulatory requirements to key stages of a medical device product’s life cycle whilst signpost-ing device innovators towards relevant practice and expertise information. In addition, MedTechTranslate will serve as a conduit to facilitating increased clinical trials activity by supporting greater link-age between device developers and the clinical community.

The CRDI / CÚRAM Partnership Project is supported by Science Foundation Ireland (SFI) and is co-funded under the European Regional Development Fund under Grant Number 13/RC/2073

1 Behan et al., Medical Writing. 2017 Jun; 26(2):20-24.

CRDI / CÚRAM Partnership


Figure 1.


2

HEALTH SERVICES

ALL-IRELAND

POSTGRADUATE MEDICALTRAINING BODIES


Wellcome-HRB Irish Clinical Academic Training (ICAT) Programme

Following a successful application to the Wellcome Trust, funding was awarded in September 2016 to support an integrated, national training programme for clinician scientists. This unique all-Ireland PhD programme, known as the Irish Clinical Academic Training (ICAT) Programme, is funded primarily by the Wellcome Trust and the HRB, with ongoing collab-oration and additional funding support from its multiple partners including six academic institutions (TCD, UCD, NUI Galway, Queen’s University Belfast, RCSI and UCC), the Health Service Executive National Doctors Training and Planning, the Forum of Irish Postgraduate Medical Training Bodies, the Health and Social Care in Northern Ireland R&D Divi-sion and the Northern Ireland Medical & Dental Training Agency. Clinical Research Development Ireland (CRDI) coordinates the ICAT Programme (See

Figure 1, left). The ICAT Programme will appoint up to 40 Fellows over five consecutive annual intakes, with the first cohort of eight ICAT Fellows commencing in July 2017. It is managed by an Executive Team (Figure 2) who oversee the day-to-day activities of the programme and it is advised by a Steering Committee and an Independent Advisory Board.

ICAT is a collaborative national programme that will train Ireland’s future leaders in academic medicine.

Top row (l-r) Professor Michael Gill (TCD), Dr Patrick Mallon (UCD), Dr Michael Conall Dennedy (NUI Gal-way). Middle row (l-r) Professor Peter Maxwell (Queen’s University), Dr Deirdre Murray (UCC), Professor David Williams (RCSI). Bottom row (l-r) Dr Mark Watson (CRDI), Professor Martina Hennessy (TCD), Dr Karen Misstear (Programme Manager, CRDI).

Figure 2. The ICAT Executive Team


Figure 3. ICAT Training Structure

ICAT Fellows enrol in an introductory first year in which they spend 70% of their time in clinical training (Figure 3). During Year 1, protected academic time enables Fellows to collaborate with a PhD supervisor (http://icatprogramme.org/supervisors/) and develop a PhD project proposal. ICAT supervisors have been selected for their research excel-lence and represent a diverse range of clinical and research specialties. ICAT Fellows can undertake a PhD in any field of interest, from laboratory-based, to

clinical research, medical device de-velopment or big data analysis and we encourage cross-institutional collabora-tions. Other academic activities in Year 1 include designing and undertaking a mini-project and exploring the large multi-institutional curriculum of edu-cational modules offered via the CRDI curriculum portal. Following approval of their PhD proposal, ICAT Fellows register for a PhD in their chosen institution in Year 2. ICAT Fellows do not exit clinical training

during their PhD but maintain a minimal clinical training component (10-20% de-pending on their specialty) thus enabling them to continue to accrue clinical skills and interact with their peers. Collegiality, collaboration and peer support are core values underpinning the ICAT programme, and events for the Fellows include the Annual ICAT Scien-tific Retreat (see Pages 44-45), an annual induction event to introduce new Fellows and regular cohort meetings.

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6

Clinical & Research Skills PhD Complete PhD and CSCST*

Mentoring & career development

Year 1 is a predominantly clinical year (70%), with time protected for academic activities (30%) and development of a PhD proposal. If approved, ICAT Fellows register for a full-time PhD in Year 2 (they do not exit clinical training so maintain a minimal training component). In Year 5 the Fellows return to clinical training positions and complete their PhD thesis and viva voce and apply for postdoctoral fellowships. A key component of the ICAT Programme is continuous career support by an academic mentor and a clinical mentor.

STRUCTURE OF THE ICAT PROGRAMME

*CSCST – Certificate of Satisfactory Completion of Specialist Training


8FELLOWS

50APPLICATIONS

19 SPECIALITIES

Figure 5. Spread of clinical specialties amongst applicants to ICAT in 2017 (first intake)

RECRUITMENT TO THE ICAT PROGRAMME

In keeping with the Wellcome ethos, ICAT aims to attract the brightest clinicians who strive to become academic leaders. ICAT has completed one recruitment cycle for July 2017 (See Figure 5 below) and is in the process

of appointing Fellows for the July 2018 intake. The first intake of ICAT Fellows are embarking upon a wide variety of PhD projects in July 2018, including the inves-tigation of technology-enabled adaptive clinical trial methodologies, a nation-wide cohort study of adverse pregnancy outcomes and the risk of kidney disease

in women and research into biomarkers of psychosis. More information about the ICAT Fellows and their research can be found on our website.

WEBSITE: www.icatprogramme.orgEMAIL: [email protected]: @ICATProgramme

In keeping with the Wellcome ethos, ICAT aims to attract the brightest clinicians who strive to become academic leaders

There were 50 eligible applications to ICAT for its first intake of Fellows in 2017, with 19 clinical specialties represented. Following a rigorous selection and interview process, eight Fellows were appointed, representing six clinical specialties and diverse research interests.


The Wellcome-HRB ICAT Programme hosted its first Annual Scientific Retreat in the coastal town of Malahide near Dublin in November 2017. The theme of the Retreat was ‘Careers in Academic Medicine’ and a number of illustrious speakers shared their experiences with the ICAT Fellows. Guests included Pro-fessor Sir Stephen O’Rahilly, Professor of Clinical Biochemistry and Medicine at the University of Cambridge and Fellow of the Royal Society, who gave an inspirational talk about his career in medicine and his research into metabolic and endocrine disorders, Professor Caro-line Sabin, Professor of Medical Statistics and Epidemiology at University College London, who spoke very entertainingly about how she initiated and manages multicentre studies of HIV-positive individuals across the UK, and Professor Brian Walsh who spoke about his recent journey through the MMI Clinician

Scientist Fellowship Programme and how that has positively impacted on his career in neonatology. The focal point of the Retreat was the presentation of PhD project pro-posals by Year 1 ICAT Fellows, who benefitted from the advice offered by the audience of experienced scientists and clinicians. Other sessions included gender equality in science and medicine, innovation in healthcare and presenta-tions on the research funding landscape in Ireland by representatives from the Health Research Board, the Irish Re-search Council and Enterprise Ireland. A highlight of the Retreat was the interactive ‘fireside chat’, featuring Pro-fessor Luke O’Neill of TCD as host and two clinician scientists: Professor David Williams, Professor of Geriatric and Stroke Medicine at the Royal College of Surgeons in Ireland, and Professor Aoife Lowery, Associate Professor and Consul-

tant Surgeon at NUI Galway. The participants engaged in lively discussions about their careers, and debated the status of healthcare research and careers in academic medicine in Ireland. This session was particularly useful for the trainees of the Academic Track for Internship in Ireland and the Academic Foundation Doctors in Northern Ireland who have an interest in pursuing academic careers in medicine. The Retreat enabled the ICAT com-munity to successfully gather together to advise and support the ICAT Fellows who are embarking upon their careers in academic medicine. It also provided an opportunity for the ICAT Executive Team to reflect on its progress with input from members of the Independent Ad-visory Board who generously offer their time to the ICAT Programme.

The Wellcome-HRB ICAT ProgrammeFirst Annual Scientific Retreat

The theme of the Retreat was ‘Careers in Academic Medicine’ and several illustrious speakers shared their experiences with the ICAT Fellows.


CRDI Short Courses


TECHNIQUES & STRATEGIES 2017

15thYEAR

95ATTENDEES

1,200ATTENDEESSINCE 2003


CRDI coordinates expertise across partner academic institutions and beyond to develop and deliver resources for research training. e-Learning is a focus of CRDI and also of the CRDI/ CÚRAM Partnership. The CRDI online module Case Stud-ies in Drug Discovery & Development was originally developed and delivered as part of the MMI Clinical & Trans-lational Research Scholars Programme (PRTLI5-funded). It is now mainstreamed through CRDI, with delivery across all the partners. In December 2017, 40 applicants from the CRDI partner institu-tions registered for the module and will be delivered in early 2018. The module is accredited 2.5 ECTS in UCD and it is delivered as part of the UCD MSc in Drug Development and Clinical Trials and separately for UCD Conway Institute PhD students.

e-LEARNING

The CRDI Structured Training Curric-ulum Web Portal provides a very flexible resource for assembling graduate edu-cation modules across several training programmes and curricula. This facility is currently used by the Wellcome – HRB ICAT Programme. ICAT Fellows can access the ICAT themed curriculum comprising 192 mod-ules from 6 partner institutions assembled under 12 distinct topics on the platform. The interactive web portal interface provides comprehensive information on each module to registered users.https://www.crdi.ie/resources/crdi-cur-riculum-portal/

ONLINE RESOURCE: CRDI CURRICULUM PORTAL

CRDI Courses & Workshops are part of postgraduate research training in CRDI partner institutions and are available to postdoctoral, technical, academic and clinical staff as continuing professional development in clinical and translational research. The 15th annual CRDI course Tech-niques & Strategies in Molecular Medi-cine took place in Trinity College Dublin on 5 & 6 December 2017. There was good participation with 95 attendees, an increase of 46% compared with the 2016 delivery. Commercial sponsorship totalled €2,000 from five sponsors and discussions are ongoing to explore European Cred-it Transfer and Accumulation System (ECTS) accreditation of the course.

SHORT COURSES


CRDI maintains close links with PhD programme alumni and regularly gathers information on their achievements and career progress.

https://www.crdi.ie/resources/mmi-alumni/

CRDI PhD Programmes Alumni

CTRSP

The Clinical and Translational Research Scholars Programme (CTRSP) was an innovative, structured 4-year PhD programme for science graduates, active from 2011 and 2016. Funded by the Higher Education Authority (HEA) under PRTLI Cycle 5, the aim of the CTRSP was to develop graduates with the knowl-edge and skills to pursue disease-focused research and to bridge gaps between basic scientists, clinical scientists and industry.

With 19 PhDs awarded and one MSc in process, this completes the CTRSP Cohort 1 cycle (20 scholars). In December 2017, 17 of the scholars were confirmed to be in employment or further study and 10 of these were working in industry. CTRSP Scholars worked closely with external industry mentors to develop their transferable skills. To support this, Schol-ars could access ‘SkillsLog’, an online facility developed by CRDI to track and record transferable skills during PhD and Postdoctoral training. https://skillslog.crdi.ie/

CSFP

The Clinician Scientist Fellowship Pro-gramme (CSFP), active between 2007 and 2012, was a structured 3-year PhD programme for medical graduates, with the objective of developing the next gen-eration of clinician scientists who will lead the quest for new therapeutic strategies. 20 PhDs and one MSc were awarded. CSFP Alumni gained further ex-perience in post-PhD training positions internationally, and now hold a wide range of key academic and consultant positions. The programme was funded by the HEA under PRTLI Cycle 4.


Alumni Updates

CSFP ALUMNI UPDATEProf Gerard Curley

CTRSP ALUMNI UPDATEDr Marie Fitzgibbon

In a series of videos published on the CRDI Website, alumni discuss their participation in the CSFP and CTRSP, and in particular the value of the structured training elements as well as the collaborative aspects of the programmes in facilitating PhD research and career development.

INTERNATIONAL INTERESTDr Cyrille Thinnes, Programme Manager for the National Centre of Excellence in Research on Parkin-son’s Disease at the University of Luxembourg, visited CRDI between 18 and 24 October 2017. Cyrille was awarded Erasmus+ career develop-ment funding, sponsored by CRDI. Cyrille met extensively with CRDI staff and toured several translational and clinical research facilities and programmes including the CÚRAM centre in Galway, the HRB Clinical Research Facility in Galway, ICAT centres in CRDI and NUIG, and the Global Brain Health Institute in TCD.

Cyrille’s account of his visit is pub-lished on the CRDI website: https://www.crdi.ie/internation-al-perspective-cyrille-thinnes-eras-mus-visitor-crdi/

It gave me the tools because it gave me the training”Prof Gerard Curley,CSFP Alumni

“It motivated me to pursue a career in industry”Dr Marie Fitzgibbon,CTRSP Alumni

“


New Users

31.49% up on 2016 figures (13,730 v 10,442)

13,730Sessions

34.14% up on 2016 figures(21,449 vs 15,990)

21,449Avg. Session Duration

Similar to previous period(02:14)

02:11

CommsUpdate2017 saw the rebrand from Molecular Medicine Ireland (MMI) to Clinical Research Development Ireland (CRDI) which was then applied across all online and social media platforms. The main challenge was maintaining the visibility of the content from the existing MMI materials and making sure that this crossed over to the new domain name, www.crdi.ie.

13,730

10,442

15,990

21,449

02:14

02:11

WEBSITE STATISTICS

MAILCHIMP TWITTER

24.54% Avg. Open Rate

Industry Avg. 16.4%

5 Updates sent116 new followers

Top tweet: 4,281 impressions

688 followers

LINKEDIN

Top post: 1,591 impressions(ICAT Fellowship call)

618 followers


INCOME 2017 (€)

Course fees -

Partners 534,466

Grants 1,131,578

Reserves Release 322,117

1,988,161INCOME & EXPENDITURE ACCOUNT YEAR ENDED 30 SEPTEMBER 2017Unaudited

FinancialStatement

EXPENDITURE 2017 (€)

Personnel Costs 1,269,647

Conferences & Training 28,451

Rent and Rates 123,793

Office Costs 30,439

Printing and Stationery 15,504

ICT 94,524

Insurance 17,864

CRDI Programme Non Payroll 241,002

Travel & Subsistence 33,834

Professional Fees 21,509

Audit Tax & Accountancy 14,150

Office move rebrand cost 87,758

Depreciation Fixtures and Fittings and Computer Equipment 9,212

Bank Charges 474

1,988,161

Result for the year -


CRDI Team

Paul BarryHead of Finance and Company Secretary

Dr Fionnuala KeaneHead of Clinical Research, Chief Operations Officer,

HRB CRCI

Gemma LeacyProject Manager, CECR

John Mc CourtIT Manager, HRB CRCI

Dr Suzanne BrackenTranslational Research Manager, iPROSPECT

Programme & Biobanking

Fiona CreggQuality and Regulatory

Affairs Manager

Gael ParentEducation and Development

Project Lead

Michèle CunnaneClinical Trial Liaison Manager, HRB CRCI


Dr Karen MisstearWellcome-HRB ICAT Programme Manager

Dr Áine MurphyTranslational Research

Manager, IPCOR Programme

Dr Pat O’ MahonyChief Executive

Ciara PetersAdministration Co-ordinator,

HRB CRCI

Jeremy TownsProgramme Manager

Virginia WallsCommunications and

Admin. Lead

Marta OpiolaAccounts Co-ordinator

Dr Mark WatsonHead of Education and

Development

Cara DooleyIPCOR Researcher

Dr Anne-Marie MillerCRDI/CÚRAM Partner-

ship Project Manager


ABBREVIATIONS & ACRONYMSBBMRI Biological and Biomolecular Resources Research InfrastructureBWG Budget Working GroupCDA Confidential Disclosure AgreementCECR Corporate Enabling of Clinical ResearchCIS Clinical Indemnity SchemeCRC Clinical Research CentreCRF Clinical Research FacilityCSCST Certificate of Satisfactory Completion of Specialist TrainingCSFP Clinician Scientist Fellowship ProgrammeCTN Clinical Trial NetworkCTRSP Clinical & Translational Research Scholars ProgrammeCÚRAM Centre for Research in Medical Devices DCCR Dublin Centre for Clinical ResearchDIS Draft International StandardDMMC Dublin Molecular Medicine CentreEC European CommunityECRIN European Clinical Research Infrastructures NetworkECTS European Credit Transfer and Accumulation SystemEI Enterprise IrelandERIC European Research Infrastructure ConsortiumEU European UnionFP7 Seventh Framework Programme

GCP Good Clinical PracticeHEA Higher Education AuthorityHPRA Health Products Regulatory AuthorityHRB Health Research BoardHRB CRCI Health Research Board Clinical Research Coordination IrelandWT HRB CRF- SJH Wellcome Trust Health Research Board Clinical Research Facility St James’s HospitalHSE Health Service ExecutiveICAT Irish Clinical Academic TrainingICS Irish Cancer SocietyIDA Industrial Development AuthorityIMDA Irish Medical Devices AssociationIMP Investigational Medicinal ProductINFANT Centre Irish Centre for Fetal and Neonatal Translational ResearchIPCOR Irish Prostate Cancer Outcomes ResearchIPHA Irish Pharmaceutical Healthcare AssociationIPPOSI Irish Platform for Patient Organisations, Science and IndustryiPROSPECT Irish Programme for Stratified Prostate Cancer TreatmentIRONMAN International Registry to Improve Outcomes in Men IT Information TechnologyLDC Local Date CentreLWG Legal Working GroupMMI Molecular Medicine Ireland

MRCG Medical Research Charities GroupNCRI National Cancer Registry IrelandNHS National Health ServiceNSAI National Standards Authority of IrelandNUIG National University of Ireland, GalwayPPI WG Public Patient Involvement Working GroupPROMs Patient-reported Outcomes MeasurementsPRTLI Programme for Research for Third Level InstitutionsPWG Pharmacovigilance Working GroupQA Quality AssuranceQC Quality ControlQWG Quality Working GroupRCSI Royal College of Surgeons in IrelandSCA States Claims AgencySFI Science Foundation IrelandSFSWG Study Feasibility Start-up Working GroupSME Small to Medium Sized EnterprisesSOP Standard Operating ProcedureSWG Sponsorship Working GroupTCD Trinity College DublinUCC University College CorkUCD University College DublinUKCRN United Kingdom Clinical Research NetworkWG Working Group


CRDI Staff at the launch of CRDI at Farmleigh House on 2 October 2017

www.crdi.ie

enabling clinical and translational research · 2019-06-11 · fellowship programme launched dublin...

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