irish clinical research infrastructure report (icrin ...crdi.ie/uploads/report on clinical...

Irish Clinical Research Infrastructure Report (ICRIN)

REPORT ON CLINICAL RESEARCH TRAINING

October 2012

Foreword

Professor Michael Gill MD, MRCPsych FTCD

Professor Gill is Professor of Psychiatry and Head of Discipline at Trinity College Dublin and Consultant

Psychiatrist at St James’s Hospital. He is also the Clinical Director of the Wellcome Trust/Health Research

Board Clinical Research Facility at St James Hospital

Professor Dermot Kenny MD, FACC, FRCPI, DABIM

Professor Kenny is Professor of Cardiovascular Biology Royal College of Surgeons in Ireland (RCSI)

He is the Clinical Director of the Clinical Research Centre (RCSI) and is also an Adjunct Professor of the

Biomedical Diagnostics Institute, Dublin City University

In recent years the conduct of clinical research around the globe has changed considerably. In order to

protect participant safety, the regulatory, ethics and research methodology framework has expanded and

become more complex. Together with the growth of evidence-based medicine and rapid advances in basic

sciences, this has created significant demands on clinical researchers. The clinical research team in both

academic and commercial research has expanded to include project managers, scientists, statisticians,

regulatory professionals, study monitors, data managers, and others in addition to research nurses and

clinicians.

To cope with these increasing demands, there is a requirement for standardised and accredited education and

training curricula for staff involved in clinical research conducted in Ireland; to equip them to perform their

roles in a quality based, consistent, and efficient manner that will facilitate the positioning of Ireland as a

location of choice for the conduct of clinical research. This report outlines the education initiatives and

courses currently available in Ireland within clinical research; it charts where the current gaps are and

recommends minimum training requirements specific to the different professions working in clinical

research. The implementation of this curriculum will ensure clinical researchers possess and maintain the

required skill set. The report focuses on the current gaps in training for clinical researchers in Ireland, rather

than covering career tracks for clinical researchers. The HRB committed in its Strategy for 2010-2014 to

fund training and development opportunities that will increase the number and diversity of health

professionals involved in clinical research. As part of this commitment ICRIN was tasked with producing a

clinical research training gap analysis report and continuing education framework for Irish clinical

researchers. ICRIN was chosen for this task based on its experience of providing national IC GCP training;

its interaction with clinical research groups both from industry and academia and following on from its

publication of the ICRIN Clinical Research Roadmap in 2010.

We would like to congratulate the ICRIN team, in particular Siobhan Gaynor and Susan Lennon for

producing this important report which highlights the deficits in the current system, and for the first time, sets

out a clear national clinical research training curriculum, for all stakeholders. Given the ever evolving

nature of clinical research it is incumbent on all clinical research professionals to maintain and update their

skill set. The competency based national framework outlined in this report will provide a standardised,

harmonised and accredited curriculum to do this. A recent European Science Foundation report on medical

research education http://www.esf.org/publications.html , highlights the importance of exposure and access

of medical researchers to European research infrastructures, such as the European Clinical Research

Infrastructures network (ECRIN). At a national level it is critical that ICRIN, with its depth of experience,

and as the Irish partner of ECRIN, plays a key role in the coordination of the development and

implementation of a national clinical research training plan.

Background

The Health Research Board (HRB) was recently presented with a report on the activities of the Irish Clinical

Research Infrastructure Network (ICRIN) funded by a HRB award for the period October 2010 to July 2012.

ICRIN was established by NUIG, RCSI, TCD, UCC, UCD and MMI in 2006 by a MOU signed by the heads

of the institutions and MMI coordinates ICRIN's activities on behalf of the five universities. The objectives

of ICRIN are to:

Engage with the constituent teaching hospitals to develop a national clinical research infrastructure

Harmonise clinical research processes

Connect with the European Clinical Research Network (ECRIN)

Develop education and training programmes for clinical researchers

Support investigators in conducting multi-centre clinical studies

Drive harmonisation of biobanking

With funding from the HRB and other sources, ICRIN - encompassing the expertise of the partner

institutions and the coordinating team in MMI - has made considerable progress towards its objectives. This

report on clinical research training in Ireland encompasses some of the ICRIN clinical research training

activities.

Purpose of report:

To examine the current gaps in training in clinical research in Ireland, based on current regulatory

requirements, feedback from Small to medium enterprise and Pharmaceutical company interaction , Clinical

research centre/Facilities teams and attendees on ICRIN GCP courses. To develop a first draft of a National

Clinical Research Curriculum which should be embedded into and delivered ultimately by the forthcoming

National Clinical research Infrastructure.

Overview of Clinical Research Education & Training currently available in Ireland

http://www.esf.org/publications.html

Academic Programmes

Post graduate Certificate in Clinical Research Nursing (RCSI)

A postgraduate education programme for research nurses was initiated within the Royal College of Surgeons

in Ireland (RCSI) with funding from the HRB via the Dublin Centre for Clinical Research (DCCR) in 2008.

This course includes assessment of clinical research competency and has to-date included nurses from all

over Ireland. This programme is now in its third year. The Nurse Education Programme has developed

expertise in education in clinical research design and methodology, ethics and regulatory affairs, clinical

research practice and management. In addition this course developed a competency assessment schedule

which requires the students to achieve practical clinical learning outcomes and attain defined competency in

key areas related to the role of the research nurse.

MSc in Pharmaceutical Medicine

a)Trinity College Dublin (TCD)

In 2006, Trinity College Dublin introduced a Diploma and a Master’s of Science (MSc) programme in

Pharmaceutical Medicine. These courses are administered by the Department of Pharmacology and

Therapeutics of Trinity College Dublin (TCD), in association with the Centre for Advanced Clinical

Therapeutics, St James’s Hospital, Dublin. They were developed to provide medical and science graduates

with specialist knowledge and skills in the area of clinical pharmacology and pharmaceutical medicine.

b)Hibernia College

Hibernia College, an Irish online college, also offers an MSc in Pharmaceutical Medicine. This MSc was

developed in conjunction with Pfizer and is accredited by the Higher Education and Training Awards

Council (HETAC). The course syllabus consists of ten modules covering topics such as drug discovery,

clinical pharmacology, data management and statistics. This degree is aimed to both medical and non-

medical professionals working in the pharmaceutical industry.

Certificate in Clinical & Translational Research (UCD)

This programme developed by the UCD School of Medical and Medical Science in 2010 and aims to equip

participants with the knowledge, skills and competencies to allow them to complete programmes of clinical

investigation and translational research. Through the development of these core research competencies, the

School hopes to develop a cadre of highly skilled clinical investigators, who will be well positioned to

pursue research programmes.

M.Sc in Clinical Research (NUIG)

The objective of this course developed by the School of Medicine Nurses and Health Sciences’ in NUIG in

2011 is to provide training for the next generation of healthcare workers within the clinical research arena,

providing a platform for increasing efficiencies in the translation of medical discoveries into clinical

practice. Course contributors include senior academics and medical professionals from NUI Galway,

Galway University Hospitals and McMaster University, Canada, who are actively engaged in clinical

research. This programme is closely aligned with the HRB Clinical Research Facility, Galway. It is intended

for individuals employed in the healthcare sector. This course has been developed to meet the needs of

working graduates who wish to up-skill, specialise or change career direction.

The ICRIN team currently contribute modules/lectures on courses at the invitation of the partner institution

as follows:

i. RCSI Research Nurses post graduate certificate

Preparation for GCP inspections/audits and Role of the Clinical Research Associate.

Informed consent in clinical trials.

Introduction to clinical research & Good Clinical Practice.

Biological Samples and Best Practice

ii NUIG MSc in Clinical research

Rules, regulation and ethics in clinical research.

Drug and Device Discovery & Development.

Pharmacovigilance in Development and Post Market Access.

Introduction to clinical research & Good Clinical Practice.

iii UCD Postgraduate certificate in Clinical & Translational Research

Introduction to clinical research & Good Research Practice.

iv. TCD MSC in Pharmaceutical Medicine

The Role of the Clinical research Associate

Fellowships/PhD programmes & Awards are outlined in Appendix 2

Continuing Professional Development Training

ICRIN courses & training

ICRIN hosted the first GCP course in the RCSI Clinical Research Centre and this course has been run 20

times to August 2012 all over Ireland. This course and additional training programmes developed by ICRIN

have been provided to over 600 clinical research personnel throughout Ireland since February 2009.

Date Venue No of attendees

Feb2009 Beaumont/ RCSI CRC 22

April 2009 Mater UCD/CRC 20

July 2009 SVH/UCD CRC 22

Sep 2009 St James’ Hospital 22

Feb 2010 RCSI 27

Mar 2010 Mater UCD/CRC 22

April 2010 NUIG/GUH CRFG 20

May 2010 Beaumont RCSI/CRC 22

July 2010 Trinity/TILDA 28

July 2010 Mater /UCD CRC 20

Sep 2010 SVH/UCD CRC 14

Nov 2010 RCSI 19

April 2011 Mater /UCD CRC 18

June 2011 Beaumont /RCSI CRC 19

Nov 2011 RCSI 25

Nov 2011 NUIG/ GUH CRFG 23

March 2012 St James Hospital 23

April 2012 Crumlin CRC 33

May 2012 St James Hospital 25

July 2012 Mercy/UCC CRF 15

Other Training available

ICORG provide in-house clinical research training for its site and central office staff functions but this is not

currently available publically.

A number of pharmaceutical companies and SME’s currently provide in-house training for their own

clinical research departments and many provide GCP training and study specific training for site staff

in line with their responsibilities as sponsors. There is no commercial GCP training currently

available in Ireland, to our knowledge. However, there is an appetite for nationally accredited

clinical research training that is recognised by the Irish competent authority and industry alike.

MMI Education & Training programmes and courses

The MMI cross-institutional Courses & Workshops Programme, beginning in 2003 as a DMMC

activity funded in PRTLI Cycle 3, has built on the research and teaching strengths of the partner

institutions and the clinical expertise in the affiliated teaching hospitals.

MMI Courses (lecture-based and practical courses of 3-35 contact hours) are designed specifically

for a cross-institutional audience, are delivered by faculty from multiple institutions (including

international keynote lecturers and industry representatives), and are coordinated via a dedicated

administrative infrastructure, with a strong online presence and continual course development

assisted by participant feedback. Courses have been specifically designed and delivered to make

accessible various technologies, including proteomics and genomics; and to support translational

research in various disease areas.

Identification of Gaps in Clinical Research training

As described above many aspects of education in clinical research are either available or planned through

universities and other institutions. It is recognised by the Lifescience industry in Ireland, that university

postgraduate programmes in collaboration with industry are necessary, particularly in the areas of design,

management and conduct of clinical trials. In addition from the lifescience industries point of view it is

necessary to increase involvement by clinicians in medical device innovation. In particular support should

also be given to the development of professional and specialist skills in specific sectors such as regulatory

affairs and clinical trials management.

As technological convergence in the medical devices industry progresses, introductory programmes are

required, which bring together mechanical, electronic and biosciences technologies. Indeed IPHA have

suggested that accredited training in Good Clinical Practice should be integrated into medical and nursing

education at undergraduate as well as postgraduate levels.

The ICRIN GCP course for investigational medicinal products (IMP) was developed in response to a gap

identified in training in GCP and is now available as a publically accessible GCP course, delivered

nationally. It has evolved in response to attendee feedback since 2009, and the current one day course now

covers the following:

Clinical research terminology and history

Drug and medical device development

Rules and regulations

Consent and ethics committees responsibilities

Investigator responsibilities

Essential Documentation

Paediatric clinical research section included as relevant

Feedback from over 600 attendees on ICRIN clinical research training courses and lectures since 2009 and

also from analysis of information from the pilot “research readiness” exercise is detailed below.

The following areas have been identified from feedback as key areas of training required in order to sustain,

develop and continue to support the research infrastructure in Ireland.

1. Clinical research training Courses required:

A. Irish Clinical Research processes and landscape

Ethical submissions/procedures/applications

Regulatory submissions

Clinical trials insurance/indemnity issues

Ethical considerations in clinical research

B. Clinical Research Practice and Project Management

Study set up

Patient recruitment

Budgeting

Biological samples

Maintenance of site files

Collaborate Agreement Templates

Trial Costing Guidance and templates

C. Quality Management: Quality Assurance and Quality Control

CRF completion/data entry considerations

Quality systems

IMB audit

Trial Document management and Archiving

Trial Reporting and Communication

Agreements and Contracts

Master Service Agreements and Work Orders

Protocol, Report, Trial management forms and templates

Quality Management

Preparation for GCP Inspections

Safety Monitoring and Pharmacovigilance

D. Study Design/Methodology/Statistics

Core Statistical Analysis

Statistical Methodology and computer packages

Clinical Trial Design

Effect size and power analysis

Data management, Validation and Handling.

Genomics:- analysing association, GWAS, Next Gen sequence data

E. Study and therapy specific training

Legislation in relation to cell therapy/advanced medicinal products, genetically modified organisms

Rare diseases and orphan drug legislation

Paediatric clinical research

Medical device legislation and clinical investigations

Nutrition clinical research

F. Miscellaneous

Overview of international trials + co-operative groups

How to apply for funding for CT’s

Biobanking – best practice

Refresher courses (e.g. GCP)

Health Technology Assessment

Other considerations of relevance

ICRIN undertook a pilot research readiness exercise as part of its HRB funded deliverables in 2010/2011.

The scope of the research readiness pilot programme was to identify, at a granular level, the national and

local processes that need to be prioritised for completion to serve as the core of a supporting framework for

researchers. A key finding from the pilot research readiness exercise conducted in three centres to date, is

the immediate need for appropriate training courses to be provided for clinical research personnel working

in research groups and clinical research centres/facilities. In particular the need for additional capacity and

expertise in project management of clinical research needs to be addressed.

In addition, a fundamental need identified from feedback on ICRIN lectures, courses and interactions with

many stakeholders to date, is the requirement for more practically orientated training courses; more of a

focus on the “how to” as opposed to “why”. Clinical researchers need to be more proficient at

implementation of the regulations and standards within the context of their own particular research focus;

they need to be knowledgeable about forthcoming changes to regulations as well as deciphering the

implications for their working practices and procedures.

Good Clinical Practice is an international quality standard for the conduct of clinical research involving

human participants. GCP Guidelines state that “Each individual involved in conducting a trial should be

qualified by education, training, and experience to perform his or her respective task(s).” To comply with

this requirement many organisations recruit clinical research professionals with a minimum number of years

experience and require them to attend regular training sessions. For inspection and auditing purposes, CVs,

training certificates (certificates of attendance) and training materials are maintained. These are evidence of

employment history, previous experiences and what has been covered on the courses they attended.

However, they do not provide evidence of competence or learning transfer i.e. that the intended learning

outcomes of the course have been achieved or that the individual has understood the course and can apply

what they have learned to their own job. Therefore, the design and delivery of learning interventions varies

greatly in quality and evidence of learning and competence is often ineffectively measured or not measured

at all.

Proposed Competency & Training Framework for Clinical Research It is the responsibility of organisations managing and sponsoring clinical research studies to ensure that

people working within clinical research have the right skills, knowledge and behaviours to support the

ultimate goal of protecting the rights and wellbeing of the clinical trial subjects and the integrity of the data.

It is also important to provide reassurance for clinical trial patients, the public and potential users of clinical

research providers such as CRC/F’s that research is in the hands of skilled people.

The challenge of training in clinical research needs to be addressed at many levels.

Undergraduate and Preparatory – incorporation of an introduction to clinical research into the course

content for medical students, nursing students, pharmacy students and other undergraduate healthcare

professions, as well as enabling access to postgraduate clinical research courses and clinical placement for

those planning to enter the clinical research arena. This is outside of the scope of this report.

Study Specific Training – Different studies require different skill sets, and under the legislation, it is the

sponsor’s responsibility to provide study specific training to all investigators. As the national infrastructure

for clinical research evolves it is envisaged that it will develop study specific education and training

packages for investigator led clinical research, and provide a medium for networked delivery and

administration of this research. .

Orientation and Induction programmes – These programmes are required to ensure a harmonised and

organised approach for both those new to clinical research and for those in clinical research where new

projects are being developed. In addition, some element of mentoring should be incorporated into these

programmes. It would be desirable that the clinical research training matrix outlined below be adopted by

all CRC/F’s and other research groups in order to ensure adherence to quality national standards. In addition

each CRC/F and other clinical research groups should develop an orientation and induction programme to

include local issues such as site specific safety issues, local standards and procedures and IT and security

aspects. An orientation folder has been prepared and implemented by the RCSI CRF and the experience

gained to date from this could be rolled out nationally by the proposed National Clinical Research

Infrastructure.

Clinical Research National Curriculum- Outlined in more detail below

Continuing Professional Development –Currently, there are no readily available guidelines, procedures,

and courses to ensure the availability of mandatory compliance and safety training. This needs to be

addressed by working with the relevant professional bodies (INO, IMO, RCSI, RCPI, ICGP etc) as well as

the competent authority (IMB) and should form one of the work streams of the Group tasked with education

and training within the context of a national infrastructure for clinical research.

National Clinical Research Curriculum

The expertise, training materials, experience and feedback derived from the ICRIN GCP courses and other

modules developed by ICRIN to date as part of its HRB deliverables could be used to develop a training

programme as part of the activities of the proposed National Clinical Research Infrastructure.


Research governance & Ethics: Irish landscape

Drug & medical device development process

Ethical considerations in clinical research

Clinical Trials Insurance and Indemnity


Clinical Trials Project Management

Patient recruitment and Informed Consent

Essential Documentation in Clinical research

Biological Samples and best practice

Trial Costing and Budgeting (TBD)


Preparation for Inspections & Audits

Clinical trial Protocol Development

Safety Monitoring & Pharmacovigilance

Quality management Systems (TBD)


Statistics for non-statisticians

Data Management (TBD)

Clinical Trial design (TBD)


Paediatric Clinical research

Medical device clinical investigations

Rare diseases and orphan drug legislation (TBD)

Advanced Medicinal Products, genetically modified organisms and combination

products (TBD)

Nutrition Clinical Research (TBD)

F. Good Clinical Practice (GCP)

Clinical research terminology and history (Day 1)

Drug and medical device development (Day 1)

Rules and regulations (Day 1)

Consent and ethics committees responsibilities (Day 1)

Investigator responsibilities (Day 1)

Sponsor Responsibilities (Day 2)

Agreements and Contracts (Day 2) (TBD)

Trial Reporting and Communications (Day 2) (TBD)

Appendix 1 to this document lists the relevant module descriptors of courses developed and delivered by

ICRIN to date, categorised under the headings above. ‘TBD’ indicates those modules that are to be

developed and this could be undertaken by ICRIN in advance of the formation of the education core of the

proposed National Clinical Research Infrastructure.

A training matrix, based on the programme above, could form the basis for provision of training for Irish

clinical research personnel. This should evolve and be adapted as the national clinical research infrastructure

develops. As new clinical research personnel are employed, it should be a requirement that they complete

the requisite modules for their roles within a year of taking over the role. It is also desirable that GCP

training is received in the first 3 months of commencing the role. Frequency of ongoing training should be

determined by the Education & Training group of the National Clinical Research Infrastructure and should

be assessed continually.

All training programmes and materials developed as part of the infrastructure should be independently

quality assured, certified and accredited in order to ensure consistency, standardization and assure

compliance with best international practice. All clinical research personnel should ideally, have electronic

training and development files that will be made available to Clinical research sponsors upon request, as

required by the European Clinical Trials Directive. This will ensure that there is minimal duplication in

training provision.

Proposed National Clinical Research Training matrix

√-Mandatory *-As required, determined by sponsor

Roles

Modules A B C D E F

CRC Director/PI √ √ √ * √

Quality Manager √ √ √ √ * √

Trial/Project Manager √ √ √ √ * √

Research Nurse √ √ √ √ * √

Trial Monitor √ √ √ √ * √

Data Manager √ √ √ * √

Lab Manager √ √ * √

Statistician √ √ * √

Administrator √ √ * √

In addition to the modules listed above, the National Infrastructure should provide additional courses and

modules as requested from ICRIN GCP training attendees to date.

Next Steps:

1. Consultation with wider clinical research stakeholder community including, funders, disease

networks and other clinical researchers.

2. Commitment by CRC/F’s to adoption of training matrix outlined above as a minimum national

standard.

3. Development of outstanding modules elucidated in national Clinical research curriculum

4. Ensure the deficits outlined and competency framework suggested is aligned with the eructation and

training section of a proposal for National Clinical Research Infrastructure.

5. Transition all ICRIN education and training activities into the National Clinical Research

Infrastructure when established.

Conclusions:

This report has highlighted the need for competency based training to be provided for the full breadth of

clinical research professionals working in Ireland. This training should be harmonised, standardised and

accredited to ensure that the clinical research workforce in Ireland is trained in a consistent and

comprehensive manner, have sufficient knowledge of the required ethical and regulatory framework as well

as the science underpinning clinical trial design, in line with their respective roles in clinical research. A

National Clinical Research Curriculum should be developed within the proposed National Clinical Research

Infrastructure and consideration should be given to providing some of the core modules online. It is

essential that all clinical research groups adopt the minimum training requirements matrix to ensure

cohesiveness and standardisation in training programmes. This should assure regulators, funders, industry

and the health service that clinical research conducted by clinical research personnel who adhere to this

framework are competent, compliant with relevant legislation and sufficiently trained to carry out their

respective roles. In addition, the education framework should go some way towards establishing

acknowledged career paths for research nurses, principal investigators, project/programme managers, data

mangers, biostatistician etc; in clinical research. It will also contribute to making Ireland an attractive place

in which to do clinical research.

Appendix 1 Module Descriptors for courses developed and delivered by ICRIN to date to form part of the

National Clinical Research Curriculum


Contributors Siobhan Gaynor, Fionnuala Gibbons, Susan Lennon ICRIN

Indicative

Learning

Outcomes

On completion, students should have an understanding of the following areas:

Irish Clinical Research Landscape

Bodies charged in Ireland with review of clinical research

Categories of clinical research, drug, device and others

Ethical review process for clinical research

Students should be able to apply these concepts intelligently in practical terms,

such as the categorisation of clinical research, review and application

procedures for subtypes

Learning

Activities

Advance reading 4 hours

Lectures 2 hours

Interactive learning 1 hours

Total 7 hours

Assessment

Strategies MCQ

Delivery &

Schedule Lecture and learning over 1.0 day

Module Title Drug and Medical device development Process


Indicative

Learning

Outcomes


Drug and device development Process

Market Access

Ongoing requirements once on the market


such as the categorisation of clinical research, review and application

procedures for subtypes

Learning

Activities


Lectures 2 hours


Total 9 hours

Assessment

Strategies MCQ

Delivery &

Schedule Lecture and learning over 0.5 days

Module Title Ethical Considerations in Clinical Research

Contributors

Siobhan Gaynor, ICRIN

Indicative

Learning

Outcomes


History and evolution of ethical aspects of clinical research

Declaration of Helsinki

Informed Consent

Informed consent in vulnerable populations

They should be able to apply knowledge in developing consent documentation.

Learning

Activities


Lectures 3 hours


Total 7 hours

Assessment

Strategies MCQ

Delivery &


Module Title Clinical Trial Insurance & Indemnity

Contributors

Susan Lennon, Siobhan Gaynor & Fionnuala Gibbons ICRIN

Indicative

Learning

Outcomes


Difference between insurance and indemnity

Patient Compensation

Clinical Indemnity Scheme

Product Liability

Students should be able to understand the requirement for appropriate insurance

coverage depending on the nature of the intervention in clinical research, the role

of the clinical indemnity scheme and additional insurance requirements

Learning

Activities


Lectures 2 hours

Interactive learning 2hours

Total 7 hours

Assessment

Strategies MCQ

Delivery &



Module Title Clinical Trials Project Management

Contributors


Indicative Learning

Outcomes

On completion, students should have an understanding of the

following areas:

Trial Planning and set-up

Clinical Trial team

Key trial Documents

Key Milestones

Patient Recruitment Challenge

Students should have a good understanding of overall trial set-up,

principles of clinical trial project management

Learning Activities


Lectures 2 hours


Total 7 hours

Assessment Strategies MCQ

Delivery & Schedule Lecture and learning over 1.0 day

Module Title Patient recruitment and Informed Consent

Contributors Siobhan Gaynor, Fionnuala Gibbons and Susan Lennon ICRIN

Indicative Learning Outcomes


1. Patient Recruitment Challenges 2. Patient Recruitment Potential Solutions 3. Informed Consent Process 4. Common deficiencies in Consent Process

Learning Activities


Lectures 3 hours


Total 7 hours



Module Title Biological Samples and Best practice

Contributors Suzanne Bracken and Siobhan Gaynor ICRIN

Indicative Learning

Outcomes


following areas:

• What is a Biobank and why we need them

• Biobanking Legislation

• Ethics

• Guidelines

• Practical Biobanking

• Biobanking Initiatives

Students should have a broad overview of the considerations of

biobanking and practical aspects of management of biorepositries.

Learning Activities


Lectures 2 hours


Total 7 hours



Module Title Essential Documentation in Clinical research

Contributors


Indicative Learning

Outcomes


following areas:

Trial Master File

Investigator Site File

Templates

Standard Operating Procedures

Learning Activities


Lectures 2 hours


Total 7 hours




Module Title Preparation for GCP Inspections/audits

Contributors

Siobhan Gaynor, Fionnuala Gibbons, Susan Lennon ICRIN

Indicative

Learning

Outcomes


Difference between audit and inspection

Legal basis for GCP inspections

Process of inspection

Preparation for Inspection

Common GCP inspection findings


and ensure they have understanding of issues of relevance

Learning

Activities


Lectures 2 hours


Total 9 hours

Assessment

Strategies MCQ

Delivery &


Module Title Clinical Trial Protocol development


Indicative

Learning

Outcomes


Protocol Content checklist

Sample Protocol Templates

Steps in Protocol Development

Team involved in protocol development


and ensure they have understanding of issues of relevance

Learning

Activities


Lectures 1 hours


Total 7 hours

Assessment

Strategies MCQ

Delivery &


Module Title Safety Monitoring & Pharmacovigilance

Contributors Susan Lennon, ICRIN

Indicative

Learning

Outcomes


Safety lifecycle in drug development

Collection of safety data

Analysis of safety data

Reporting requirements & timelines

Students should be able to understand the requirement for safety monitoring in

clinical research and the responsibilities of the investigational team with

timelines and data required

Learning

Activities


Lectures 2 hours


Total 7 hours

Assessment

Strategies MCQ

Delivery &



Module Title Statistics for Non-statisticians

Contributors Siobhan Gaynor, ICRIN

Indicative

Learning

Outcomes


Statistics in Clinical research

Data Analysis

Statistical section of protocol

Outcome measures

Probability

Students should be able to understand the basic statistical concepts for clinical

research and interact competently with statistician in developing clinical

research protocol

Learning

Activities


Lectures 3 hours


Total 7 hours

Assessment

Strategies MCQ

Delivery &



Module Title Paediatric Clinical Research

Contributors Susan Lennon ICRIN

Indicative

Learning

Outcomes


Need for pediatric clinical research

Paediatric medicines legislation

Consent/assent in children

Paediatric research specific considerations

Product Liability

Students should have a broad overview of the specific issues for paediatric

clinical research, legislation applicable and practical considerations involved in

doing research in the pediatrics setting

Learning

Activities


Lectures 2 hours


Total 7 hours

Assessment

Strategies MCQ

Delivery &


Module Title Medical Device Clinical Investigations

Contributors Fionnuala Gibbons ICRIN

Indicative

Learning

Outcomes


• ISO 14155: 2011

• What is a Clinical Investigation

• Clinical Investigation Planning

• Reimbursement Considerations

• Market Considerations

• Pre-Clinical requirements

• Types of Clinical Investigations

• Why are Clinical Investigations Performed

Learning

Activities


Lectures 3 hours


Total 7 hours

Assessment

Strategies MCQ

Delivery &

Schedule

Lecture and learning over 1.0 day

Module Title Sponsor responsibilities in Clinical research

Contributors Siobhan Gaynor ICRIN

Indicative

Learning

Outcomes


• Definition of sponsor

• GCP responsibilities of sponsor

• Contracts and Insurance requirements

• Documentation

Learning

Activities


Lectures 3 hours


Total 7 hours

Assessment

Strategies MCQ

Delivery &


Appendix 2

HRB/HSE Academic Fellowship Programme: The NSAFP is targeted at medical trainees at the early stages of, or about to commence,

higher specialist training who wish ultimately to specialise in research or make a career in

academic medicine. Eligible applicants must either be currently on a SpR/SR training

programme or applying for entry at the immediate subsequent uptake. Only candidates

that are successful in securing a place on a specialist training programme can be

considered for the NSAFP. The fellowships will be funded jointly by the HSE and the

HRB and up to four fellowships have been offered in the first call.

HRB Research Training Programme Fellowships for Healthcare Professionals

HRB research training fellowships provide three years full-time funding to health and

social care professionals who wish to undertake training in clinical research in a

recognised research institution on the island of Ireland, leading to a PhD (or in

exceptional cases and where suitably justified a Masters degree by research). The

fellowship scheme is aimed at individuals of outstanding potential working within the

HSE or within a voluntary/not-for-profit organisation in Ireland involved in health and

social care provision. While it is primarily targeted at those engaged in clinical practice,

applicants from higher education institutes may apply where they can demonstrate

appropriate practice-based experience and where the focus of their application is relevant

to the objectives of this scheme. Health care professionals working in private practice but

providing services to clients under the GMS scheme will also be considered.

Bioinnovate Ireland

The Fellowship programme is a specialist medical device innovation training programme,

modelled on the prestigious Stanford BioDesign programme. During the programme the

Fellowship teams focus on three phases:

The programme begins with a five-week intensive boot camp on the process of

innovation. The following eight weeks are spent in clinical immersion whereby the

Fellowship teams are immersed in diverse clinical environments across Ireland. This

process involves observing patients and healthcare professionals in a range of clinical

settings including: specialist diagnostic clinics, surgical and interventional procedures,

post-operative care and rehabilitation.

Invent Solutions by Refining the Needs

The Fellowship team focuses on processing the unmet clinical needs, uncovered during

the previous "Identify" phase and progressing them through the Innovation process,

ultimately brain-storming to develop a range of potential solutions.

Implement the Commercialisation of these Solutions

Once the clinical needs are evaluated and their potential solutions have progressed

through the concept phase, the teams then need to consider their Implementation strategy

which involves prototyping, regulatory affairs and reimbursement strategies.

MMI Clinician Scientist fellowship Programme

In September 2007, the Higher Education Authority awarded funding under the

Programme for Research in Third Level Institutions (Cycle 4) for a Clinician Scientist

Fellowship Programme (CSFP) in translational medical research to be coordinated by

Molecular Medicine Ireland. The objective of the CSFP is to train the next generation of

clinician scientists (academic medical leaders) with the unique and specialised knowledge

essential to fulfil Ireland's research needs in translation medicine.

This training programme transcends institutional boundaries to give Fellows access to the

top biomedical researchers in the country and to state-of-the-art basic and clinical

research facilities. The aim is to educate biomedical investigators who, motivated by the

intellectual challenge of understanding disease at the molecular level, will lead the quest

for new therapeutic strategies. The programme is to provide a systematic way to train this

essential group of clinician researchers through a structured PhD programme for medical

graduates of three years in length, with the majority beginning their Fellowships in July

2008.

MMI Clinical & Translational Scholars research programme

In July 2010, the successful Molecular Medicine Ireland bid, led by NUI Galway with

partners Trinity College Dublin, University College Cork and University College Dublin,

secured funding for a collaborative structured PhD ‘MMI Clinical & Translational

Research Scholars Programme' under Cycle 5 of PRTLI.

The MMI Clinical & Translational Research Scholars Programme (CTRSP) is a unique

cross-institutional programme which will develop graduates with knowledge and skills to

pursue disease-focused research and bridge gaps between basic scientists, clinical

scientists and industry. This programme is developed with and includes significant

involvement of industry and of the Irish Medicines Board. Industry partners include

Amgen, Creganna-Tactx Medical, Merrion Pharmaceuticals, Medtronic, Opsona, and

Pfizer.

HRB Clinician Scientist Awards:

The HRB is aiming to establish a critical mass of research leaders in the Irish health

service who will act as role models and mentors; and to further develop and support

outstanding individuals as research leaders within the health system.

The HRB is targeting senior health practitioners with an outstanding research track record

who wish to (1) further develop an internationally competitive programme of research of

direct relevance to their clinical work, (2) promote the implementation of evidence into

practice and policy. Applicants are encouraged to establish multi-disciplinary teams,

including relevant participants from other institutions where appropriate. Furthermore, the

research proposals should have a team-based collaborative approach with the applicant as

lead and should be embedded within the clinical environment in which the applicant

operates, demonstrated by the support of the applicant’s clinical director or equivalent.