Irish Clinical Research Infrastructure Report (ICRIN) REPORT ON CLINICAL RESEARCH TRAINING

Transcription

1 Irish Clinical Research Infrastructure Report (ICRIN) REPORT ON CLINICAL RESEARCH TRAINING October 2012

2 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

3 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 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 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 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 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

4 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 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 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 nonmedical 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:

5 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 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

6 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.

7 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

8 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;

9 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.

10 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. A. Irish Clinical Research processes and landscape Research governance & Ethics: Irish landscape Drug & medical device development process Ethical considerations in clinical research Clinical Trials Insurance and Indemnity B. Clinical Research Practice and Project Management Clinical Trials Project Management Patient recruitment and Informed Consent Essential Documentation in Clinical research Biological Samples and best practice Trial Costing and Budgeting (TBD) C. Quality Management: Quality Assurance and Quality Control Preparation for Inspections & Audits Clinical trial Protocol Development Safety Monitoring & Pharmacovigilance Quality management Systems (TBD) D. Study Design/Methodology/Statistics Statistics for non-statisticians Data Management (TBD) Clinical Trial design (TBD) E. Study and therapy specific training 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)

11 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 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 * -Mandatory *-As required, determined by sponsor

12 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.

13 Module Title Ethical Considerations in Clinical Research Appendix 1 Module Descriptors for courses developed and delivered by ICRIN to date to form part of the National Clinical Research Curriculum A. Irish Clinical Research processes and landscape Indicative Activities Assessment Strategies Delivery & Schedule Module Title Indicative Activities Assessment Strategies Delivery & Schedule Siobhan Gaynor, Fionnuala Gibbons, Susan Lennon ICRIN 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 4 hours 1 hours Drug and Medical device development Process Siobhan Gaynor, Fionnuala Gibbons, Susan Lennon ICRIN On completion, students should have an understanding of the following areas: Drug and device development Process Market Access Ongoing requirements once on the market 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 6 hours 1 hours 9 hours Lecture and learning over 0.5 days

14 Indicative Activities Assessment Strategies Delivery & Schedule Module Title Siobhan Gaynor, ICRIN On completion, students should have an understanding of the following areas: 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. 1 hours Clinical Trial Insurance & Indemnity Susan Lennon, Siobhan Gaynor & Fionnuala Gibbons ICRIN On completion, students should have an understanding of the following areas: Indicative Activities Assessment Strategies Delivery & Schedule 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 2hours

15 B. Clinical Research Practice and Project Management Clinical Trials Project Management Module Title Siobhan Gaynor, ICRIN On completion, students should have an understanding of the following areas: Indicative Activities Assessment Strategies Delivery & Schedule Module Title 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 4 hours 1 hours Patient recruitment and Informed Consent Siobhan Gaynor, Fionnuala Gibbons and Susan Lennon ICRIN On completion, students should have an understanding of the following areas: Indicative Activities Assessment Strategies 1. Patient Recruitment Challenges 2. Patient Recruitment Potential Solutions 3. Informed Consent Process 4. Common deficiencies in Consent Process Delivery & Schedule

16 Module Title Biological Samples and Best practice Suzanne Bracken and Siobhan Gaynor ICRIN On completion, students should have an understanding of the following areas: What is a Biobank and why we need them Biobanking Legislation Indicative Ethics Guidelines Practical Biobanking Biobanking Initiatives Activities Assessment Strategies Module Title Delivery & Schedule Students should have a broad overview of the considerations of biobanking and practical aspects of management of biorepositries. 2hours Essential Documentation in Clinical research Siobhan Lecture and Gaynor, learning ICRIN over 1.0 day On completion, students should have an understanding of the following areas: Indicative Trial Master File Investigator Site File Templates Standard Operating Procedures Activities Assessment Strategies 2hours Delivery & Schedule

17 C. Quality Management: Quality Assurance and Quality Control Module Title Preparation for GCP Inspections/audits Siobhan Gaynor, Fionnuala Gibbons, Susan Lennon ICRIN On completion, students should have an understanding of the following areas: Indicative Activities Assessment Strategies Delivery & Schedule Module Title Difference between audit and inspection Legal basis for GCP inspections Process of inspection Preparation for Inspection Common GCP inspection findings Students should be able to apply these concepts intelligently in practical terms, and ensure they have understanding of issues of relevance 4 hours 1 hours 9 hours Clinical Trial Protocol development Siobhan Gaynor, Fionnuala Gibbons, Susan Lennon ICRIN On completion, students should have an understanding of the following areas: Indicative Activities Assessment Strategies Delivery & Schedule Protocol Content checklist Sample Protocol Templates Steps in Protocol Development Team involved in protocol development Students should be able to apply these concepts intelligently in practical terms, and ensure they have understanding of issues of relevance 4 hours 1 hours

18 Module Title Safety Monitoring & Pharmacovigilance Susan Lennon, ICRIN On completion, students should have an understanding of the following areas: Indicative Activities Assessment Strategies Delivery & Schedule 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 2hours D. Study Design/Methodology/Statistics Module Title Indicative Activities Assessment Strategies Delivery & Schedule Statistics for Non-statisticians Siobhan Gaynor, ICRIN On completion, students should have an understanding of the following areas: 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 1 hours

19 E. Study and therapy specific training Module Title Indicative Activities Assessment Strategies Delivery & Schedule Module Title Paediatric Clinical Research Susan Lennon ICRIN On completion, students should have an understanding of the following areas: 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 2hours Medical Device Clinical Investigations Fionnuala Gibbons ICRIN On completion, students should have an understanding of the following areas: ISO 14155: 2011 What is a Clinical Investigation Indicative Clinical Investigation Planning Reimbursement Considerations Market Considerations Pre-Clinical requirements Types of Clinical Investigations Why are Clinical Investigations Performed Activities 2hours

20 Assessment Strategies Delivery & Schedule

21 Module Title Indicative Sponsor responsibilities in Clinical research Siobhan Gaynor ICRIN On completion, students should have an understanding of the following areas: Definition of sponsor GCP responsibilities of sponsor Contracts and Insurance requirements Documentation Activities Assessment Strategies Delivery & Schedule 2hours

22 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.

23 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 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.