RESEARCH
PROFESSIONAL
PORTFOLIO
INCORPORATING
A RESEARCH SPECIFIC
INDUCTION PROGRAMME
Index
Section Page No
1. Introduction to the Research and Innovation Division 3
2. Local Induction Checklist 13
3. Research Specific Competency Framework 27
4. Reflective Tools 75
5. Six Month review 84
6. Ongoing Competency Assessment 85
K:\induction\Research specific induction pack - Version 03.07.2010.doc Page 23 of 87
SECTION 1 – INTRODUCTION TO R&I DIVISION
Firstly – Congratulations on your success and welcome to Central Manchester and Manchester Children’s University Hospitals NHS Trust. We hope that you are looking forward to working with us.
Primarily, the Trust comprises of:
Manchester Royal Infirmary
Manchester Royal Eye Hospital
St Mary’s Hospital
The Royal Manchester Children’s Hospitals.
We are committed to encouraging and supporting newly –registered practitioners, those returning to practice and those entering a new clinical environment, to develop fully in their professional careers.
We have developed this research professional portfolio within the R&I Division to assist staff new to research roles to make the smooth transition into the exciting world of research and innovation. Our approach is to support a six-month induction period in conjunction with a robust competence assessment and development programme.
This portfolio has been designed to support, assist and encourage you to develop your knowledge and skills in all areas of research practice. It is based on a number of existing frameworks within CMFT and will form part of your learning and development record. It should be available at work so that you can add to it as appropriate and use to support your KSF reviews.
It is intended to be used as a tool to aid your learning and development, any learning identified will obviously depend on any previous experience and knowledge, the tools are meant as a guide and can be used flexibly to meet your personal requirements. It should therefore be tailored to ensure you have the necessary knowledge and skills to do your job. It is, therefore, important that you complete the enclosed documentation and activities, and achieve your personal and professional development objectives with
Research Buddies
During your induction period we will endeavour to assign you to an experienced research practitioner, who will be known as your research buddy. The role of the research buddy is guide you through the portfolio, facilitating your learning and development, and long with your line manager, ensuring you develop the required research competence.
Acknowledgements
Many thanks to Greater Manchester, Lancashire and South Cumbria MCRN for sharing their competency document and allowing its adaptation
Improving healthcare through world class research
CMFT Vision
To become the leading integrated health, teaching, research and innovation campus in the NHS and to position itself on an international basis alongside the major biomedical research centres, as part of the thriving city region of Manchester
We aim to position the Trust as a prestigious internationally renowned centre for research and innovation. Clinical research is the cornerstone of first-class healthcare for the people of Greater Manchester, and the Trust has a research portfolio to be proud of. With excellent facilities and internationally renowned researchers, we are gaining a global reputation for pioneering research in, among other areas, experimental therapeutics, genetic and developmental medicine, and tissue injury and repair. In partnership with The University of Manchester and other collaborators we are rapidly making Manchester the centre of cutting-edge work to improve the healthcare of all.
The Research and Innovation Division
The Research and Innovation Division manages and co-ordinates all of the infrastructure and resources that are used to support research in the Trust.
Key Contacts
R&I Operational Director (acting) Kathy Evans
R&I Director of Innovation and Technology Keith Chantler
R&I Clinical Director Colin Sibley.
R&I Lead Nurse Gail Holmes
Head of Research Office Lynne Webster
Divisional Research manager (Medicine) Manju Luckson
Divisional Research manager (Surgery/Eye/Dental) Iain McLean
Divisional Research manager (St Mary’s) Sarah Leo
Divisional Research manager (Children’s/CSS) Alison Robinson
Roles and responsibilities
Head of Research and Innovation Division
The Head of Division has overall leadership responsibility for the performance of the Research and Innovation Division and for setting the Trust's strategic research direction, ensuring that the Trust achieves its ambition to become a world-leading integrated health, teaching, research and innovation campus.
Divisional Directorfor Research and Innovation Division
The Divisional Director is responsible for the delivery of high quality and safe research services within the Trust through the operational management of the Research and Innovation Division, overseeing the performance of key departments such as the Research Office, Biomedical Research Centre and Medical Illustration.
Director of Academic Affairs and Innovation
The Director of Academic Affairs and Innovation provides the leadership for the Trust’s innovation activities, and is responsible for the protection and commercialisation of its intellectual assets. He manages the Trust’s external partnerships with industry, universities and strategic partnerships with the NWDA and NIHR.
Director of Manchester BiomedicalResearch Centre
The Director ofthe Biomedical Research Centre has leadership responsibility for the performance of the BRCas we put in place the infrastructure toenable us to translate fundamental biomedical research into clinical research that benefits patients and adopt new insights in technologies, techniques and treatments for improving health.
Lead Nurse
The role of the Lead Nurse for Research and Innovation is to provide
• A strategic lead, effective management, professional, clinical, educational, managerial and administrative systems for research nurses within the WTCRF and the Clinical Divisions (via the R&I Division).
• Strong leadership, effective management and professional advice to enable the delivery of high quality, GCP-compliant, research services by research Nurses.
As a member of the senior team in the Research & Innovation Division, the Lead Nurse will contribute to the delivery of the Trust research agenda aimed at promoting the clinical programmes of research and improving the quality, relevance and volume of research.
Divisional Research Managers
Each Division has a Divisional Research Manger who is available to
· Advise and support researchers in the development of new grant applications including liaison with the University and other Trust departments, Research Ethics Committees, etc.
· Support researchers to facilitate improvements in the speed of grant application approval by the Trust and University and securing Honorary Research Contracts
· Responsible with the Principal Investigator for the assessment of feasibility of new research to be undertaken in Division, including identifying required resources within applications, especially where these are outside of the Division
· Support the interface between clinical and research staff to facilitate the timely and efficient conduct of research studies
· Initiate discussions with clinical colleagues on possible research applications
Research Office
The Research Office is responsible for the operation of a number of systems to ensure that research conducted in the Trust conforms to all necessary legal, regulatory and ethical requirements.
Systems cover two main areas: Research Approvals and Governance & Quality Assurance, and The Research Office is structured to reflect these broad work strands.
Research Approvals
This work stream covers all activities relating to setting up and starting research projects within the Trust. This includes:
– Research notification and approval
– Contract negotiation
– Sponsorship agreements
– Honorary research contracts and passports
– Research database management and performance monitoring
Governance & Quality Assurance
The Governance & Quality Assurance work stream operates throughout the lifespan of a research project. Its work includes:
– Project design and facilitation
– Training
– Trial set-up
– Post-approval audit-ready assessments
– Research monitoring and audit
It is very important that there is access available to the necessary support for the conduct of high quality research, and the Trust supports its researchers in a variety of ways. The first point of call for research-related queries should always be the R&D Department where the team can help with many questions.
Research Governance
Research Governance is the name given to the management, standards of conduct, processes and systems related to research. Research Governance is not a single process; many activities and concepts are encompassed within it.
The main things to consider when conducting research in the NHS is that research must be:
· Ethical - with the rights and wellbeing of participants at its heart;
· Of high scientific quality and relevance;
· Conducted within all appropriate guidelines and legislation;
· Conducted by qualified professionals who agree to discharge their responsibilities in agreement with their research partners, within organisations that promote a quality research culture;
· Open to monitoring and inspection.
Guidance for standards and processes that constitute good research practice in the NHS were brought together and documented in the 2001 Department of Health publication, “The Research Governance Framework for Health & Social Care”. The Framework document and its annexes provide an overview of:
· Minimum expected standards for the initiation, conduct and dissemination of research;
· Management systems;
· Guidance on relevant legislation (including Clinical Trials regulations);
· Responsibilities of those involved in research;
· Requirements for the monitoring of research practice;
· Systems for dealing with poor performance and misconduct.
It should be emphasised that very little about Research Governance is new; it simply collates and documents existing standards and procedures for good research practice.
GCP Training
What is Good Clinical Practice (GCP)?
“A standard for the design, conduct, performance, monitoring, audit,
recording analysis and reporting of clinical trials that provides assurance
that the data and reported results are credible and accurate and that
the rights, integrity and confidentiality of trial subjects are protected”
ICH GCP Glossary 1.24
In order to standardise GCP, representatives from the pharmaceutical industries in the three major regions (USA, Japan, and Europe) created the International Conference on Harmonisation (ICH) and set up the ICH GCP guidelines. Since the EU Directive in 1997, all studies in the United Kingdom have to be conducted in compliance with ICH GCP.
Good clinical practice is the quality standard by which clinical trials must be performed, by detailing the processes required in the conduct of clinical trials. If not followed, clinical trial data can be rejected and found to be unreliable, therefore it is vital that all involved in clinical trials have a thorough working knowledge of GCP requirements and adhere to them.
GCP Training – CMFT:
To book a place on CMFT ½ day training (available monthly), please contact:
The research office on 0161 276 3565
More information can be found at http://www.cmft.nhs.uk/trust/training.aspx
GCP Training – North West Local Research Networks:
For details of GCP Training available in the North West, please contact:
Sarah Rickard – 0161 701 6947
GCP Training – Online:
To register, go to http://courses.epigeum.co.uk/gcp/home (CMFT or University of Manchester e-mail addresses only)
Information can also be found via the North West Training Bulletin at
http://www.gmra.org.uk/training.asp
The Wellcome Trust Clinical Research Facility
The Wellcome Trust Clinical Research Facility, Manchester (WTCRF) provides a supportive, participant-focused environment to host quality research of the highest scientific excellence from study design to completion.
Operational since July 2001, the WTCRF is situated on a site leased to the University of Manchester (UoM) by Central Manchester University Hospitals NHS Foundation Trust (CMFT) and has physical links with CMFT.
The WTCRF operates via a partnership agreement with CMFT, UoM, Salford Royal Hospitals NHS Foundation Trust (SRFT), University Hospitals of South Manchester NHS Foundation Trust (UHSM) and Manchester Mental Health and Social Care Trust (MMHSCT). Investigators from the five partner organisations have access to the range of clinical research services available at the WTCRF.
The clinical research staff can provide assistance in the study design and the logistics of running a study through the WTCRF. Clinical research nurses provide the clinical care for participants and undertake a wide range of invasive and non-invasive monitoring for research participants. Where a study protocol requires recruitment or research visits to be performed in participants' homes or on the ward, WTCRF clinical research staff can perform outreach visits.
NB: This is not a core service, outreach visits must be funded by the investigator.
Clinical Staff from the WTCRF also contribute to a range of educational / support services including
· Induction
· Mentorship
· Clinical skills training
· Student placements
Contact details
WTCRF 0161 901 67500
Website http://www.mhs.manchester.ac.uk/wtcrf/Clinical Research Networks for England
The NIHR Clinical Research Networks make it possible for all patients and health professionals across England to participate in relevant clinical trials.
The aims of the NIHR Clinical Research Networkare to:
· Ensure patients and healthcare professionals from all parts of the country are able to participate in and benefit from clinical research
· Integrate health research and patient care
· Improve the quality, speed and co-ordination of clinical research
· Increase collaboration with industry partners and ensure that the NHS can meet the health research needs of industry.
A number of networks co-ordinate clinical trials for specific conditions. These are:
· Cancer
· Stroke
· Mental Health
· Diabetes
· Medicines for Children
· Dementias and Neurodegenerative Diseases
· Primary Care – including disease prevention, health promotion, screening, early diagnosis, and the clinical management of long term conditions.
CMFT currently hosts the Medicines for Children Research Network (MCRN)which has the central objective of facilitating the development ofmedicines that are both safe and effective in the treatment of children. It will have a major focus on clinical trials but will also include other study designs relevant to the overall objective.
In addition, the NIHRhasestablished a ComprehensiveResearch Network to encourage clinical trials in all areas ofdiseases and clinical need within the NHSother than the specific conditions above.
The Greater Manchester Comprehensive Local Research Network (CLRN) is one of 25 CLRNs across England which forms part of the NIHR Comprehensive Clinical Research Network (CCRN). CCRN provides support for clinical trials and other well designed studies in all areas of disease and clinical need. Key contacts are