. MRes Clinical Research Course Handbook .

1. Course Title: MRes Clinical Research Course handbook

2. Welcome to Teesside University Wanting to expand your knowledge of clinical researchmeans that you care about the future of health care and its recipients, have a caring and inquisitive nature, love problem solving, question thingsand enjoy a challenge. At Teesside we have designed an innovative and interesting Course to help you reach your goal and like all Teesside graduates become confident, critical and creative, articulate, adaptable and aspiring. .

3. A warm welcome from the team You’ll find that we’re very keen to help you to make the most of your time here and as a starting point this handbook is designed to answer some of the questions that you will probably have at this time. On the following pages you will find information about the course itself, the delivery, and an over view of the modules including assessment dates. You will also find details of sources of support that you can access should you need to. Any further questions, please just get back to me, or ask one of your tutors listed here Name: Barbara Neil Role: Course Leader Module leader Clinical Trials and Dissertation Number: 384918 Email: barbara.neil@tees.ac.uk Name: Vicki Whittaker Role: Module leader Quantitative Research Methods & Analysis and Research Evidence Synthesis Number: 738281 Email: v.j.whittaker@tees.ac.uk Name:Rebekah McNaughton Role: Module leader Clinical research in Context Research Project Management Number: 382755 Email: R.mcnaughton@tees.ac.uk Name: Rachel Featherstone Role :Module leader Qualitative Research Methods and Analysis Number: 738212 Email: r.Featherstone@tees.ac.uk This handbook should be looked at in conjunction with the School Student Guide which provides important information relevant to all students in SOHSC and the University Student Handbook http://www.tees.ac.uk/sections/stud/handbook/

4. “What are the overall aims and outcomes of MRes Clinical Research?” This Course aims to: • Provide you with a broad and progressive education in Clinical Research Which will enable you to: • Develop the skills and experts necessary to undertake clinically relevant research • Acquire and develop transferable skills in order to create or respond to career opportunities or to undertake further study • Foster your commitment to your own intellectual and personal development.

5. “What should I be able to do by the end of my Course?” In terms of your research, knowledge and cognitive skills, you should be able to: In terms of your professional skills you should be able to: • Demonstrate a systematic and critical understanding of research governance and ethics applicable during both clinical trial development and in the management of clinical research projects. • Work proactively, to manage the implications of ethical dilemmas and to formulate solutions. • Demonstrate a critical understanding of quantitative research methods by designing and justifying appropriate robust methodologies to investigate complex areas of clinical practice and critically evaluate their effectiveness in a range of clinical contexts. • Demonstrate a critical understanding of qualitative research methods by designing and justifying appropriate robust methodologies to investigate complex areas of clinical practice and critically evaluate their effectiveness in a range of clinical contexts. • Select justify and utilise appropriate data analysis methods for complex, incomplete or contradictory data sets. • Synthesise and interpret data/evidence from a range of sources to provide reasoned argument and evidence-based conclusions to inform theory or clinical practice. • Justify the selection of appropriate research design, data collection, and data analysis methods required to answer a student identified clinical question via the production of a substantial dissertation. The intended aims and learning outcomes of your Course are listed here. When you graduate this is the kind of information that will be needed for potential employers. And in terms of skills that are personal and can be transferred to many different kinds of careers, you should be able to: • Use sound judgement to make evidence-based decisions reflective of clinical and academic contexts. • Develop the skills and qualities required to effectively communicate complex information, relative to clinical research and practice, to a range of audiences. • Demonstrate a sophisticated understanding of a range of digital environments and numeracy skills commensurate with clinical research.

6. How often do I have to attend? The course can be studied either full time (1 year) or part time (2 years) and successfully completing the course will mean that you have acquired 180 level 7 credits and be eligible for the award of Master in Clinical Research. The structure of both of these options are on the following slides You will also need to decide whether to study via the attendance, distance or flexible route. It is up to you to decide which mode of delivery fits in with your other obligations. Any of the team will be happy to discuss these options with you, and you can change your choice at any time, just let us know. You will find a little more detail about these 3 options on a later page. Just to note: International students on a visa are required to follow the attendance route only

7. FULL TIME ROUTE (1 YEAR) KEY RMH4040-N Clinical Research in Context RMH4041-N Qualitative methods RMH4042-N Quantitative methods RMH 4043-N Clinical trials RMH4039-N Research Project Management RMH4048-N Research Evidence Synthesis RMH4009-N Dissertation

8. PART TIME ROUTE (2 YEARS) YEAR 1 KEY RMH4040-N Clinical Research in Context RMH4041-N Qualitative methods RMH4042-N Quantitative methods RMH 4043-N Clinical trials RMH4039-N Research Project Management RMH4048-N Research Evidence Synthesis RMH4009-N Dissertation Year 1, semesters 1,2 and 3

9. PART TIME ROUTE YEAR 2 KEY RMH4040-N Clinical Research in Context RMH4041-N Qualitative methods RMH4042-N Quantitative methods RMH 4043-N Clinical trials RMH4039-N Research Project Management RMH4048-N Research Evidence Synthesis RMH4009-N Dissertation Year 2, semesters 1,2 and 3

10. What will I learn during the course? All of the modules on the MRes Clinical Research are studied at academic level 7. The course has been designed to provide you with the opportunity to develop the relevant skills and knowledge that underpins research within the wider context of health and as such open the doors to either a research or PhD career. You will be provided with the opportunity to explore a wide range of research methodologies, and the national and international context in which health research takes place. You will find more details of each module on the following slides, each module has its own guide which will be made available to you just prior to the start of the module.

11. The modules Quantitative Research Methods & Analysis (RMH4042-N): . This module will provide students with an understanding of experimental and observational approaches to research and methods of data collection.  Statistical techniques available to analyse data will be focused on, with emphasis on identifying the appropriate test/method and assessing the underlying assumptions associated with it.  The module will enable the student to critically interpret results and findings. (20 credits) Clinical Research In Context (RMH4040-N) The module is designed to prepare students to plan and conduct clinical research by providing them with a comprehensive and critical understanding of the principles and practices of clinical research and the contextual factors surrounding it.  There is increasing demand for high quality clinical research to underpin practice, and exciting new career pathways are available for suitably qualified practitioners to lead and develop this research provision.  This module is aimed at students who either work in a clinical research environment or who wish to develop research skills in a clinical setting.  Qualitative Research Methods and Analysis (RMH4041-N): .This module is designed to explore and contextualise the use of qualitative research methods based on an understanding of the theoretical and philosophical underpinnings of qualitative methodologies.  The focus of the module will be upon the use of qualitative methods in health and social care settings in order to access the subjective experiences of individuals. (20 credits) Research Evidence Synthesis (RMH4038-N): This module is designed to provide students with an understanding of all the steps necessary to undertake different types of evidence-synthesis for clinical research including systematic reviews, meta-analysis, best evidence synthesis or narrative reviews of qualitative or mixed methods research. It is also designed to further develop your ability to critically evaluate, integrate and apply evidence from research. (20 credits) .

12. The modules Research Project Management (RMH 4039-N) The module aims to introduce students to the principles and practices of effective research project management.  Research projects typically have three stages: the planning stage (where the methodological approach to be used is refined); the execution (or implementation) stage; and the dissemination stage.  This module focuses primarily on the second and third stages in the lifecycle of the research project including the effective management of Randomised Controlled Trials (RCTs). Dissertation (RMH4009-N) This module will enable you to consolidate, further develop and synthesise knowledge and skills gained during previous modules. You will work with a supervisor to identify a researchable problem, plan a realistic and appropriate methodology and execute either a primary or secondary research study. The dissertation can be written as a 15,000 word thesis or as research paper with a file of evidence Clinical Research Trials (RMH4043-N): This module will enable students to understand and apply appropriate principles and practices in relation to the design and conduct of randomised control trials(RCT’S). (20 credits) . You will be provided with a detailed module guide at the start of each module

13. How will I learn? The learning and teaching strategy has been designed to enable your development as an independent learner regardless of whether you are attending, studying at a distance or following a flexible route. A variety of learning and teaching methods are used throughout which encourage you to take an increasingly active role in your own learning as the course progresses. Flexible learners In recognition of the fact that most students need to combine their study with a full time job (and other commitments) this approach allows you to decide which weeks to attend and which to study at a distance. We just ask that you keep your tutor informed of any change in plan Attendance learners The learning and teaching methods include *Key lectures *seminars,*discussion groups *workshops and *lab sessions Distance learners You will follow the same delivery pattern as the attending students, the materials will be on the VLE. These will include *Narrated power point presentations, *written learning materials, *recorded lectures and *interactive learning materials. Support will be available via email, telephone or skype. Your individual module guides will provide more details about the learning and teaching strategies in relation to specific modules. Early in the course content you will be introduced to the concept of mastery and what it means to work at masters level.

14. We offer a range of learning environments and activities Lectures and briefings Lectures and briefings are used to impart knowledge to larger groups. These tend to be tutor-led and aim to inform, inspire and engage. But don’t expect just to sit and listen! These types of learning are not passive and include note-taking, question and answers and/or small group debate. They are usually illustrated by a wide range of media. Project-based learning Projects form the basis of your learning and provide a wide range of experience in various areas of the discipline. This is the basic form of staff/student contact and the projects vary in length and focus, depending on the material being covered. Staff will monitor, encourage, advise and guide you through your work and there are many opportunities for peer discussion. Remember learning is a 2 way process, your role is crucial!! Seminars and workshops Seminars enable structured discussion and analysis to take place between groups of students and a tutor. Seminars are interactive and they facilitate the free exchange of ideas through which you learn the process of argument and reason. At times you may be asked to present a short, researched talk on a particular subject, after which the group will discuss the matters raised. Personal Development Planning (PDP) Portfolio One of the great strengths of your Course is the way that it enables you to make sense of your learning through personal development planning. PDP sessions are embedded at every level of learning. You will work with your personal tutor to record your goals and reflections on your progress towards them, in the context of your career aspirations and your developing knowledge of clinical research. Independent learning This is a very important part of University life. Your success will depend on your ability to develop the skills that will enable you to learn independently, using your own initiative and resourcefulness to achieve your goals. All modules will have a large element of independent learning attached to them. This will involve reading around topics in more detail. The library have many dedicated “quiet” areas to facilitate this independent study. IT computer labs You can access these to search for evidence on the many data bases available, and for data analysis soft wear

15. Personal development plan (PDP) Personal development planning is an important part of the MRes course, this process will help you to focus on shorter term goals that when completed and combined help you to reach your overall goal of being awarded MRes in Clinical Research. The Researcher Development Framework is (RDF) sets out the skills and attributes that are required to be a first class researcher, this is used as a reference document to help you to plan your personal development in conjunction with your personal tutor. It is expected that you will meet at least once each semester with your personal tutor to track your progress PDP will be discussed in more detail within the first module Vitae Researcher Development Framework (www.vitae.ac.uk)

16. Who do I contact if I need support? We appreciate that despite best laid plans there may be times when you will encounter unexpected issues that could interfere with your learning experience . To help you to deal with these we have several supporting processes that you can access. Academic support If you are experiencing difficulty coping with the material in any module, please explain the problem to the Module Leader. It is primarily the Module Team’s responsibility to deal with these difficulties. If you can’t resolve the problem in this way, then you can approach the Course leader. Module leader details are at the start of this document Pastoral support If you experience any unforeseen problems related to either your other commitments or your health you should discuss this with your course leader of personal tutor. They will be able to advise on the most suitable support mechanism to follow. These support mechanisms are explained later in this document. Your course leader is: Barbara Neil (details are at the start of this document Your personal tutor is Barbara Neil (details at the start of this document)

17. Other sources of support Transition to Mastery The skills required to work at masters level are covered in your first module. e@t e@tis the University’s Virtual Learning Environment, accessed through the internet: https://eat.tees.ac.uk It is important that you actively engage in the use of the e@t environment. Here you will find lecture notes, activities and additional reading for each module. Each module has its own site. Library The library can be accessed remotely (lis.tees.ac.uk) As well as offering a wide range of books and access to journals you can also access many guidance notes (lib guides) and support workshops. Visit lis.tees.ac.uk for more detail of the support that is offered. Dissertation supervisor Prior to starting your dissertation you will be allocated a supervisor who will help to guide throughout the development of your dissertation

18. MORE SUPPORT FROM STUDENT AND LIBRARY SERVICES (SLS) Student and Library Services (SLS) contributes to the University’s outstanding student and learning experience by inspiring and empowering success for learning and life. SLS provides a holistic offer of support and advice including learning, research, welfare, health and wellbeing, whether you are on-campus or accessing online support. Student Life is your place to go for support, advice and collaboration to inspire and empower your learning and life. Online and in our new future-facing £12.5m Student Life building at the heart of campus, we’re here to help you get the most out of everything that university has to offer. Find out more: http://www.tees.ac.uk/studentlife The Library provides a high quality service based upon an extensive collection of digital and print resources, inspiring spaces for learning together with support from professional staff. The Learning Hub offers guidance to students on developing their skills as independent learners.  Guidance is available on a wide variety of academic skills, for example literature searching, referencing and writing. For further information see http://www.tees.ac.uk/depts/lis Within SLS we pride ourselves on the accessibility and sensitivity of our support services and adopt an approach that enables and empowers students.There are a range of self-help and informational resources as well as support facilities. These include welfare and financial advice and support, disability and mental health advice, faith and reflection service, professional counselling and international student support. For further information see our Student Support web pages: http://www.tees.ac.uk/sections/studentsupport/ SLS is committed to providing an inclusive and accessible sports offer to all students. There is a range of dedicated sporting spaces and initiatives, including a state of the art gym, floodlit 4G artificial pitch, climbing wall and a wide variety of sports clubs and societies. Further information can be found on the Sport and Wellbeing web pages: http://www.tees.ac.uk/sections/sport/

19. How will I be assessed To ensure that you are meeting the learning outcomes at the required level a range of assessment strategies are utilised Formative work is used to aid your learning. This is where you receive either a mark or some feedback but it does not count towards the final module mark. All of your modules will have an element of formative assessment or formative feedback The nature and submission dates of the assessments for the MRes are on the following 2 pages All modules are summatively assessed. Summative assessments will consist of Essays and reports of varying lengths Summativeassessments are marked and the mark counts towards the final module mark.

22. FULL TIME HAND IN DATES AND WEEKS

23. PART TIME HAND IN WEEKS

24. Assessment Regulations External Examining Students often ask questions about how we know that their degree is broadly of the same standard as degrees awarded for similar courses by other universities.  In the UK we have a system called External Examining which is one of several ways that we confirm that standards are met.  An External Examiner is generally an experienced lecturer from another University/Higher Education Institution, who offers an independent view as to whether the work of students on the course is of the correct standard.  The External Examiner does this by looking at a sample of work (e.g. assignments, exam answers, dissertations), discussing the work with your lecturers and normally attending the assessment boards to endorse results.  They then produce an annual report which highlights any good practice they have seen and allows them to report any concerns they may have. They also confirm in their Report that academic standards and achievement are comparable with the UK Higher Education sector.  The External Examiners’ reports are made available to students via the ‘courses’ tab in e-vision and are also considered annually at relevant Course Boards. The main External Examiner for your course is Miriam Mc Millan and they work at (insert place of work here).  Sometimes, your modules may have a different External Examiner and your Module Leader can provide details on request. • Please note that students are not permitted to contact External Examiners directly and External Examiners will not respond to any communication from individual students.  If you have any concerns about your course then please speak to your Course Leader.” Regulations (briefly) The Course is covered by standard University regulations applicable to any masters (level 7) work. All work is assessed in relation to the assessment criteria outlined in each of your module guides All work is first marked, and a sample will be moderated by an internal sampler. All dissertations are second marked. A selection of assessments will be viewed by an external examiner Unratified results will be released at a given point The marks will be ratified at an assessment board and you will then receive your ratified (final) mark . .

25. What if I cant meet the submission date? If the unexpected happens and you feel that you either cant meet the deadline or your ability to work at your full potential has been effected then there are several options open to you. Your first point of call should be your personal tutor who will discuss these options with you Submit the required paper work to module tutor and course leader You or a member of your family has been poorly and you just need an additional week to complete the work Short extension Long extension/deferral You or a member of your family has been poorly or your employment situation has changed and a week wont be enough time Both of these options require the relevant paper work to be submitted along with some evidence to support your application. These should be discussed with your personal tutor Something unexpected (illness/work commitment) means that your work may not be up to the required standard to pass the module mitigation

26. How do I provide feedback on my course • Your feedback is VERY important to us, it is used to enhance the quality of its learning and teaching The content for this module doesn’t really reflect the assignment requirements You said You will be asked for your feedback on each of your modules This may be via a request from the central feedback system EVASYS or from your module tutor There will also be an end of course evaluation, details of this will follow We would very much appreciate your engagement with these evaluation processes We have adapted the content to more accurately reflect the assignment We responded Our feedback to you We will feedback to you on a regular basis in relation to your progress. This could be *informally within seminars or tutorials *formally through the assessment feedback system

27. THE END? Not quite… Keep in touch via our Alumni AND See you soon when you do your PhD

28. DISCLAIMER The information contained in this Handbook is, as far as possible, accurate and up-to-date at the time of printing. The express permission of Teesside University must be obtained to reproduce any, or all of this publication, other than for personal use or for those purposes permitted by law.