Dissertation Guidelines (DH)

Transcription

1 Dissertation Guidelines (DH) for the MScCRA Version 1

2 All rights reserved The Dissertation Guidelines, in all its parts, guidelines, examples, layouts, appendices, technical notes, forms, images and any additional material, is a copyright of Laureate Online Education B.V. The Dissertation Guidelines For Students and Dissertation Advisors For the Master of Science in Clinical Research Administration Programme Version July,

3 CONTENTS 1 INTRODUCTION TO THE DISSERTATION MODULE Glossary / Personnel Learning Outcomes Overall structure The student and the Dissertation Advisor (DA) Outside help with language skills PLAGIARISM, COPYRIGHTS, CONFIDENTIALITY AND PUBLISHING Citations and plagiarism Copyrights and confidentiality Publishing and posting METHODOLOGY (STEPS, SCHEDULE AND DURATION) PART ONE: Formal requirements (The must do s ) Dissertation classrooms ( DA Office ) Submission of outline proposal Ethics applications Dialogue between student and DA Chapter drafts Submission of final Dissertation PART TWO: Recommended Key Stages (The should do s ) Phase 1 (Weeks 1 8): Phase 2 (Weeks 9 14): Phase 3 (Weeks 15 24): Phase 4 (Weeks 25 28): Phase 5 (Weeks 29-32): Phase 6 (Weeks 33 40): Throughout all stages: Access to the Dissertation support materials MScCRA Dissertation module materials folder GETTING STARTED PREPARATION FOR RESEARCH The topic to be investigated: Reviewing the background research Stating your aim and objectives/research question/assumptions Formulating your research question Deciding how you will carry out your research Planning your research timetable Obtaining ethics approval Expedited review: Full (Committee) review: The structure of your Dissertation Abstract Acknowledgements Introduction and background (Literature review Why do this work?) Methods (What did you do?)

4 Results (What did you find?) Discussion (What do your results mean?) Conclusion and recommendations (So what?) Reference list The appendices General format Presentation Word limit Title page Declaration List of abbreviations Contents page Regulations Intention to submit Typographical detail Pagination APPENDIX A: DA and Student: Working Relationship Summary APPENDIX B: Extension Application Process Dissertation outline approval Ethics application Final submission APPENDIX C: Assessment Schema APPENDIX D: Outline Dissertation Proposal Checklist

5 1 Introduction to the Dissertation module This guide should help you towards successful completion of your Dissertation. You are advised to refer to it regularly when planning, researching, and writing your Master of Science in Clinical Research Administration (MScCRA) Dissertation to ensure that it fulfils the University and Faculty of Medicine requirements. Glossary / Personnel Several Laureate Online Education/UoL administrative positions are referred to in this document according to their functions. The table below links the function/position title to the person who currently has that position. Position Academic Administration Coordinator (AA) Assessors Director - Academic Studies Director of Online Studies (DOS) Dissertation Advisor (DA) Faculty Staff Coordinator (FC) General Dissertation Advisor (GDA) Online Librarian Student Support Manager (SSM) Student Administrator (SA) Function The AA confirms receipt of your final submission and arranges assessors for submitted papers. The people who grade the dissertation after submission. The Dissertation Advisor (below) is the first assessor and a second assessor is assigned by Laureate Online Education The Director of Academic Studies is the University of Liverpool academic responsible for overall management of the programme of study. The DOS is the Laureate Online Education academic responsible for delivery of the programme online. The DA is the instructor that acts as the personal academic advisor for the student as they develop and write their dissertation. The Faculty staff coordinator supports the Instructors with administrative issues. The GDA is the instructor who teaches the Research Methods Training class. The Online Librarian is the University of Liverpool library assistant assigned to assist Laureate Online students. The Student Support Manager is the student s prime contact point for all non-academic issues. The SA is responsible for class creation and enrolling students and Instructors in class * onlinelibrarian@liverpool.ac.uk - 5 -

6 Learning Outcomes The purpose of the Dissertation is for students to develop and demonstrate broad clinical research administration knowledge and skills relevant to the MScCRA programme. Students must synthesise and integrate across subjects, selecting material and approaches appropriate to their specific area of study. The aim of the Dissertation is to conduct and write a piece of original research of relevance to clinical research administration. On completion of the Dissertation, students will have demonstrated ability, within a clinical research setting, to: Prepare and present a research proposal; Conduct a literature search and critically review literature; Plan and implement a small-scale research project relevant to clinical research administration; and Produce a clear and accurate written research report that conveys the clinical research administration context and implications. A Dissertation should generate new knowledge (or new applications of existing knowledge). This can include secondary data analysis, but not normally routine audit projects. Overall structure At the end of the sixth module, students are sent getting started information from their Student Support Manager (SSM). This information begins the process of supporting the student to identify a topic for their Dissertation in the context of the research ethics and the MScCRA requirements. (From April 2010, students who begin their Dissertation will be expected to have completed a self study, and a short module called Dissertation Readiness. This module is a short series of locked steps tested through multiple choice questions which aim to provide an important introduction to the basics: how to carry out literature searches; the overall Dissertation process; ethical issues; etc.) The MScCRA Dissertation (DH) process has an overall length of 9 months: 2 months within the introductory Research Support module (that ends with the production of the outline proposal); then another 7 months prior to submission of the final draft, including a minimum of 2 weeks for the Dissertation Advisor (DA) to review the final draft, and 2 weeks for the student to make any final changes prior to submission i.e.,, a month before the final deadline for submission. As within the other MScCRA modules, there is a procedure of applying for extensions on the basis of serious and unforeseen circumstances that have significantly interfered with the student s planned timeline. Requirements for ethics applications over and above the 1 month allowed will automatically be - 6 -

7 supported for extensions on application. All applications have to be made via the SSM and have the support of the student s DA. The details of the extensions application process can be found in Appendix B. The student will be enrolled in two Dissertation classes a Research Methods Training (RMT) class and a Dissertation Advisor (DA) class. The RMT class will be conducted by a General Dissertation Instructor (GDI) and will include other students enrolling in the same Dissertation cohort. The GDI will oversee the class and ensure that students are able to work through the research support materials (intensively for the first 2 months and then intermittently for designated activities over the rest of the Dissertation period). By the end of the first 2 weeks, Dissertation students will have identified their Dissertation subject, and by the end of the fourth week, they will have been assigned their own DA. Here, the student is enrolled into the second class with their DA. For the final 4 weeks of this introductory 2 months the students will focus on developing, revising, and submitting the outline Dissertation proposal with the help of both their own DA and their fellow students within the Research Support Class. The student and the Dissertation Advisor (DA) Throughout the Dissertation process, the input from the DA will vary according to the needs of the student. It is important that the student maintains steady progress and, especially at the beginning of the process, agrees to their specific timetable so that both the student and the DA are clear what is expected and when. A guide timetable is provided in this document as an example of the structure of the Dissertation process. However, this will obviously change depending on the nature of the student s Dissertation subject and design. The DA and the student should both read through the Working Relationship Summary found in Appendix A. This will need to be adapted to reflect each DA-student relationship, but is proposed as the basis of a signed agreement to which both the student and the DA commit. The first process that the DA will help students with is to define their outline proposal. The University of Liverpool sees the outline proposal as a key stage in the Dissertation process and has specific requirements that the proposal must address (see Appendix D: Outline Dissertation Proposal Checklist). The reason for this early emphasis is to ensure a strong foundation on which the rest of the Dissertation can develop smoothly

8 The DA s role in developing the Outline Dissertation Proposal is to offer advice and feedback on the required elements: The clinical research administration context and study aims The ethical issues and approval process Describing the study design, data collection and handling Data analysis methods The implications and relevance of the results to clinical research administration As the Dissertation progresses, the DA is expected to discuss with the student their ideas, read and comment on early well-crafted drafts of each chapter and then, when the whole Dissertation is drafted, comment on all chapters in relation to the overall work. It is important that the student arranges with his/her DA the stages at which s/he can allocate time to read and discuss draft(s) well in advance, otherwise a great deal of time may be wasted for both. Students should not expect their DA to comment on more than the proposal and two drafts of the Dissertation (as complete drafts or their component chapters). The student should check the accuracy of all drafts for typography, grammar, spelling, formatting, referencing, and data presentation before asking for comments on them. It is the student s responsibility to correct any such errors. The examiners will pay particular attention to such problems in presentation. Authorship and potential future publications please note that: Although the Dissertation is ultimately the student s own work, the DA is likely to contribute considerable time and expertise to the development and writing of the Dissertation. If students subsequently submits the material for publication, for example, as an article in an academic journal, they should not omit any authors who fulfil the international authorship criteria 1 : Substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data Drafting the article or revising it critically for important intellectual content Final approval of the version to be published Ahead of starting to draft such an article, the student should at least discuss with the DA whether his/her contribution to the Dissertation merited authorship of any intended article and whether anyone else qualifies as a potential author. The final responsibility for the quality of the Dissertation rests with the student, but the DA takes responsibility for providing sound advice along the way. The student is also responsible for keeping in touch with the DA. The Working Relationship Summary should be discussed and agreed upon during stage 1 International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. Philadelphia: American College of Physicians, (Last accessed September 2007 at:

9 one of the Dissertation as this outlines the responsibilities of both the student and the DA. The DA is responsible for updating the core team about student progress, via the monthly reporting mechanism. If a student is unhappy about any aspect of his/her supervision, s/he should consult the Student Support Manager as soon as possible. It should be noted that a fee may be imposed if the student wants to change his/her DA after the Outline Proposal has been approved. The student will need to submit a request to the Student Support Manager (SSM) if s/he changes DA at this stage. The SSM will discuss this request with the student s DA and the Director of Online Studies (DOS), and a decision will be made as to whether the change requested can be achieved. Outside help with language skills The writing as well as the work presented should be the student s own. It is acceptable for the student to ask the DA when reading a chapter to point out unclear sentences, problematic paragraph structure, etc., but it is clearly unacceptable to give the text to a professional editor for corrections. Even the most minor assistance should be clearly acknowledged in the Dissertation preface (see the declaration at the beginning of the DH template file which is an integral part of the DH package). It is not permissible to write the Dissertation in another language and have it translated into English. The University of Liverpool will treat the use of a professional editor as unauthorized collusion. 2 Plagiarism, Copyrights, Confidentiality and Publishing Citations and plagiarism The importance of proper citation in all stages of the project cannot be stressed enough. The Dissertation is to follow the same requirements for proper citation that were applicable in the other modules of the programme. Students must use the Harvard system as explained later in this document and as promoted throughout the programme. Proper credit to other sources should be present in the proposal and then continue throughout each stage of the Dissertation. Proper citation must be an integral part of the final thesis. Failure to adhere to the citation rules, which are simple to follow, will most likely be considered as plagiarism. The final draft of the Dissertation will be submitted to the DA by the student (via one of two dropdown boxes in Blackboard) for the DA to do a final review. The draft will pass through the Turnitin application that checks for plagiarism. The final Dissertation will be submitted for assessment (via the second dropdown box) for the two assessors (the DA and a second assessor). They - 9 -

10 are obliged to inform the academic department of any suspicion of plagiarism or collusion. An explanation will be requested from the student, and this explanation, together with the other evidence taken from analysis of the Dissertation, will be brought to the Board of Examiners (BoE) when it considers the assessment of the Dissertation. The Board has the power to decide what final result should be recorded, in the light of the evidence, and also to consider whether further action is necessary. Thus, great care should be exercised when posting the final Dissertation document, as no additional submissions or corrections are allowed after the final draft is submitted. Missing citations and references will not be allowed to be added late to any document. For more information, please see the Plagiarism and Unauthorised Collusion Policy in the Student Handbook. Copyrights and confidentiality There are two separate issues regarding copyrights: a) What is the copyright status of a student s Dissertation and to whom does it belong? Traditionally, all academic work completed at a university will be owned by the university. Usually it is beneficial for them to share the credit with the student, and even though they don't have to technically, most universities choose to do this. Due to most of the University of Liverpool Online Higher Education/Laureate (UoL/Laureate) students being active working professionals, often using their companies/organisations as case studies, the ownership of the Intellectual Property Rights (IPR) becomes a little more complicated. The UoL/Laureate official stance is: 'Except in the case of students supported by outside bodies, where specific provisions relating to intellectual property are embodied in the conditions of the support, all postgraduate students are required to agree to assign to the university all their rights to intellectual property arising from their studies or research at the university... the University has a policy of sharing profits arising... with the staff and students concerned'

11 The most relevant section here is 'except in the case of students supported by outside bodies', as most UoL/Laureate students are employed and so supported externally. However, it is also believed that: 1. They (students) are the effective copyright holders of their Dissertation. Other than placing a copy in the library, the University/Laureate will not publish their work without their consent. 2. Any published work arising out of a Dissertation project should normally be viewed as collaboration between the student and the supervisor, and each has an obligation to discuss this with the other, and to agree on authorship and/or acknowledgements as appropriate. The UoL/Laureate has no rights over any such publication, but it is expected that it will include an acknowledgement that the work was carried out as part of the student's studies with the UoL/Laureate. 3. In the case where a student's Dissertation project is sponsored by their employer, or relates directly to their employment, the UoL/Laureate will not make any claim on the IPR of the work. 4. In any other case, the student is required to inform the UoL/Laureate if any commercial exploitation of work carried out in the Dissertation is planned. The UoL/Laureate will not normally assert its claim to IPR, however, unless there is a reasonable argument that the Dissertation supervisor should share in the benefits of any exploitation. The most important factor to consider is probably that it is not in the interests of the UoL/Laureate to forcibly claim rights over a piece of work or information. At most, the UoL/Laureate will request acknowledgement that the work was carried out as part of the student s studies with the University. (b) The second issue regarding copyrights has to do with what is permitted in terms of quotations, etc. within your Dissertation. The University of Liverpool policy can be found in the following publications: A basic guide for staff and students of the University of Liverpool Further guidance about acceptable use of electronic Library resources is available at: A list of contacts:

12 Confidentiality: Students who need to keep their Dissertation confidential should include the following sentence on the same page that they make their declaration about plagiarism: This Dissertation contains material that is confidential and/or commercially sensitive. It is included here on the understanding that this will not be revealed to any person not involved in the assessment process. Inserting this statement will also preclude the Dissertation from being placed in the Dissertation Library. Publishing and posting All documents concerned with the progress of the Dissertation during the Dissertation process (proposals, monthly reports and interim Dissertation drafts), are internal documents submitted to the University for assessment. They should thus be regarded as coursework assignments which belong to the UoL/Laureate rather than to the student. In particular, the Dissertation is an internal document until after final assessment, at which point it becomes public. 3 Methodology (Steps, Schedule and Duration) The overall duration of the Dissertation module is 9 calendar months from initiation (classroom allocation) to submission, beginning with a concentrated 8-week block of participation with other students within the same Dissertation cohort. This section provides guidance on the key steps to be taken by the student in the development, doing, and eventual submission of the Dissertation. There are two parts to this section. Part One provides a summary of the formal requirements (the must do s ) in terms of the administrative processes and key milestones that govern the whole process. Part Two sets out a series of ( should do ) key stages that the student is strongly advised to adopt in order to ensure a suitably structured approach to the whole process. PART ONE: Formal requirements (The must do s ) After starting the seventh credited module, the Student Support Manager will send an with a reminder to start to prepare for the Dissertation module and to review the My Dissertation materials. Once notified, students should access My Dissertation in ohecampus and familiarize themselves with the materials and guidelines. Please note that students cannot take a break between modules for a period longer than 16 weeks without special authorization. This means that students have approximately 4 months (i.e., 16 weeks) after finishing the last module to start working on the Dissertation

13 Dissertation classrooms ( DA Office ) The Dissertation begins with the 8 week Research Methods Training (RMT) phase with other students beginning their MScCRA Dissertation at the same time. Four weeks into the RMT phase, the student will have confirmed their Dissertation subject, will be assigned a DA, and have access to their DA classroom. Please note that a DA will probably be assigned rather than chosen by the student as we have a limited number of DAs and it will be important to get the right match for the student as well as the right balance and number of Dissertation students for the DA. All the correspondence between students and the DA should be conducted through the individual classroom that is shared between them. Once in the classroom, the student will be reminded to repost any important prior messages e.g., the Academic Honesty Declaration, which is part of the Week 1 folder. At the end of the initial 8-week RMT phase, the student will have submitted his/her outline proposal via their DA to the Outline Proposal Review Panel. See below for further details. Participation in the cohort class initially within the RMT phase and subsequently within the designated, monthly activities has a pass to progress requirement. This means that the student must participate adequately (as judged by the General Dissertation Instructor supervising the cohort class) to progress to the next phase of the Dissertation. The aims here are to (a) further develop students research skills by learning from colleague students about their research, and (b) provide a structure and a healthy degree of peer pressure to sustain consistent progress in what past students have found a very lonely and unstructured process. Submission of outline proposal The outline proposal development will take place within both the Research Methods Training classroom and your individual classroom with your DA. Submission of the outline proposal will take place within the DA Classroom, to the student s DA. Once the DA believes that the outline proposal has reached a stage that will gain academic approval, the DA submits the proposal to the Review Panel

14 This Review Panel is made up of DAs, members of the University of Liverpool on-campus team and the Director of Online Studies (DOS). Feedback will be provided via the DA within 10 days. The outcome of that feedback will be one of three possibilities: 1. Approval 2. Approval subject to minor amendments that can be signed off by the DA and the Review Panel do not need to see the proposal again 3. Not approved, further work required, and resubmission to the review panel It is important for the DA and the student to view the Review Panel process as an opportunity for learning and academic rigor. Often when two people are engaged in developing the proposal, they can become so focused on the subject that they can miss elements. Hence, the Review Panel can offer a fresh and objective perspective. It is worth noting that the initial submission of the proposals might be returned requiring further work. If this occurs, clear feedback will be provided pointing out how the Outline Proposal could be improved. Once the Outline Proposal has been approved, you should begin the development of your Dissertation. Outline proposals must be submitted by the end of Month 2 (a date is set for each cohort see the Personal Planner in the cohort Research Methods Training classroom, under module materials), and should be approved by the end of Month 3 at the latest. If the student has failed to either submit or gain approval by the third month, his/her SSM will refer him/her to the Academic Progress Committee. If the outline proposal is not approved by the end of Month 4, the student will fail the Dissertation. Obviously, if there are mitigating circumstances, the student will inform his/her SSM who will advise the student of the process to gain an extension. This should be done as in other modules at the earliest opportunity. For further details, see Appendix B. Ethics applications All students will be required to complete a UoL/Laureate ethics application form. The DA will determine if it requires Committee on Research Ethics (CRE) approval. The DA will submit the application to the Ethics Approval Panel once he/she judges it as ready for review and following approval of the outline Dissertation proposal. For full details, see the Getting started section. If the student has a local country or area ethics process, the student will also have to make application there. Normally, this is done in parallel with the UoL/Laureate ethics application. However, both processes are required and the application is judged independently by the UoL/Laureate Committee on Research Ethics. Throughout the preparation for the Dissertation, the student is being advised to steer away from ethically sensitive research topics/design. This advice is given with the intention of minimising the time taken to complete the Dissertation i.e., within the 9-month period. However, if the student following consideration of this advice chooses to select an ethically sensitive topic

15 and/or design, the process for gaining ethics approval via the UoL/Laureate and the local area/country ethics approval process will take longer often many months longer. Although applications for extensions based on documented waiting time for ethics approval will be favourably reviewed by the Academic Progress Committee, the student is still strongly advised to avoid ethically sensitive topics/research designs for the MScCRA Dissertation. Dialogue between student and DA The target turnaround time for the DAs responses to questions posed by the student is within 4 days, and within 10 days for feedback on draft chapters. Past experience has shown that work should proceed in well-planned steps and intermediate results should be shown to the DA. The completion of your own research time table is a key early activity: specifying your own milestones, agreed and signed off by your DA so that each of you can plan your time accordingly. All discussion should be done in the DA classroom. This is very important as with other modules the quality of teaching and student effort is regularly monitored by the DOS and subsequently by the UoL/Laureate Monitors and the External Examiners (EE). Chapter drafts Submission of initial chapter drafts should be included in the planning of any Dissertation. This will allow the student to gain feedback on each completed chapter before submitting a final full draft of the Dissertation to the DA for comments. If a student decides to submit a final full draft (this is highly recommended), s/he should allow at least 1 month for this phase (submission to the DA, 10 days turnaround from the DA and time then for the student to make any suggested changes prior to the final Dissertation submission date). This draft should be submitted in one of the two drop down boxes to check the Dissertation through Turnitin. Submission of final Dissertation Submission of the final Dissertation document should be made on or before the Dissertation deadline. The completed Dissertation should be posted through the second dropbox in the DA Classroom. The student must also click on the appropriate button to declare that the thesis is submitted in myohecampus. This must be completed for the Dissertation to be graded. Please be aware that failure to complete this notification of submission could lead to a penalty for late submission. Once the final submission has been made, this marks the point at which communication between the student and the DA should end so that the grading process can begin. The student should monitor his/her classroom for 4 weeks after receipt to address any questions that may arise as part of the grading process.. Your dissertation will then be marked by your DA as the first assessor and by a second assessor appointed by Laureate. Once the final submission has been made, you will receive an confirming the receipt of your dissertation. This contains the final acceptance of your

16 dissertation and marks the point at which communication between you and your DA should end so that the grading process can begin. A second assessor will be assigned and added to the DA class. You will be informed who the second assessor is, and the second assessor will introduce himself/herself to you in class. As part of the process the second assessor, and sometimes the DA acting as the first assessor, may ask you to answer a few questions in order to clarify the work presented and to assess the student s depth of understanding of it. The assessors will coordinate the date when the questions will be posted with you, and you must provide response within one week. When the assessors have no more questions to ask, he/she should inform the student, by placing a message and a note in the DA class, so you will not have to continuously access the system in search of additional questions. Grading will continue for several weeks once the dissertation is complete. Final grades will be released to you as soon as possible after the Board of Examiners has met and agreed on a final award. This could mean a wait of several months, depending upon the deadline and submission date of the dissertation. You will be contacted by your Student Support Manager with official confirmation of the results, once the Board of Examiners has made its decision. PART TWO: Recommended Key Stages (The should do s ) The Dissertation project carries 60 credit points, the same weight as four regular modules. Writing a Dissertation is a creative process, and it does not progress along a straight path. As a guide the student is expected to spend about 600 hours of work on the Dissertation. One of the most important requirements is that the Dissertation must be completed as scheduled. The deadline is 9 calendar months, from the date the cohort classroom was initiated. The student will be penalized for late submission (grade capped at C ) and will Fail if they are more than 1 month late. Extensions will not normally be granted, except in clearly unexpected circumstances beyond student control, such as waiting for ethics approval over and above the expected 4 weeks and/or in cases of real personal/ family/ medical/work emergencies. As stated earlier, the case for an extension will need to be made in writing with supporting documentation. Such requests should be sent to the Student Support Manager (with the support of the DA gained and posted within the DA classroom), who will approach the Director of Online Studies for approval via the Academic Progress Committee (see Appendix B). The Dissertation calls for less online attendance than the regular core and elective modules. There might be periods of intensive interaction such as when you are writing chapters, when applying for ethics approval, starting the field work, etc. Nevertheless, it is strongly suggested that students keep an

17 ongoing dialogue with their DA along with the required participation within the cohort Research Methods Training class using both to gain feedback, ask questions or simply swop experiences and discuss progress. Feedback from previous students suggests that the timetable and maintaining regular contact with the DA and other Dissertation students is really important to successful completion within the time available. Timings can vary greatly depending on the nature of the design, the need for ethics approval, and/or the practical requirements for data collection. Once data are collected, again timing will vary, but those stated are to try to help the student plan realistically in order that they can complete the Dissertation according to schedule. It is strongly recommended that students adopt the following framework as a template to ensure a suitably structured approach to tackling the key stages required for successful completion and subsequent submission of the Dissertation. Phase 1 (Weeks 1 8): This phase is probably the most interactive and structured of the entire 9 months. Students do some quick introductions, exchange of bios, etc and then work through the Research Methods Training materials. These materials aim to provide students with a reminder of key information and support, clarification of expectations, and a review of their proposed subject area. This comprises the first 4 weeks spent within the cohort class in much the same way as previous modules have worked, but with a much lower level of assessment. The second 4 weeks of this phase are focused on testing out proposal ideas and methods with other students in a similar format to a Discussion Question (DQ). Based on their chosen subject area, students will be assigned a DA and a class through which all the communications with their DA will take place. This runs in parallel to the cohort class for the rest of the Dissertation. Initially students will be asked to post their brief proposals in the Research Methods Training class to gain feedback from as many of the other students as possible. Students will probably be expected to comment substantively and constructively on at least two other outline proposals in each of the 2 weeks when this activity takes place within the cohort classroom. Students will receive feedback on their comments and on the comments other students have made on their proposal from the GDI overseeing the cohort class. It is expected that the outline proposal will be submitted to the student s own DA at the start of the fifth week, and students will receive feedback from their DA as to whether the proposal is approved. Students may or may not be required to complete further work. Whilst awaiting feedback from the DA in parallel, students will be further reviewing and expanding the initial literature review (completed for the outline proposal) and refining their research questions. Finally, when the proposal is

18 satisfactory, the DA will submit it to the Review Panel who will respond within 2 weeks. Hence, by the end of the second week of Month 3, the outline proposal should be approved. If resubmission is required, then obviously more time will be taken at this stage. Phase 2 (Weeks 9 14): Once the outline proposal has been approved, the ethics application can be submitted, if necessary. In the event that it is required, the ethics approval process takes approximately 6weeks: up to 3 weeks for development of the application (which will require many of the practical elements of the research; participant information, consent forms, etc.) and up to 3 weeks waiting for approval by the Committee on Research Ethics (CRE). Whilst awaiting outcome by the CRE, it is expected that students will complete their own Dissertation timetable and sign this off with their DA. In addition, students are expected to be further refining their study design and methodology and also be planning their field work/ collection of data, in anticipation of gaining CRE approval. If students have a local country or area ethics process, then students will also have to make application there. Normally, this is done in parallel with the UoL/Laureate ethics application. However as stated previously, both processes are required and the application judged independently by the UoL/Laureate CRE. Depending on when students submit their ethics approval application (see section below), a minimum of 4 weeks awaiting the outcome should be anticipated. Students cannot begin collection of data until ethics approval has been authorised by the DA, following UoL/Laureate ethics application approval, and where necessary posting local ethics approval (see below Getting started preparing for research ). Phase 3 (Weeks 15 24): (CRE approval to completion of the data collection and initial analysis) The aim for this stage is the completion of field work/collation of data. The key output is the submission of your draft introductory chapter to your DA (allow 2 weeks for the DA to read and comment); detailed analysis of data and initial results; and a summary of the methods used and the results achieved draft to DA (allow 2 weeks for the DA to read and comment). Phase 4 (Weeks 25 28): (Detailed review of results and discussion of implications) Post a summary of the main results and implications to the Dissertation group in order to present your findings, your view of the implications, and obtain their views (allow 2 weeks in the Dissertation group). Phase 5 (Weeks 29-32): Draft Discussion chapter and send the draft to your DA for feedback (allow 2 weeks for the DA to read and comment). Phase 6 (Weeks 33 40): Receive feedback from your DA on the Discussion chapter and complete revisions where required

19 The submitted Dissertation must be written according to the guidance given in the section The structure of your Dissertation. The DA must receive notice that you intend to submit your draft Dissertation as planned at least 2 weeks before submitting the draft. A complete draft should be sent to the DA at the start of Week 36 at the latest, so that there will be ample time for corrections and revisions i.e., 4 weeks prior to the agreed submission date. The final submission will be evaluated by two assessors as stated earlier. Throughout all stages: As stated in the previous sections of this guide, the student and DA should review the due date for the next stage at each stage of the process, and this should be reported in the monthly Status Report. Students should be aware that the ability to keep to agreed deadlines is a key ability for the clinical research administrator. Each activity of the Dissertation will be carried out in full consultation with the DA, who should be willing to discuss submitted section drafts before the final delivery date. Students should have their DA approve submitted sections before proceeding to the next section during the writing of the Dissertation. It is recommended that each stage should also meet the satisfaction of the DA before the next stage is started. It is extremely important that a last draft of the Dissertation be submitted to the DA before the final Dissertation submission. The DA will normally comment in detail only on a single, full last draft before the final submission of the Dissertation. Access to the Dissertation support materials MScCRA Dissertation module materials folder Dissertation guidelines the file that you are reading now Dissertation submission declaration MScCRA Dissertation categories and example titles Academic Honesty Declaration Acknowledging proper behaviour concerning plagiarism and collusion Ethics committee checklist

20 4 Getting started preparation for research Please note: This is written directly for the student as a step by step guide. The topic to be investigated: Members of the University of Liverpool clinical research staff have suggested broad research areas of their own current interest which they believe will offer topics suitable for feasible dissertation projects. If a student opts for one of these, he/she can expect to be directly supervised by UoL staff or receive indirect support from UoL through his/her DA in formulating a precise research question and acceptable research methodology.. YOU ARE STRONGLY ENCOURAGED TO CHOOSE YOUR DISSERTATION TOPIC FROM ONE OF THESE AREAS on the grounds of feasibility and efficiency alone. Please be aware that if you chose to follow your own research interest, rather than an area suggested by university research staff, you must be able to defend both the scientific merit of your question and develop an approved research methodology both of which may entail substantial additional time for the proposal review and approval process. As you will devote so much time to your Dissertation, it is essential that you choose a topic that you will enjoy and find interesting. It is also important to consider the practical aspects of the proposed study. Some topics may simply not be researchable because the necessary skills, procedures, and techniques are not feasible, available, or ethically acceptable, or would take too long, or involve too many people. In addition, you should consider the value of the proposed study in terms of providing new and meaningful insights. This may contribute to your own career development and may provide material for a peer-reviewed publication or preliminary work for a higher research degree. Looking at potential Dissertation titles might help you to choose your topic. Gaining ethics approval is a must do if the research involves human beings, human tissue or human data. In order to obtain ethics approval quickly and so without complications, it is important to choose a non-sensitive focus for your Dissertation. The list of proposed Dissertation categories and titles aims to guide you towards a non-contentious topic in order that your application for ethics approval can be looked at within the expedited rather than the full committee route. Students are required to share their Dissertation ideas within their Dissertation group, in order to receive feedback on their ideas from the group and DA prior to submitting a formal outline proposal of no more than two pages to the DA, who once satisfied with the proposal, will forward it to the DOS for final approval

21 The outline-proposal should be no more than 2 pages in length and the format should be as follows: 1. Title 2. Introduction and background (1 paragraph) 3. Summary of relevant literature (1 paragraph) 4. Research question 5. Study aim and objectives; and assumptions made about the nature of knowledge 6. Methods (including summary of study design; data collection and setting; ethical aspects/expertise available/data protection/confidentiality issues) 7. Research outcomes (1 paragraph) 8. Costs 9. Draft timetable 10. Key references The appendix of your Dissertation MUST include the final, approved, outline proposal. Please use the Oultine Proposal Checklist to aid successful completion (See Appendix D). Reviewing the background research It is essential to review the relevant literature to inform your hypothesis, research question/study aim(s). This will provide you with a sound theoretical basis, ensure that your proposed topic has merit, and will suggest alternative methods and techniques for conducting your research. A comprehensive review of previously published research should inform your approach and prevent time-wasting. There are a number of practical tips when searching through the literature: Use the collections of the University of Liverpool Online Library to access e- journals, e-books and databases. These are available through the University portal and the Online Library home page The Library contains important databases for your research such as OVID (Medline), Global Health, ProQuest Nursing & Allied Health Source, ScienceDirect, and Web of Knowledge. If you are not sure how to access this information, ask the online librarian: onlinelibrarian@liverpool.ac.uk Discuss your keywords and search strategy with your DA, together with likely sources of grey literature. Do not forget to search sentinel articles for useful references and to check whether their keywords help you to refine your search strategy. There are also some search tips on the Library Web site that might help

22 Consult relevant reference books. Regularly review current journals for articles that may be relevant. Consult other (local) sources such as previous MScCRA, MPhil, or PhD Dissertations. Do not forget the opportunity provided by local libraries for obtaining information. Stating your aim and objectives/research question/assumptions It is essential that you clarify the aim of your research. You need to develop a clear idea of what you are hoping to investigate and how this is to be done before you start your research. It might be helpful to start by trying to articulate the overall research question that you are interested in tackling. The study aim(s) and objectives are crucial to your proposal. The study aim should describe the overall purpose of the project and the objectives should outline specific elements (not methods). Keep the objectives concise and restricted in number. Long lists of objectives result in (or from) confusion and do not get done! The objectives can often take quite a while to get right, so do not be surprised or disheartened by the iterative process involved in designing them. If your study involves testing a hypothesis, define your hypothesis clearly and ask yourself whether the hypothesis is testable and whether the proposed study is feasible. Be aware that how you frame your research question and, for example, whether or not you have a hypothesis to test will be guided by certain assumptions that you make about the nature of knowledge / the truth and possible study design. You need to note what assumptions underpin your work and clarify the implications for your research approach and findings. In the Dissertation, this can take the form of several concise statements (with a clear link to the reflective parts of the discussion), or be a lengthier reflective discourse integrated in the relevant sections, as appropriate. Formulating your research question It is usually crucial to identify a clear research question before starting the study. The research question is simply the question that you intend your study to answer, in part or in full. It should follow on from the previous research questions identified by the studies in your literature review and should provide an overview for the study aim and objectives that you have identified. You should try to articulate one overall research question. Deciding how you will carry out your research Once you have carried out a thorough literature search, you must then formulate a plan for conducting the research. First, consider the main research design, e.g., whether the research involves, for example, a descriptive, analytical, or intervention-type quantitative study design, a qualitative approach, a mixed methods approach, etc. For surveys involving questionnaires, you need to plan the instrument very carefully and this can take a lot of time, especially as you should allow time for piloting. Discuss and

23 obtain advice from your DA as soon as possible and keep testing out your new ideas. Having formulated your study design, you then need to establish how the data are to be analysed, e.g., using appropriate statistical tests, clarifying the philosophy underpinning any analysis of data collected by a qualitative approach. Try to avoid complicated research designs or studies that involve long or indeterminate waiting-times to receive data from (especially multiple) routine data sources. If you need epidemiological, statistical, social science, health economics, management advice, etc. seek such advice from your DA at the design stage. Do not wait until you start your analysis. Once you have a clear idea in your mind of the design and methods of data collection and analysis, you should consider how many participants/cases will be included in your study, if they are required. This will be influenced by the feasibility given the overall time involved and the requirements of your particular study. You may already have a clear idea of the numbers that you require from previously published literature, but you must demonstrate a clear rationale, other than just feasibility, for deciding on that particular sample size and type. If in doubt, take advice. Do not forget to consider the cost of various components including, for example: travel, telephone, stationery, survey forms, etc. Planning your research timetable It is essential in planning research that you specify the estimated length of time required at each stage. Obviously, you cannot be exact in your time predictions because all sorts of unforeseen circumstances may cause delays. Obtaining ethics approval, for example, can take more than a few weeks and can involve numerous changes to your original intentions. Hence, it is better to take this into account right at the beginning in formulating a non-senstive focus. A timetable enables you to plan the project, and focus on its essential components. Remember that wishful thinking at this stage can lead to serious stress later. Obtaining ethics approval Complying with legal and ethics guidance and specific local or other codes of practice regarding use of all personal data is a requirement of the UoL/Laureate. Any research study that involves access to human participants, human tissue, or identifiable data derived from human participants will require primary ethics approval by a research ethics committee in the researcher s local jurisdiction and secondary review by the University of Liverpool/Laureate Research Ethics Committee. Depending on which country you are carrying out the Dissertation will determine the necessary ethics approval. Please do check this out thoroughly. This also applies to the organisation within which your study is carried out: Do they have a specific ethics approval procedure?