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DRPS : Course Catalogue : Deanery of Molecular, Genetic and Population Health Sciences : Molecular and Clinical Medicine

Postgraduate Course: Study Design (20 Credit) (MCLM11022)

Course Outline
SchoolDeanery of Molecular, Genetic and Population Health Sciences CollegeCollege of Medicine and Veterinary Medicine
Credit level (Normal year taken)SCQF Level 11 (Postgraduate)
Course typeOnline Distance Learning AvailabilityAvailable to all students
SCQF Credits20 ECTS Credits10
SummaryThis 20-credit elective normally constitutes the last taught course on the clinical trials programme before the MSc dissertation. Study Design is an essential component of a successful clinical trial. the aim of clinical trials is to answer specific clinical research questions and the study design is critical to ensuring that the data is selected, collected and analysed correctly to address the trial aims.
Course description Study design is an essential component of a successful clinical trial. The aim of clinical trials is to answer specific clinical research questions and the study design is critical to ensuring that the data is selected, collected and analysed correctly to address the trial aims. The Study Design course on the MSCCT will provide course participants with a thorough and practical grounding in the research and design process of a successful clinical trial. This process is defined by the following actions which participants will engage with directly:

performing a systematic review
carrying out a quantitative synthesis of trial data
formulating and developing a research question that can be addressed by a clinical trial
developing and designing a protocol for a clinical trial
developing the skills to interpret trial data.

Building upon the topics studied and opportunities to apply theory into practice in the Year 1 MScCT course, Introduction to Clinical Trials, this course is designed to provide a substantial further development of the participants┬┐ practical skills and critical understanding of study design techniques and methodologies. Statistical analytical skill in the interpretation of trial data and application of meta-analysis. The successful candidate will exit the course with the knowledge and skill to construct a robust research question and design a clinical trial, and synthesis results.

The main course themes will be presented in three Units:

Unit 1 Systematic review/RevMan5.3

Unit 2 Meta-analysis and trial design

Unit 3 Qualitative research

Unit 1 begins with an introduction to the methodology and approach to performing a systematic review followed by hands-on opportunities to practice identifying existing relevant research literature in a specific area. This is a key skill when formulating a research question, since it would be unnecessary (and unethical) to design and embark upon a clinical trial that was exactly the same as one that had been done previously or that is of no interest clinically or academically.

With the robust and comprehensive knowledge of existing research and practical skill of conducting a systematic review attained in Unit 1, in Unit 2 the course participant is ready to formulate a research question and design a clinical trial. Key elements of trial design analysis and reporting are applied including a plan for the statistical analysis of real trial data and its summary report.

Unit 3 begins with an introduction to qualitative methodologies to set the scene, then moves onto to a lecture on understanding what can qualitative methods add to clinical trials. This is followed by a practical and critical appraisal of mixed method clinical trials: and how to practically evaluate the contribution of qualitative methodologies to clinical trial study design.

For the assignment you will be asked to critically appraise, i.e to outline a list of three strengths and three weaknesses of a designated mixed methods paper. Each student will be asked to post these on the discussion boards and will these will be discussed on the discussion boards.

At the end of the course the participant will be in a firm position to formulate a research proposal and undertake a successful Masters dissertation.
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Additional Costs 0
Information for Visiting Students
High Demand Course? Yes
Course Delivery Information
Academic year 2023/24, Not available to visiting students (SS1) Quota:  None
Course Start Flexible
Course Start Date 05/08/2023
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 200 ( Seminar/Tutorial Hours 5, Online Activities 100, Feedback/Feedforward Hours 40, Formative Assessment Hours 12, Summative Assessment Hours 10, Revision Session Hours 8, Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 21 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) Assessment is undertaken throughout the course with each element structured to provide opportunities for formative feedback at key points. Assessment is designed to be integral to the learning process and triangulates between learning outcomes, learning content and graduate attributes.

Pair project - 30%
Group project - 40%
Individual project I - 30%
Feedback Not entered
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Produce a protocol for a systematic review of literature
  2. Evidence a robust understanding of the concept of quantitative data synthesis in general and preform a meta-analysis of trial data using RevMan software
  3. Critically engage with the principles of trial design from a methodological and statistical standpoint
  4. Design and develop an outline protocol for a clinical trial from formulation of the research questions to analysis of the results
  5. Evaluate the contribution of qualitative methodologies to clinical trial study design, and critically appraise a mixed methods approach
Reading List
Additional Information
Graduate Attributes and Skills Within the work to be undertaken this course will provide course participants with the opportunity to develop or further develop key graduate attributes:
- In-depth knowledge of specialist discipline
- Develop new understanding by exercising critical judgement and challenging knowledge
- Be a self- directed and curious learner
- Solve problems effectively taking ethical, professional and environmental issues into account
- Use information responsibly in a range of contexts
- Collaborate with other, capitalising on their different thinking, experience and skills
- Communicate (written, oral, online) effectively, respectful of social and cultural diversity
- Application of numeracy
- Application of IT
KeywordsStudy Design,Clinical Trials,Cross-Over,Randomised,Placebo,Double-blinded
Course organiserProf Stuart Ralston
Tel: (0131 6)51 8743
Course secretaryMr David Stevens
Tel: 0131 242 6120
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