Postgraduate Course: Introduction to Clinical Trials (MCLM11002)
Course Outline
| School | Deanery of Molecular, Genetic and Population Health Sciences |
College | College of Medicine and Veterinary Medicine |
| Credit level (Normal year taken) | SCQF Level 11 (Postgraduate) |
| Course type | Online Distance Learning |
Availability | Not available to visiting students |
| SCQF Credits | 20 |
ECTS Credits | 10 |
| Summary | This compulsory 20-credit course forms the foundation for many of the subsequent courses on the Clinical Trials programme. A detailed understanding of the clinical trial process is essential for all members of the trial team. Course participants will gain a firm understanding and practical knowledge of the key elements and principles of clinical trial design, delivery and analysis. |
| Course description |
Course participants will learn how research hypotheses are formulated and tested and will follow the process from initial concept through to the development of a clinical trial protocol and then on to the execution of the study and ultimately the dissemination of research findings.
The focus of the course will be threefold:
- The design of clinical trials
- The principles of their analysis
- The interpretation of their findings
Course participants will learn about different design elements of clinical trials. The concepts of randomisation, blinding, bias, internal and external validity, the definition of study endpoints and the choice of appropriate outcome measures will be thoroughly explored as will the need for the selection of appropriate populations and power calculations.
Protocol design will be examined in detail and use will be made of clinical trial case studies including those testing both pharmacologic and non-pharmacologic interventions.
The course is presented in the following 4 units over a 10-week period:
- Unit 1 - Introduction to Clinical Trials
- Unit 2 - The Trial Design
- Unit 3 - Statistics and Trial Design
- Unit 4 - Professional misconduct of Clinical Trials
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Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
|
Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
Course Delivery Information
|
| Academic year 2017/18, Not available to visiting students (SS1)
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Quota: None |
| Course Start |
Semester 1 |
| Course Start Date |
18/09/2017 |
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 through 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.
Online participation - 15%
Group project - 30%
Individual project I - 20%
Individual project II - 35% |
| Feedback |
Not entered |
| No Exam Information |
Learning Outcomes
On completion of this course, the student will be able to:
- Critically assess the factors that contribute to suitable trial design for a research question including selection of appropriate endpoints, choice of sample size, data analysis, presentation of results and implementation in routine clinical practice
- Engage and contribute to current and emerging debate around clinical trial transparency, registration and disclosure
- Contribute to the design, authoring and evaluation of a clinical trials protocol; critically discuss the challenges of clinical trial delivery including study design, trial set up, recruitment, follow up and data collection
- Apply the principles of data analysis, dissemination of results and implementation of key findings
- Critically appraise the methods by which procedural and epidemiological data underpin the development of clinical trials
|
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
- Engage in reflective practice and self-development
- Collaborate with others, 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 |
| Keywords | Clinical research,Trial management |
Contacts
| Course organiser | Miss Michelle Evans
Tel: 0131 537 3326
Email: |
Course secretary | Mrs Danielle Marlow
Tel: 0131 537 3798
Email: |
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