Postgraduate Course: Introduction to Clinical Trials (MCLM11002)
Course Outline
| School | School of Molecular, Genetic and Population Health Sciences |
College | College of Medicine and Veterinary Medicine |
| Course type | Online Distance Learning |
Availability | Not available to visiting students |
| Credit level (Normal year taken) | SCQF Level 11 (Postgraduate) |
Credits | 20 |
| Home subject area | Molecular and Clinical Medicine |
Other subject area | None |
| Course website |
None |
Taught in Gaelic? | No |
| Course description | This compulsory course forms the foundation for many of the subsequent courses on the MSc in Clinical Trials programme. A detailed understanding of the clinical trial process is essential for all members of the trial team.
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.
Successful participants will gain a firm understanding and practical knowledge of the key elements and principles of clinical trial design, delivery and analysis.
|
Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
|
Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
| Additional Costs | None |
Course Delivery Information
|
| Delivery period: 2014/15 Semester 1, Not available to visiting students (SS1)
|
Learn enabled: Yes |
Quota: None |
|
Web Timetable |
Web Timetable |
| Course Start Date |
15/09/2014 |
| Breakdown of 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 )
|
| Additional Notes |
|
| Breakdown of Assessment Methods (Further Info) |
Written Exam
0 %,
Coursework
100 %,
Practical Exam
0 %
|
| No Exam Information |
Learning Outcomes
On completion of this course, the student will be able to:
1. 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
2. Engage and contribute to current and emerging debate around clinical trial transparency, registration and disclosure
3. 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
4. Apply the principles of data analysis, dissemination of results and implementation of key findings
5. Critically appraise the methods by which procedural and epidemiological data underpin the development of clinical trials |
Assessment Information
5000 word essay - 50%
Discussion Board - 25%
MCQ - 25% |
Special Arrangements
| None |
Additional Information
| Academic description |
Not entered |
| Syllabus |
Not entered |
| Transferable skills |
Not entered |
| Reading list |
Not entered |
| Study Abroad |
Not entered |
| Study Pattern |
Not entered |
| Keywords | Clinical research, Trial management |
Contacts
| Course organiser | Miss Michelle Evans
Tel: 0131 537 3326
Email: michelle.evans@ed.ac.uk |
Course secretary | Mrs Danielle Marlow
Tel: 0131 537 3798
Email: Danielle.Wilson@ed.ac.uk |
|
© Copyright 2014 The University of Edinburgh - 29 August 2014 4:22 am
|
University Homepage