Postgraduate Course: Clinical Trials in Special Populations (MCLM11014)
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 | 10 |
| Home subject area | Molecular and Clinical Medicine |
Other subject area | None |
| Course website |
None |
Taught in Gaelic? | No |
| Course description | While many clinical trials may seek to recruit participants from a general population, others will require the study of special populations. The meaningful design of some clinical trials depends on an appropriate population being studied, such as those with a specific genetic background, with a rare disease or from a particular age group. The conduct of clinical trials is even more challenging when the population under study is a vulnerable one. These populations include children and young persons and adults who lack capacity, as well as groups whose communication may be compromised through language or cultural barriers. This module is designed to address these issues in detail, focusing on practical aspects of trial design and conduct as well as ethical and legal issues. |
Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
|
Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
| Additional Costs | None |
Course Delivery Information
|
| Delivery period: 2013/14 Semester 1, Not available to visiting students (SS1)
|
Learn enabled: Yes |
Quota: None |
Web Timetable |
Web Timetable |
| Course Start Date |
16/09/2013 |
| Breakdown of Learning and Teaching activities (Further Info) |
Total Hours:
100
(
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 2,
Directed Learning and Independent Learning Hours
0 )
|
| 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. Demonstrate the importance of selecting appropriate populations in trial design
2. Account for the legal and ethical implications of recruiting children and young people into clinical trials including differences throughout the devolved nations of the UK
3. Account for the legal and ethical implications of recruiting adults who lack capacity into clinical trials including differences throughout the devolved nations of the UK
4. Explain the importance and the complexities of recruiting participants from ethnic and racial minorities into clinical trials
5. Propose successful strategies for overcoming recruitment challenges in special populations. |
Assessment Information
Online participation: 25%
Individual project: 25%
Reflective portfolio: 30%
Case scenarios: 20% |
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 trials, legal, ethics, adults lacking capacity, children, rare diseases, cultural and commu |
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 |
|
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