Postgraduate Course: Good Clinical Practice, Ethics and Regulatory Issues (MCLM11019)
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 | Modern clinical trials must be conducted in a highly regulated and legislated environment. This module is designed to familiarise candidates with the legal and ethical principles that form the basis of modern regulation. There will be a focus on UK legislation, but other relevant legal systems will be considered. The ethical basis of informed consent will be examined in detail. In addition, the workings of the Research Ethics Committee will be explored. |
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:
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. Discuss the basic ethical principles underpinning the conduct of clinical research and be familiar with the Declaration of Helsinki and the Belmont Report
2. Explain the principles underpinning valid informed consent
3. Outline the legal framework in the UK that governs the conduct of clinical research
4. Identify the Medicines for Human Use (Clinical Trials) Regulations, the Human Tissue Act, the Data Protection Act and the NHS Research Governance Framework
5. Apply the regulatory requirements for the conduct of Clinical Trial for Investigational Medicinal Products (CTIMPs) in the UK and Europe |
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, ethics, regulations, CTIMP (Clinical Trial for Investigational Medicinal Product) |
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 2013 The University of Edinburgh - 13 January 2014 4:42 am
|
University Homepage