Postgraduate Course: Clinical Trial Management (MCLM11017)
This course will be closed from 31 July 2014
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 | The successful delivery of any clinical trial depends in large part on successful management. Whether a trial is conducted by an individual or a team the principles of good clinical practice and management should be applied. These principles will ensure adherence to projected timelines and budgets as well as the ability to respond to unforeseen circumstances and changes in the protocol, while ensuring participant safety and data quality. This module is designed to equip candidates with the necessary theoretical knowledge to implement a successful project management plan for a clinical trial. In addition, the module will explore the practical applications of these principles with particular reference to team management, site management, document management, and IMP management. In addition, candidates will develop a successful strategy for the overall conduct of a trial from inception to publication. |
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 2, Not available to visiting students (SS1)
|
Learn enabled: Yes |
Quota: None |
|
Web Timetable |
Web Timetable |
| Course Start Date |
13/01/2014 |
| 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. Apply the theoretical principles underlying project management to the context of a clinical trial
2. Discuss the critical importance of planning and critical performance review
3. Recognise the role of responsiveness in any successful project
4. Apply successful project management strategies to case studies |
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, GCP, team management, site management, timelines, budgets, protocols and amendments |
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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