Postgraduate Course: Monitoring and Audit (MCLM11007)
This course will be closed from 13 January 2017
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 | 10 |
ECTS Credits | 5 |
| Summary | The regulation of modern clinical trials requires that they adhere to accepted quality standards and that this adherence be demonstrable. All trials adhering to the principles of Good Clinical Practice must put in place a plan for monitoring as a means of quality assurance. In addition sponsoring institutions are expected to provide an audit function. External bodies, such as the MHRA in the UK and the FDA in the USA, also have inspection programmes in place, which further supplement these quality systems. This module is designed to familiarise candidates with the principles of monitoring, audit and inspection and to examine different approaches to these tasks. |
| Course description |
Not entered
|
Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
|
Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
Course Delivery Information
|
| Academic year 2016/17, Not available to visiting students (SS1)
|
Quota: None |
| Course Start |
Semester 2 |
Timetable |
Timetable |
| 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 )
|
| Assessment (Further Info) |
Written Exam
0 %,
Coursework
100 %,
Practical Exam
0 %
|
| Additional Information (Assessment) |
Online participation: 25%
Individual project: 25%
Reflective portfolio: 30%
Case scenarios: 20% |
| Feedback |
Not entered |
| No Exam Information |
Learning Outcomes
On completion of this course, the student will be able to:
- Distinguish between monitoring, audit and inspection of clinical trials
- Assess the role of the clinical trials monitor
- Design a monitoring strategy for a clinical trial
- Prepare for a statutory inspection from the UK MHRA
|
Additional Information
| Graduate Attributes and Skills |
Not entered |
| Keywords | Clinical trials, quality assurance, GCP, MHRA, inspections, sponsors |
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 2016 The University of Edinburgh - 3 February 2017 4:45 am
|
University Homepage