THE UNIVERSITY of EDINBURGH

DEGREE REGULATIONS & PROGRAMMES OF STUDY 2017/2018

University Homepage
DRPS Homepage
DRPS Search
DRPS Contact
DRPS : Course Catalogue : Deanery of Molecular, Genetic and Population Health Sciences : Molecular and Clinical Medicine

Postgraduate Course: Monitoring and Audit (MCLM11007)

Course Outline
SchoolDeanery of Molecular, Genetic and Population Health Sciences CollegeCollege of Medicine and Veterinary Medicine
Credit level (Normal year taken)SCQF Level 11 (Postgraduate)
Course typeOnline Distance Learning AvailabilityNot available to visiting students
SCQF Credits10 ECTS Credits5
SummaryThe 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 2017/18, 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:
  1. Distinguish between monitoring, audit and inspection of clinical trials
  2. Assess the role of the clinical trials monitor
  3. Design a monitoring strategy for a clinical trial
  4. Prepare for a statutory inspection from the UK MHRA
Reading List
None
Additional Information
Graduate Attributes and Skills Not entered
KeywordsClinical trials, quality assurance, GCP, MHRA, inspections, sponsors
Contacts
Course organiserMiss Michelle Evans
Tel: 0131 537 3326
Email:
Course secretaryMrs Danielle Marlow
Tel: 0131 537 3798
Email:
Navigation
Help & Information
Home
Introduction
Glossary
Search DPTs and Courses
Regulations
Regulations
Degree Programmes
Introduction
Browse DPTs
Courses
Introduction
Humanities and Social Science
Science and Engineering
Medicine and Veterinary Medicine
Other Information
Combined Course Timetable
Prospectuses
Important Information
 
© Copyright 2017 The University of Edinburgh - 6 February 2017 8:42 pm