THE UNIVERSITY of EDINBURGH

DEGREE REGULATIONS & PROGRAMMES OF STUDY 2014/2015
Archive for reference only
THIS PAGE IS OUT OF DATE

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

Postgraduate Course: Principles of Clinical Trial Management (MCLM11020)

Course Outline
SchoolSchool 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 Credits20 ECTS Credits10
SummaryThis module will cover six aspects of trial management: start-up and project planning of a new trial; recruitment and retention; data management; funding and budget management; marketing; overall management and oversight. Although much has been written about the theory and principles of the design of clinical trials, much less has been written about the core principles of trial management and their practical application. There is surprisingly little empirical evidence on the relative costs and effectiveness of different approaches to the management of clinical trials.
The principles involved in the design of an efficient and effective clinical trial that is completed on time and within budget have much in common with industrial production processes and the management of large construction projects. Students will therefore evaluate different approaches to the different aspects of trial management by critically appraising the available literature.
The course work will involve collaborative projects, drawing on knowledge from the literature, to design efficient processes for the conduct and oversight of an example trial. Equally importantly, students will be given realistic exercises in problem-solving in small collaborative groups to deal with the kind of difficulties that are commonly encountered during the course of a study. These will include problems such as inadequate recruitment, new safety concerns, frequent protocol violations, and unexpected advice from the Data Monitoring Committee to suspend recruitment.
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 2014/15, Available to all students (SV1) Quota:  None
Course Start Semester 1
Timetable Timetable
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 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) Online participation - 20 %
Written individual project 1 - 15%
Group project and reflection - 35%
Written individual project 2 - 15%
Feedback Not entered
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Design a project management plan (Gantt chart)
  2. Develop trial management and monitoring systems
  3. Create a trial marketing plan
  4. Critically appraise trial funding and resource allocation methods for trials of different types of interventions
  5. Evaluate strategies for recruitment and retention
Reading List
None
Additional Information
Graduate Attributes and Skills Not entered
Keywordsclinical trials, clinical trial management
Contacts
Course organiserProf Stuart Ralston
Tel: 72 791 31108
Email: Stuart.Ralston@ed.ac.uk
Course secretaryMiss Michelle Evans
Tel: 0131 537 3326
Email: michelle.evans@ed.ac.uk
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 2014 The University of Edinburgh - 12 January 2015 4:23 am