Postgraduate Course: Principles of Clinical Trial Management (MCLM11020)
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 | This 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.
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Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
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Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
| Additional Costs | None |
Course Delivery Information
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| Delivery period: 2014/15 Semester 1, Available to all students (SV1)
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Learn enabled: Yes |
Quota: None |
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Web Timetable |
Web Timetable |
| Course Start Date |
15/09/2014 |
| 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 )
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| Additional Notes |
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| Breakdown of Assessment Methods (Further Info) |
Written Exam
0 %,
Coursework
100 %,
Practical Exam
0 %
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| 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 |
Assessment Information
Online participation - 20 %
Written individual project 1 - 15%
Group project and reflection - 35%
Written individual project 2 - 15% |
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 |
Unit 1: Start-up and project planning of a new trial
Unit 2: Oversight and management of the trial from start to finish
Unit 3: Recruitment and Retention
Unit 4: Data Management and Monitoring
Unit 5: Funding and Budget Management
Unit 6: Marketing Clinical Trials |
| Keywords | clinical trials, clinical trial management |
Contacts
| Course organiser | Prof Stuart Ralston
Tel: 72 791 31108
Email: Stuart.Ralston@ed.ac.uk |
Course secretary | Miss Michelle Evans
Tel: 0131 537 3326
Email: michelle.evans@ed.ac.uk |
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