Postgraduate Course: Principles of Clinical Trial Management (MCLM11020)
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 | 20 |
ECTS Credits | 10 |
| Summary | This course will equip students with the knowledge and skills to effectively support and manage a clinical trial. |
| Course description |
This course will draw on the principles of project management and project teams as applied to industrial processes and the management of large multidisciplinary projects. It will cover different elements of project and trial management each week ranging from how to set up and manage a project plan and project team, clinical study project initiation, management and close out procedures as well as quality control activities and budget management in this setting.
Students will work as a study team to design and describe the management of an efficient and effective clinical trial that is completed on time and within budget. Students will evaluate different approaches to the various aspects of trial management by critically appraising the literature, and by collaborative group work, drawing on knowledge of other group members to design processes for the conduct and oversight of an example trial. Students will be given authentic exercises in problem-solving, risk management and impact analysis to deal with the kind of difficulties that are commonly encountered during the course of a trial. These may include problems such as adequate recruitment, new safety concerns, frequent protocol violations, and unexpected advice from the Data Monitoring Committee (DMC) to suspend recruitment.
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Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
|
Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
| Additional Costs | 0 |
Course Delivery Information
|
| Academic year 2022/23, Not available to visiting students (SS1)
|
Quota: None |
| Course Start |
Flexible |
| Course Start Date |
08/08/2022 |
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 %
|
| Feedback |
Not entered |
| No Exam Information |
Learning Outcomes
On completion of this course, the student will be able to:
- Demonstrate a critical understanding of trial management structures and processes
- Develop and adapt strategies for trial participant recruitment and retention
- Apply project management skills to support the planning and conduct of a clinical trial
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Reading List
| Please refer to the programme handbook |
Additional Information
| Graduate Attributes and Skills |
Personal Effectiveness: Leadership, planning organising and time management, team working, change management, flexibility, professional awareness
Research and enquiry: Problem solving, critical thinking, handling complexity and ambiguity, knowledge integration and application.
Communication: cross cultural communication, written communications, verbal communication and presentation, interpersonal skills, social media, influencing and negotiation skills
Personal and intellectual autonomy: Decision making, self-awareness and reflection, independent learning and development
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| Keywords | Trial Management,Clinical Research,Randomised Clinical Trials,Leadership,Project Management |
Contacts
| Course organiser | Ms Judith Syson
Tel:
Email: judith.syson@ed.ac.uk |
Course secretary | Ms Rebecca Sewell
Tel: (0131 6)51 7112
Email: Rebecca.Sewell@ed.ac.uk |
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