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DRPS : Course Catalogue : Deanery of Molecular, Genetic and Population Health Sciences : Molecular and Clinical Medicine

Postgraduate Course: Principles of Clinical Trial Management (MCLM11020)

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 Credits20 ECTS Credits10
SummaryThis 20-credit elective builds upon the Year 1 foundation of knowledge and skills around the design, delivery, management and reporting of clinical trials on the clinical trials programme for the exit award of PG Diploma or MSc.
Course description 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.
To some extent, we can draw on the principles of project management as applied to industrial production processes and the management of large construction projects. However, when it comes to the design and the management of an efficient and effective clinical trial that is completed on time and within budget we are limited to methods derived from 'custom and practice' and common sense.

Course participants will therefore evaluate different approaches to the various aspects of trial management by critically appraising the limited literature, but also by collaborative group work, drawing on knowledge of other group members to design processes for the conduct and oversight of an example trial. Equally important, course participants will be given authentic exercises in problem-solving to deal with the kind of difficulties that are commonly encountered during the course of a study. 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 and many more.

Course participants will gain a firm understanding and practical skills for the successful planning and management of clinical trials as introduced on earlier online lessons; current readings; interactive, independent activities; self tests; collaborative projects and discussions. The course will cover 6 main topic areas presented in the following Units over a period of 10 weeks.
- Unit 1 - Start-up and Project Planning of a New Trial
- Unit 2 - Recruitment and Retention
- Unit 3 - Data management and Monitoring
- Unit 4 - Funding and Budget Management
- Unit 5 - Oversight and Management of the Trial from Start to Finish
- Unit 6 - Marketing Clinical Trials
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Additional Costs 0
Course Delivery Information
Academic year 2018/19, 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) Assessment is undertaken throughout the course with each element structured to provide opportunities for formative feedback at key points. Assessment is designed to be integral to the learning process and triangulates between learning outcomes, learning content and graduate attributes.

Online discussion summary and reflections - 15%
Group project (including peer assessment) - 35%
Individual project - 50%
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
Additional Information
Graduate Attributes and Skills Within the work to be undertaken this course will provide course participants with the opportunity to develop or further develop key attributes:
- In-depth knowledge of specialist discipline
- Develop new understanding by exercising critical judgement and challenging knowledge
- Be a self-directed and curious learner
- Solve problems effectively taking ethical, professional and environmental issues into account
- Use information responsibly in a range of contexts
- Engage in reflective practice and self-development
- Collaborate with others, capitalising on their different thinking, experience and skills
- Communicate (written, oral, online) effectively, respectful of social and cultural diversity
- Application of numeracy
- Application of IT
Keywordsclinical trials,clinical trial management
Course organiserProf Stuart Ralston
Tel: (0131 6)51 8743
Course secretaryMrs Elspeth Currie
Tel: (0131 6)50 9242
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