Postgraduate Course: Clinical Trials in Special Populations (MCLM11014)

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	10	ECTS Credits	5
Summary	While many clinical trials may seek to recruit participants from a general population, others will require the study of special populations. The meaningful design of some clinical trials depends on an appropriate population being studied, such as those with a specific genetic background, with a rare disease or from a particular age group. The conduct of clinical trials is even more challenging when the population under study is a vulnerable one. These populations include children and young persons and adults who lack capacity, as well as groups whose communication may be compromised through language or cultural barriers. This module is designed to address these issues in detail, focusing on practical aspects of trial design and conduct as well as ethical and legal issues.
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 1
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: Demonstrate the importance of selecting appropriate populations in trial design Account for the legal and ethical implications of recruiting children and young people into clinical trials including differences throughout the devolved nations of the UK Account for the legal and ethical implications of recruiting adults who lack capacity into clinical trials including differences throughout the devolved nations of the UK Explain the importance and the complexities of recruiting participants from ethnic and racial minorities into clinical trials Propose successful strategies for overcoming recruitment challenges in special populations.