Postgraduate Course: Monitoring and Audit (MCLM11007)

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	The regulation of modern clinical trials requires that they adhere to accepted quality standards and that this adherence be demonstrable. All trials adhering to the principles of Good Clinical Practice must put in place a plan for monitoring as a means of quality assurance. In addition sponsoring institutions are expected to provide an audit function. External bodies, such as the MHRA in the UK and the FDA in the USA, also have inspection programmes in place, which further supplement these quality systems. This module is designed to familiarise candidates with the principles of monitoring, audit and inspection and to examine different approaches to these tasks.
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 2
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: Distinguish between monitoring, audit and inspection of clinical trials Assess the role of the clinical trials monitor Design a monitoring strategy for a clinical trial Prepare for a statutory inspection from the UK MHRA