Postgraduate Course: Good Clinical Practice, Ethics and Regulatory Issues (MCLM11019)
|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
|Summary||This compulsory 20-credit course forms the foundation for many of the subsequent courses on the Clinical Trials programme. A detailed understanding of the regulatory framework within which clinical trials are run is essential for all members of the trial team.
Modern clinical trials are now conducted within a highly regulated legal and regulatory framework. This course will introduce course participants to Good Clinical Practice (GCP), an internationally recognized set of safety and quality standards that form the basis for the conduct of most modern clinical trials. We will review the history of GCP development and evaluate its current place in modern clinical research.
GCP was developed chiefly to guide the pharmaceutical industry in the conduct of clinical trials of new drug products to obtain market authorization for them. However, many clinical trials are not undertaken by the pharmaceutical industry, and evaluate a great variety of non-drug interventions to improve health, ranging across surgery, medical devices (e.g. pacemakers, stents), different types of patient therapies (e.g. physiotherapy) and the organization of care (e.g. stroke units).
There is a great variation in the legal and regulatory framework for trials around the world, and hence considerable variation in the interpretation and implementation of GCP. This course will therefore focus on key principles, and use authentic examples to critically explore and enable participants to draw their own conclusions of how GCP might be applied in practice in a range of clinical trials in their own country.
This course will focus on:
- Informed consent
- Monitoring (together with quality improvement)
- Safety reporting
- Defining roles and responsibilities within a trial
Participants will debate and discuss how the method to obtain informed consent (and to document that process) might vary in order to match and be proportionate to the particular clinical setting.
The conduct of trials involves working with teams of people, so participants will need to develop an understanding of how roles and responsibilities are defined and delegated within a trial. Participants will also need to develop an understanding of the key elements of risk assessment. Risk assessment is the first step in the design of the processes both to monitor the conduct of a trial and to assess the safety and well-being of its patients. This in turn will require critical appraisal of the key elements of data quality in a trial and the methods to assess that.
Throughout the course, participants will need to take a thoughtful and critical approach to the elements of the trial that are essential in a particular clinical setting to achieve the goal of high quality data. Participants will come to learn through how the application of the principles of GCP can improve a trial, while also appreciating that the regulatory framework allows for flexibility in the details of how GCP is interpreted and implemented in a specific study.
Course participants will gain a firm understanding and international knowledge of the regulatory framework and conduct guidelines that apply to the conduct of clinical trials as presented in the following 4 units over the course of 10 weeks:
- Unit 1 - The History of and Development of GCP
- Unit 2 - Informed Consent
- Unit 3 - Approaches to Monitoring
- Uni 4 - Safety Reporting
Entry Requirements (not applicable to Visiting Students)
||Other requirements|| None
Course Delivery Information
|Academic year 2018/19, Not available to visiting students (SS1)
|Learning and Teaching activities (Further Info)
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
|Assessment (Further Info)
|Additional Information (Assessment)
||Assessment is undertaken throughout the course with each element structured to provide opportunities for formative feedback at key point. Assessment is designed to be integral to the learning process and triangulates between learning outcomes, learning content and graduate attributes.
Assessment components and weighting:
Online participation: 15%
Group project (including peer assessment): 35%
Individual project I: 50%
|No Exam Information
On completion of this course, the student will be able to:
- Critically assess and conceptualise the practicalities of applying GCP in a given trial
- Appraise the process of informed consent for clinical trials in different settings and defend the approaches applied in specific patient populations
- Recommend different approaches to monitor and improve the quality of the conduct of a trial and its data and evaluate their relative merits
- Rationalise the use of the key principles in safety reporting and monitoring of clinical trials that can assure the safety of participants
- Exercise appropriate judgment on the regulatory and ethical legal frameworks that govern clinical trials in the UK, the EU and worldwide
|Graduate Attributes and Skills
||Within the work to be undertaken this course will provide participants with the opportunity to develop or further develop key graduate attributes:
- In-depth knowledge of specialist discipline
- Develop new understanding by exercising critical judgement and challenging knowledge
- Be a self-directed 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 (oral, written, online) effectively, respectful of social and cultural diversity
- Application of numeracy
- Application of IT
|Keywords||Clinical trials,ethics,regulations,CTIMP (Clinical Trial for Investigational Medicinal Product)
|Course organiser||Miss Michelle Evans
Tel: (0131 6)51 5440.
|Course secretary||Mrs Elspeth Currie
Tel: (0131 6)50 9242