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

Postgraduate Course: Ethical and Regulatory Considerations in Clinical Trials (MCLM11078)

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 AvailabilityAvailable to all students
SCQF Credits20 ECTS Credits10
SummaryThis course will equip students with the ability to implement a clinical trial that complies with the relevant legislative and governance frameworks.
Course description Clinical trials must be conducted in a highly regulated environment, designed to protect the rights, safety and well-being of participants and the credibility of trial data. This course will explore the fundamental ethical principles that underpin clinical research guidelines and shape the regulatory landscape globally.

Students will be introduced to key ethical and regulatory frameworks in place today, consider the drivers for their development and evaluate their impact on RCTs. There will be a focus on Good Clinical Practice (GCP), an international safety and quality standard, which will allow students to develop an understanding of the main objectives of GCP and how it can be applied in an effective and risk proportionate manner.

Research governance structures will be considered, including external review by regulatory authorities and ethics committees, as well as the internal mechanisms sponsors use to maintain oversight of clinical trials.

Students will examine the ethical basis of informed consent, with critical exploration of how consent can be obtained in a variety of settings and patient populations. They will further explore how trial participants are safeguarded through the application of safety reporting procedures, and the importance of data integrity in supporting good decision making for future patient care.

Throughout the course students will be challenged to address difficult ethical issues in RCTs, apply their knowledge and critical thinking to draw their own conclusions on the application of ethical and regulatory frameworks, and discuss and debate their position with their peers through online participation.
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Information for Visiting Students
High Demand Course? Yes
Course Delivery Information
Academic year 2023/24, Available to all students (SV1) Quota:  None
Course Start Flexible
Course Start Date 05/08/2023
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 200 ( Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 196 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) 100% course work
Feedback Not entered
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Demonstrate a critical understanding of how to apply ethical and regulatory frameworks in a variety of settings.
  2. Evaluate and implement a clinical trial protocol from an ethical and regulatory perspective.
  3. Appraise the process of informed consent for clinical trials in different settings and defend the approaches applied in specific patient populations.
Reading List
Please refer to the programme handbook.
Additional Information
Graduate Attributes and Skills Research and enquiry: Problem solving, critical thinking, handling complexity and ambiguity, knowledge integration and application.
Personal and intellectual autonomy: Ethical and social responsibility, decision-making, independent learning and development.
Communication: cross cultural communication, written communications, verbal communication and presentation, interpersonal skills
Personal Effectiveness: Planning, organising and time management, professional and situational awareness, assertiveness and confidence.
KeywordsEthics,GCP,RCTs,Regulation,Clinical Trial,Legislation,Governance,Informed Consent
Course organiserMr James Gibson
Course secretaryMs Rebecca Sewell
Tel: (0131 6)51 7112
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