Fundamentals of Clinical Research (UK)

Registration is now open for the following courses:

• London, Sept. 21-22 — Register

Course Description
Brand new course reflecting current UK regulations. This course provides the core knowledge on which skills can be developed to enable clinical research professionals and research managers to fulfill their responsibilities effectively. There is a dual focus on the principles and regulatory frameworks which underpin clinical research work, together with an emphasis on the practical processes which support successful clinical trials. The course uses a range of teaching methods including activities which encourage participants to share their experiences and learn from one another. The two-day course will be repeated in different parts of the UK, to enable delegates to attend a local course.

Target Audience
Anyone involved in the clinical research processes who is seeking to acquire the core knowledge about clinical research regulations and trial management. This will include investigators, trial managers, research nurses, pharmacists, laboratory staff, R&D staff, data managers and ethics committee members. This two day course considers the perspective of those staff who are new to clinical research and helps to guide them through the challenges of Good Clinical Practice from its origins to its full UK implementation in The Medicines for Human Use (Clinical Trials) Regulations 2004. Some prior knowledge or experience would be helpful but is not essential since detailed course materials will be provided.

Learning Objectives
Upon successful completion of this course, participants should be able to:

• Discuss the main historical events which led to the increasing governance of clinical research and regulation of the development of medicinal products, devices and advanced therapy medicinal products (ATMPs)
• Define Good Clinical Practice and discuss its key principles
• Identify and describe the four phases of drug development
• Describe the steps required to ensure informed consent is obtained and maintained in compliance with current UK regulations
• Explain what an adverse experience is and describe the regulatory requirements for adverse experience reporting in the UK
• Explain the key differences in the development processes for medicinal products and medical devices
• Identify the roles and responsibilities of clinical research professionals in the overall process of conducting a clinical trial and how each professional contributes to that process
• Identify the main governance, regulations and guidance documents which govern the practice of clinical research in the UK
• Identify and describe at least 3 principles of a Quality Research Culture

Agenda
This course will proceed accoridng to the following agenda:

Day 1
0845-0900: Registration
0915-1030: Session 1 - Overview of Clinical Research
1030-1050: Break
1050-1220: Session 2 - Getting a Research Project on the Right Road
1220-1300: Lunch
1300-1430: Session 3 - Ethical Concerns and Human Subjects
1430-1500: Break
1500-1630: Session 4 - Research Governance
1630-1700: Questions, End of Day

Day 2
0845-0900: Registration
0900-1030: Session 5 - Oversight of Clinical Trials
1030-1050: Break
1050-1220: Session 6 - Generating Robust Data
1220-1300: Lunch
1300-1430: Session 7 - Safety Reporting
1430-1500: Break
1500-1630: Session 8 - Subject Recruitment: Meeting Enrollment Targets
1630-1700: Evaluations, Close of Session

Cost
The registration fee for the course is £425 per person for the two-day course. This covers the course training, course manual and materials and catering. It does not include overnight accommodation. If you require overnight accommodation you will need to make your own arrangements.