Good Clinical Practice (GCP) is the international ethical, scientific, and practice standard to which all clinical research in humans is conducted. It is vital that everyone involved in clinical research is trained by appropriately experienced individuals to perform the specific tasks that they are asked to undertake.
This interactive and engaging course will provide you with everything you need to know about the new ICH GCP E6 (R3) regulations and guidance. We focus solely on the new regulation and why it has been updated.
Upon completion of this course, you will have a clear understanding of the end-to-end clinical drug testing process, including risk management and the considerations in the identification of critical to quality factors and quality by design.
This course can be booked on an individual or group basis. If you are interested in training for you or your organisation, please contact training@towermains.com.
✔ Understand the background, scope and applications of ICH E6 (R3)
✔ Consider the harmony between E6 (R3) and E8 (R1)
✔ Feel confident with the updated principles and how they impact trial design and conduct
✔ Apply updated guidance to roles and responsibilities of Ethics, Sponsors and Investigators
✔ Understand the heightened emphasis on risk proportionality and Quality by Design
This course would be beneficial for individuals who are:
✔ Individuals who are new to GCP and/or the new regulations
✔ Sponsors of clinical research who need to understand and update their GCP knowledge and requirements
✔ Sponsor Clinical Research Associates
✔ Clinical Investigators, Study Coordinators, Research Nurses, and other Investigator Site staff for example, pharmacy and labs.
1 day
The course is delivered to groups of up to 20 learners and broken down into four modules:
Topic 1:
- Introduction to clinical research
- The regulations for UK trials
Topic 2:
- Introduction to ICH GCP E6 (R3) and E8 (R1)
- Fitness for purpose
- The 11 Principles
Topic 3:
- Introduction to Annex 1
- Ethics
- Investigator
- Sponsor
- Data Governance – Investigator and Sponsor
Topic 4:
- Introduction to Annex 2
- Proportionality and Risk Management
- Structure
- Decentralised and pragmatic elements
- Investigator responsibilities
- Sponsor responsibilities
Topic 5:
- ICH E8 (R1)
- Essential documents and records
- Pressing the start button
This course consists of a mixture of presentations, and individual and interactive group exercises.
An electronic certificate of attendance will be issued to each delegate.
If you are interested in booking a future course, please contact Erin Bell to register your interest.
Testimonials
“I thought the course was informative and delivered by Fiona, someone who has first-hand experience of running/being involved in clinical trials. Her stories really brought the training material ‘to life’ and she answered all questions knowledgeably and honestly.”
“Easy to follow, very clear explained, entertaining, which is very helpful because the subject is sometimes heavy to digest.”
“I enjoyed the course immensely, the anecdotes made us laugh and helped make the content memorable. The experience and expertise of the presenters were clear and they promoted a friendly, open discussion where everyone was able to ask questions.”
“Fiona was very knowledgeable and engaging. They made the training informative and fun.”
“Extremely knowledgeable”