A professionally developed, interactive and engaging online training course.
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ABOUT THE COURSE
This is a professionally developed, interactive and engaging online Good Clinical Practice training course which incorporates the ICH E6 R2 update implemented in June 2017.
It is suitable for anyone carrying out or involved in clinical research and will provide individuals with official certification in GCP that is widely accepted by all Sponsors and CROs.
It was created by our subject matter expert who has worked in clinical research for 30 years and has delivered training in GCP all around the world. The course meets the required standards for ICH GCP Investigator site personnel training identified by Transcelerate Biopharma inc. (this can be checked on their website).
Finally, an online learning platform that’s fun, engaging and can be taken on any device, anywhere, anytime.
WlLL THE COURSE TAKE?
This course takes approx. 2-3 hrs to complete. This time will vary depending on the user’s previous knowledge, and as the course contains lots of links to more information, it will also depend how many the user chooses to access.
At the end of the course the user can download and print their own certificate as a record of their course completion.
£99 (inc VAT)
This is the new updated course of GCP for 2020 to remain current and has improved knowledge checks and interaction to create a more engaging experience for our users.
You will also gain free access to our online course – “Managing Clinical Trials During COVID-19“
Module 1 – Introduction to ICH GCP/Ethics
Chapter 1 – What is ICH GCP
- What is Good Clinical Practice (GCP)
- The Historical background to GCP
- The Principles of ICH GCP
Chapter 2 – Key Legislation and Regulations
- Regulatory and Advisory Bodies
- Key Legislation
Chapter 3 – Ethics and Safeguarding
- What is an Ethics Committee and why do we need it?
Module 2 - Key people and their responsibilities
Chapter 4 – Investigator
- Who is an Investigator?
- Investigator responsibilities
- Investigator non-compliance
- Investigator scenario
Chapter 5 – Sponsor
- Who is a Sponsor?
- Sponsor responsibilities
- Quality Management, Risk, QA, QC
- Trial Management, data handling and record keeping
- Investigator and Monitor selection
- Sponsor scenario
Chapter 6 – Monitor
- What is Monitoring and why is it necessary?
- Monitoring approaches
- Monitoring visits and reporting
- Monitoring scenario
Module 3 - How is compliance with GCP ensured
Chapter 7 – Patient Safety
- What is Patient Safety?
- Who is responsible for Patient Safety?
- Safety Reporting
Chapter 8 – Informed Consent
- What is Informed Consent?
- How is Informed Consent acquired?
Chapter 9 – Investigational Product (IP)
- What is IP
- IP responsibilities
Chapter 10 – Protocol and Investigator Brochure
- Clinical Trial Protocol
- Investigator Brochure
Chapter 11 – Essential Documents
- Essential Documents
- Electronic records and Trial Master File (TMF)
Chapter 12 – Summary
- GCP exam
- Accessing your certificate
Fiona Duthie, PhD
Ewelina Testoni, PhD
Stefan Smet, Writingale
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0161 628 9626
82 Lane Head Farm, Lane Head Road, Lees, Oldham, OL45RT