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 thats 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 users previous knowledge and as the course contains lots of links to more information, it will also depend how many the user choose to access.
At the end of the course the user can download and print their own certificate as a record of their course completion.
Chapter 1 - What is GCP
- The historical background to GCP
- Why should we have GCP
- The principles of GCP
- Key things to remember
Chapter 2 - Independent Ethics Committees
- IEC and Competent Authorities
- Review of IEC/CA responsibilities
Chapter 3 - Investigator Responsibilities
Chapter 4 - Informed Consent Introduction
- Features of an Informed Consent Form
- Informed Consent Quiz
Chapter 5 - Sponsor Responsibilities
- What is a sponsor and what do they do?
- Sponsor Responsibilities
Chapter 6 - Monitor Responsibilities
- Why Monitor a trial
- Verifying subject data
Chapter 7 - Safety and Adverse Event Reporting
- Patient safety
- The reasons for and elements of safety reporting
- What to do when AE/SAE or SUSAR occur
- Safety and AE reporting quiz
Chapter 8 - Clinical Trial Protocol
- Protocol Structure and Content
- Investigator Brochure
Chapter 9 - Recording and reporting
- Types of data knowledge check
- Reporting of ADR and SUSAR
Chapter 10 - Essential Documents
- Documentation before, during and after a clinical trial
- General rules for archiving essential documents
Fiona Duthie, PhD
Ewelina Testoni, PhD
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0161 633 4594
82 Lane Head Farm, Lane Head Road, Lees, Oldham, OL45RT