Live Virtual Learning
DURATION OF COURSE
4 Modules / 6.5 hours
ASSESSMENT
At the end of each module, there will be a short question paper to evaluate and embed learning
CERTIFICATE
Electronic certificate of attendance will be issued to each delegate
We also include the current regulatory hot topics to keep you abreast of expectations.
Module 1 (1.5 hours)
What GCP is and when we use it; the Declaration of Helsinki; the language of GCP and the 13 Principles
Module 2 (2 hours)
Ethics; Investigator and Sponsor Responsibilities; Risk Management and Oversight
Module 3 (1.5 hours)
Clinical Trial Protocol; Investigator Brochure; Essential Documents and the Trial Master File
Module 4 (1.5 hours)
Revised or updated guidance and expectations; Key topics where the regulators have identified
issues; GDPR; The EU Clinical Trial Regulation; Data issues; lessons learned
This course is also suitable for those taking part in non-regulated clinical research as they must also comply with the 13 Principles of ICH GCP and they may use elements of the remainder of ICH GCP as a good practice standard.
Course Tutors
Tutors are comprised of
Fiona Waddell, Director
Course Dates
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