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

What is GCP and when does it apply? This introductory course provides an overview of the UK and EU GCP R2 Regulations and Guidance and explores the eight sections of GCP.

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

Individuals new to GCP, including those with a working knowledge of GCP including investigators and other site staff, monitors, CROs, Pharma personnel, QA, and sponsor study personnel who want to improve, maintain or update their existing knowledge base.

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

DATETIME (UCT)SESSIONPRICE
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