Good Clinical Laboratory Practice
A professionally developed, interactive and engaging online training course.
Delivering unique, exciting and interactive e-learning technology courses.
ABOUT THE COURSE
Good Clinical Laboratory Practice (GCLP) was first drafted and published in 2003. Then, in 2006 the World Health Organisation (WHO) published GCLP guidance on its website as the standard for laboratories undertaking samples from clinical trials.
GCLP guidance identifies the systems required and procedures to be followed within an organisation which conducts analysis of samples from clinical trials in compliance with the requirements of Good Clinical Practice (GCP).
This interactive and engaging GCLP course provides sponsors, laboratory management, project managers, CRAs and quality assurance personnel with an understanding of the framework for a quality system in analysis of clinical trial samples. It will ensure that all laboratory processes and results are GCLP compliant.
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.
Introduction to GLP
What is GCLP?
How is GCLP different to GCP and GLP?
How did the GCLP guidelines become established?
Who needs GCLP?
Chapter 1 - General Provisions
Common definitions referred to in GCLP
Raw data and its role in GCLP
Introduction to the principles of GCLP
Chapter 2 - Principles of GCLP
Facilities, organisation and personnel
Planning and conduct of the work
Equipment and computerised systems
Storage and retention of records
Confidentiality, blinding and participant safety
Chapter 3 - Implementation of GCLP
Clinical trial protocol
Writing an analytical plan
Sample collection, transportation, reception and analysis
Chapter 4 - Summary
Reflection and review
Stefan Smet, Writingale
Ewelina Testoni, PhD
Fiona Duthie, PhD
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