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Good Clinical Laboratory Practice (GCLP) cover image

Good Clinical Laboratory Practice (GCLP)
Integrity Clinical Compliance

GCLP guidance identifies the systems required and procedures to be followed within an organisation.

Summary

Price
£159 inc VAT
Or £53.00/mo. for 3 months...
Study method
Online
Duration
4 hours · Self-paced
Access to content
2 years
Qualification
No formal qualification
Certificates
  • Certificate of completion - Free
Assessment details
  • End of course exam (included in price)
2 students purchased this course

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Overview

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 analyses 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 the analysis of Clinical Trial samples. It will ensure that all laboratory processes and results are GCLP compliant.

Certificates

Assessment details

End of course exam

Included in course price

Course media

Resources

Description

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, Organisations and Personnel

  • SOPs

  • Planning and Conduct of the Work

  • Reporting

  • Equipment and Computerised Systems

  • Quality Control

  • 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

  • Reporting Methods

  • Archiving

Chapter 4 - Summary

  • Course Summary

  • Course Exam

Who is this course for?

Anyone working in a laboratory taking part in clinical research trials.

Career path

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 the analysis of clinical trial samples. It will ensure that all laboratory processes and results are GCLP compliant.

Questions and answers

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Legal information

This course is advertised on Reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.
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