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Good Clinical Laboratory Practice Course

This course focuses on Good Clinical Laboratory Practice and highlights important aspects of laboratory participation in clinical trials, including procedures for effective communication between investigators, monitors, and laboratory specialists. Key topics covered include defining GLP and GCLP, ISO laboratory standards and accreditation, and laboratory audits and selection criteria. The half-day course involves group discussions, case studies, and trainer input, and is aimed at clinical research associates, monitors, medical managers, project managers, clinical outsourcing managers, investigators, and laboratory specialists.

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Melnicof Dany
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0% found this document useful (0 votes)
11 views1 page

Good Clinical Laboratory Practice Course

This course focuses on Good Clinical Laboratory Practice and highlights important aspects of laboratory participation in clinical trials, including procedures for effective communication between investigators, monitors, and laboratory specialists. Key topics covered include defining GLP and GCLP, ISO laboratory standards and accreditation, and laboratory audits and selection criteria. The half-day course involves group discussions, case studies, and trainer input, and is aimed at clinical research associates, monitors, medical managers, project managers, clinical outsourcing managers, investigators, and laboratory specialists.

Uploaded by

Melnicof Dany
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd

EPR outline

Company: Training X
[Link]

Good Clinical Laboratory Practice

This course and the group discussions will highlight and define the most important aspects
of laboratory participation to a clinical trial, what aspects should be evaluated when
selecting a laboratory to work with, what procedures the participant laboratory should
have put in place and what are the best and efficient ways to communicate between
investigator, monitor and laboratory specialist during the study course, covering the pre-
analytical, analytical and post-analytical phases of the patient testing.

Key topics:

Define GLP and GCLP

Define ISO standards and accreditation in relation with clinical laboratory


work

Laboratory audit and selection

Methods

- Group discussions, case-studies, trainer input

Duration

- 1/2 day

Audience:

- CRAs, CRMs, Medical Managers and any other relevant R&D/Medical Department
staff
- Project Managers
- Clinical Outsourcing Managers
- Investigators
- Laboratory specialists

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