EPR outline
Company: Training X
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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