GCLP: Standard Operating Procedures & Analytical Plan

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    GCLP: Standard Operating Procedures and Analytical Plan is the fourth module of the Good Clinical Laboratory Practice (GCLP) course. The course is designed for all those wanting to gain an in-depth understanding of the principles of GCLP, how each principle is applied in a clinical laboratory and the impact implementation of these principles has on the laboratory and the clinical trial. It is highly recommended that you complete the following short courses and modules on the Global Health Training Centre before starting this module:

    1. ICH Good Clinical Practice
    2. Introduction to Good Clinical Laboratory Practice
    3. GCLP: Organisation & Personnel                                                                                                                                                                                                
    4. GCLP: Facilities, Equipment, Materials & Reagents

    Summary:

    This module provides a detailed analysis of GCLP guidance for the planning of the work to be conducted in the clinical trial laboratory and covers the documentation required to detail the work conducted in the analysis of participant samples, namely the analytical plan and standard operating procedures (SOPs). This module is based on the following guidelines and materials:

    Objectives:

    Upon successful completion of this course, you should be able to:

    • Explain the relationship between the clinical trial protocol, the analytical plan and standard operating procedures.
    • Establish high quality standard operating procedures which will ensure quality and integrity of the data produced in the laboratory
    • List and define the components of an SOP
    • Establish a system for SOP development
    • Understand the function and purpose of the analytical plan
    • Develop an analytical plan for a clinical trial in your laboratory

    Certification:
    A certificate is issued once a minimum of 80% is achieved in the final quiz section

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