A. Course Description:
Good Clinical Laboratory Practice (GCLP) applies principles established under Organization for Economic Cooperation and Development Good Laboratory Practices (GLP) that cover the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. If a laboratory does not have good clinical laboratory practice, the reliability, quality, consistency, and integrity of data generated might be questionable which is crucial to the outcome of any clinical trial. This course will equip the participants with the principles relevant to the analysis of samples from a clinical trial and ensure that these guidelines are carried out in a way that is compliant with the ICH Good Clinical Practices.
B. Expected Output
Application of learning through assessment of their home laboratories using the provided checklist.
C. Course Length:
The training will be conducted for two days:
First day: 07:30 a.m. – 05:00 p.m.
Second day: 08:00 a.m. – 05:00 p.m.
D. Intended Audience:
The training is intended for professionals who currently manage or work in a laboratory, having at least one (1) year of exposure in a clinical laboratory setting, especially those involved in clinical trials.
E. Language of the Course:
The course will be conducted using the English language.
F. Course Requirement:
There is no specific requirement for the course as long as the participants qualify under the description for the intended audience.
G. Training Methodology:
This course shall be taught using the following training methodologies and techniques:
1. Classroom training
• Powerpoint presentation
2. Interactive training
• Small Group Discussion
• Case studies
• Q & A Session
H. Training Content:
Module 1: Overview of Good Clinical Laboratory Practices
Module 2: Personnel Organization
Module 3: Facilities, Equipment, Materials, and Reagents
Module 4: Specimen Management
Module 5: Good Documentation Practices
Module 6: Standard Operating Procedures
Module 7: Quality Systems
I. Training Evaluation
J. Certificates of Training:
Certificate of participation will be awarded to participants who have completed the two-day training.
K. Reading Materials:
a. Good Clinical Laboratory Practice (World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases, 2009)
For more information, please contact RITM RTC at email@example.com.