Good Clinical Laboratory Practice – Center for Tropical Medicine UGM

What is GCLP?

Good Clinical Laboratory Practice (GCLP) is a guideline for ensuring quality and consistency in handling laboratory samples for clinical trials. It bridges the gap between Good Clinical Practice (GCP), which lacks laboratory-specific standards, and Good Laboratory Practice (GLP), which does not cover human samples. Proposed by BARQA in 2003 and endorsed by WHO/TDR, GCLP is now a recognized standard, particularly in diagnostic evaluations for infectious diseases.

The Center for Tropical Medicine, UGM, has been a WHO/TDR Regional Training Center since 2010 and has successfully conducted GCLP regional courses since 2015 to build laboratory research capacity in Southeast Asia.

Modules

Following a brief introduction which provides an essay writers overview of the course, the training will be delivered through lectures, discussions, laboratory visit and problem analysis which focuses on a series of modules:

Personnel and Organization

Facilities, Equipment and Supplies

Sample Collection and Management

Standard Operational Procedures

Documents

Data Recording and Reporting

Method Validation

Quality Assurance and Quality Control

Laboratory Assessment

Facilitators

This course will be led by experienced professionals in the field:

Prof. dr. E. Elsa Herdiana, M.Kes, Ph.D
dr. Rina Susilowati, Ph.D
Dewi Kartikawati P., S.Si., M.Si., Ph.D
Dra. Dewajani Purnomosari, M.Si., Ph.D
Prof. Dr. Mae Sri Hartati, Apt
Jajah Fachiroh, S.P., M.Si., Ph.D
Prof. Dr. dr. Hera Nirwati, M.Kes
Dr. dr. Denny Agustiningsih, M.Kes
dr. Arta Farmawati, Ph.D
dr. E. Henny Herningtyas, M.Si., Ph.D

Requirements

Requirements
Target participants are those who are involved in research/clinical research with laboratory practices such as principal investigators, researchers, laboratory managers, etc.

To participate in this training, applicants must: