JOHOR BAHRU, May 7 – From May 5 to 7, 2025, Universiti Teknologi Malaysia (UTM), in collaboration with the Institut Jantung Negara (IJN) and the UTM Cardiovascular Engineering Centre (CEC), successfully conducted the Professional Course on Good Clinical Practice (GCP) 2025. This three-day program took place at the Seminar Room of the Media and Games Innovation Centre of Excellence (MaGICX) in UTM Johor Bahru, gathering participants from the clinical and research communities nationwide.
The course was designed to equip participants with in-depth knowledge of Good Clinical Practice (GCP), an internationally recognised ethical and scientific standard for the design, conduct, documentation, and reporting of clinical trials involving human participants. The course emphasised the importance of participant safety and data integrity as top priorities in research.
Throughout the program, participants engaged in comprehensive sessions covering key aspects of clinical trial conduct, including regulatory frameworks, informed consent procedures, the functions of ethics committees, and quality assurance practices. Interactive discussions and case-based learning enabled attendees to address real-world challenges and effectively apply Good Clinical Practice (GCP) principles. The course was open to professionals involved in or entering the field of clinical research, including researchers, study coordinators, healthcare practitioners, and academic staff. Its objective was to strengthen research quality and reinforce ethical practices in human subject research.
Additionally, this course is mandatory for participants seeking GCP certification, which is essential for conducting clinical research.
To deliver the course content and share valuable insights, five esteemed speakers were invited from various institutions: Dr. Tay Ju Fan from the National Institute of Health (NIH), Dr. Azizan Sharif from Hospital Sultanah Aminah (HSA), Goh Tse Seng from CSI Clinical Research Sdn. Bhd., Zakiah Bakar Ali from the National Pharmaceutical Regulatory Agency (NPRA), and Dr. Ahmad Zahran Md. Khudzari from UTM.
A total of 12 participants completed the entire course and took the GCP examination. The open-book GCP examination lasted for one hour. It included a total of 40 MCQ questions, supervised by Syarifah Syamila Tuan Zakaria and Nur Athirah Mohd Azizi from NIH, with assistance from Dr. Hau Yuan Wen and Hilmi Abdul Rahman.
Participants expressed positive feedback, highlighting how the course clarified complex regulatory requirements and boosted their confidence in managing clinical trials. One participant remarked, “This course has deepened my understanding of legal and ethical responsibilities in research. It helped resolve many of my doubts, especially regarding documentation and participant consent.”
This initiative highlights UTM’s proactive role in enhancing Malaysia’s clinical research ecosystem, with the IJN-UTM Cardiovascular Engineering Centre playing a key role in promoting high standards of research ethics and professionalism. By hosting this GCP training, UTM reaffirms its commitment to advancing responsible and ethical research practices across the nation.
Stay informed about upcoming programs by the IJN-UTM Cardiovascular Engineering Centre via UTM’s official communication platforms.