Good clinical practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance of data and the reported results are credible and accurate. In addition, the rights, integrity and confidentiality of trial subjects are protected.
By looking at the demand of the need of GCP in order to carry out any research involving human subjects, the Continuing Professional Development (CPD) committee of Faculty of Pharmacy, AIMST University, jointly organized its first GCP workshop with the Clinical Research Centre (CRC), Hospital Sultan Abdul Halim, Sungai Petani at AIMST University.
Among the total of 60 participants, 44 were from AIMST University and 16 from Ministry of Health personnel. This event received positive feedbacks from all the participants. Participants learnt how to ensure that drug-related trials in Malaysia are conducted in accordance with international ethical and scientific standards.
Furthermore, the participants were also exposed in details to the quality processes required in the conduct of clinical trials and ensure that the human subjects participating in the trial are well protected and thus conducted studies are based on good science background and are well-designed.
The rules and regulations pertaining to conducting a clinical trial in Malaysia were shared with all the participants on the last day of the event. The workshop ended with a one hour written exam. We hope that this will increase the awareness of GCP amongst the researchers and promote meaningful clinical research in Malaysia. This shall pave the way for our researchers to achieve excellence in clinical research.
Contributed by: Mr. Ng Yen Ping, AIMST University, Malaysia.
Source: AIMST E-Bulletin Volume II Issue III (October 2016)