[Padang, Indonesia] — RSUP Dr. M. Djamil Padang launches Clinical Research Unit (CRU) on Wednesday, 30 August 2023 and performing hybrid Good Clinical Practice (GCP) training on 30 – 31 August 2023. CRU Development and the GCP training were performed in collaboration with The Indonesian Association for The Study of Medicinals (IASMED) and Prodia the CRO.
As stipulated in the Decree of the Ministry of Health of the Republic of Indonesia Number HK.01.07/MENKES/1458/2023 regarding clinical research in hospitals, to perform clinical research in hospital, Clinical Research Unit should be established. The establishment of CRU is carried out to strengthen both quality and capacity in performing clinical research in hospital. Therefore, the clinical research that is performed in hospital can meet the applicable requirements and standards. RSUP M. Djamil Padang is collaborating with IASMED and the Site Management Organization (SMO) Department of Prodia the CRO for the CRU Development. These collaborations include site assessments, developing clinical research related standard operating procedures (SOP) and guidance of performing clinical research in hospital.
Along with CRU Launching, the Hybrid GCP training was also conducted by the hospital to ensure that all staff are trained and understand how to conduct Clinical Trial based on GCP standard. This course consists of 10 topics started from the Introduction of International Conference of Harmonization – Good Clinical Practices (ICH-GCP), Roles and Responsibility of Ethical Committee, Investigator Responsibilities, Sponsor & CRO Responsibilities and Preparation of Trial Site. These topics were presented by practitioners and experts in clinical trials. This GCP training was attended by 56 participants from RSUP Dr. M. Djamil Padang. During this training, all participants were enthusiastic in all sessions. In the end of the training, the participants took some test and obtained the certificate. <IIR>