Knowledge and skills on Good Clinical Practice (GCP) has become main requirement for any qualified clinical studies including IDAMS Study that is now conducted in Yogyakarta. IDAMS Study is a multicenter study which is held in 6 countries funded by European Commission and aims to conduct a clinical evaluation of Dengue and identification of risk factors for severe disease. During their last year visit, clinical monitor for this study found some problems particularly in filling the Case Report Form and Informed consent process. It was suggested that it is needed a GCP training particularly for health staff who are newly involved in this study in order to protect human subjects and obtain a credible data.
Center for Tropical Medicine, Faculty of Medicine UGM as WHO-TDR Regional Training Center has conducted several courses on GCP since 2010. CTM FM UGM conducted successfully the 2nd Batch of Training on GCP for IDAMS Study which was held in Yogyakarta on February 7-8, 2015 and was delivered by 2 resourceful facilitators. This 2 day intensive course trained 19 participants consisting of medical doctors, nurses, admission staff and lab technicians from 4 main study sites involved in this study i.e GMC Clinic and 3 Public Health Centers (Umbulharjo, Jetis and Tegalrejo). With adult learning approach, 7 modules that are adjusted to the situation of IDAMS Study were delivered through interactive lectures, study cases and discussions. Participants were assessed through their active participation in the discussion and in the course evaluation. The outcome of this course which is to increase participants’ knowledge and understanding on GCP principles which can be applied in IDAMS study, are considerably achieved in this training.