CENTER FOR TROPICAL MEDICINE, FM UGM

RETRAC REPORT- 1st Batch of Regional Course on Good Clinical Practice (GCP)

RETRAC REPORT

1st Batch of Regional Course on Good Clinical Practice (GCP)

Sept 4-6, 2015, Yogyakarta, Indonesia

 

Yogyakarta – Indonesia. Center for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada (CTM-UGM) with the support from WHO/TDR has successfully conducted the first batch Regional Course on Good Clinical Practice (GCP) at the Phoenix Hotel, Yogyakarta from September 4 to 6, 2015.

Good Clinical Practice is an international ethical and scientific standard for designing, conducting, analyzing and reporting clinical trials that involve participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well being of trial subjects are protected. It also ensures the credibility of the trial data. This course is dedicated to developing country research and development activities whose researchers are compelled to adhere to GCP in environments that may not be easily conducive to GCP requirements. The module provides an overview of what forces led to the landmark International Conference on Harmonization (ICH) that triggered the GCP through combination of interactive lectures, discussions, practical exercises – small group work, role-plays and preparation/review of records.

We distributed call for application of the course with deadline of application: July 30, 2015 and announcement of selection result: August 5, 2015.Thirty two applicants from Indonesia, Bangladesh, Nepal, Vietnam,  Sri Lanka and Cambodia submitted their application documents. Only 24 participants (10 groups) were selected as TDR scholarship recipients. They were Diannisa Ikarumi Enisar Sangun, Harry Freitag Luglio Muhammad and Dian Caturini Sulistyoningrum (Faculty of Medicine, UGM, INDONESIA), Harshini Nadeeka Vitharana, Galhenage Wasantha Kumudinie Jayakody, Kuruppu Arachchillage Shyamali Damayanthi Ratnayake (National Programme for Tuberculosis  Control and Chest Diseases,  SRI LANKA), KaziIstiaque Sanin, Towfida Jahan Siddiqua, Subhasish Das (International Centre for Diarrhoeal Disease Research, Bangladesh (Icddr,b), BANGLADESH), Jatu Aphridasari, Ratih Dewi Yudhani (Faculty of Medicine, Sebelas Maret University INDONESIA), Nguyen Cong Canh (Da Nang Hospital for Women and Children, VIETNAM), Geethani Nanditha Abeygunawardana, Jayakodi KankanangeManoj Nishantha Jayakodi (Ministry of Health Nugegoda, SRI LANKA), Sanjib Kumar Sharma, Gyanu Nepal Gurung, Pramila Rai, Shyam Sundar Budhathoki, Anup Ghimire, Bhawesh Koirala (B.P.Koirala Institute of Health Sciences, NEPAL), Ariesti Karmila, Moretta Damayanti (Faculty of Medicine, Universtiy of Sriwijaya, Mohammad Hoesin Hospital, INDONESIA), Charles Conrad Rambung, Fransiska Maria Natalia Hurint, RSUD Prof. Dr. W.Z. Johannes Kupang (Public Hospital), East Nusa Tenggara, INDONESIA)

Four resource persons facilitated in this course i.e. Varalakshmi Elango – India, Jarir At Thobari, Rovina Ruslami and Rina Triasih – Indonesia. Participants felt that this course is beneficial for them as researchers as well as clinicians particularly in conducting clinical trials. They recommended those who work in clinical trials to take this course to improve their practices in managing their research.The 2nd batch of Regional Course on GCP will be held again in Yogyakarta on August 2016 with providing up to 7 scholarships from WHO/TDR.

 

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Figure 1. Group discussion

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Figure 2. Facilitators and participants of GCP Regiona Course 2015

April 22, 2016

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