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S055-3

Clinical Trial in Psychiatric Hospital

Donny Tsang

Kaohsiung Municipal Kai- Syuan Psychiatric Hospital, Taiwan

Background/Objective: Kaohsiung Kai-Syuan Psychiatric Hospital (KSPH) had set up Institutional
Review Board (IRB) since 2003 and also developed into clinical studies for years. This new
development of clinical trial center (CTC) began on 2010 & set up the goal of economic independent
from the hospital foundation.

Method: The essential goal are 「No research without IRB」, active involve in the related meetings,
and also try to contact with the CROs. During the initial stage we ask our doctors to get the global
certification for Clinical researches after our reading group. We got 5 staff passed the Clinical
Principle Investigator (CPI) test & also start our second stage. Second stage was to reform &
progress of IRB. Also we pass the international accreditation by FERCAP too. During the last 4
years we set up a special room for clinical researches that got the fund support from our government
too.

Result: Recent 5 years we finish more then 50 clinical trials and also made the administrative
regulation that we finished more than 150. SOP (Standard Operation Procedure) rules & revised
annually.

Conclusion: Also we try to improve our procedures by regular & irregular internal audit too. We will
show these processes to discuss the future plans.