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NCGM STUDY MONITORING VISIT


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Study site monitoring is one of the effective ways to ensure compliance and data accuracy during research conduct. The purpose of the monitoring program is to ensure a study is conducted ethically, safely, and in compliance with the protocol, and institutional policies and procedures. The National Center for Global Health and Medicine (NCGM) conducted a study monitoring visit to MochtarRiady Institute for Nanotechnology (MRIN) on December 13, 2022. The visit was to observe the implementation of the clinical study on novel COVID-19 detection at the Indonesian site, as part of a collaborative study between NCGM, MRIN, and the University of the Phillippines. 
 
The NCGM team consisted of Tetsuo Miura (Study Manager), Takashi Kobayashi (Clinical Data Manager), and Marlinang D Siburian (Regional Manager for Indonesia). They were welcomed by Prof. dr.Irawan Yusuf, Ph.D. (MRIN President), and Dr.rer. nat. IvetSuriapranata as Principal Investigator. For this study monitoring, NCGM Team also paid a visit to recruitment sites at Siloam Hospital Lippo Village, and Siloam Hospital KelapaDua. The monitoring concluded with a visit to MRIN’s laboratory/ facility and source document verification. 
 
The visit recognized that the regional site and laboratory showed an effective management control framework in which compliance and data accuracy were able to be verified.  The site is well-governed to support the study, and staff roles and responsibilities are clearly documented and communicated.


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