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.