Pharmaceutical Administration and Regulations in Japan - Nihs
Pharmaceutical Administration and Regulations in Japan - Nihs
Pharmaceutical Administration and Regulations in Japan - Nihs
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trial, or the director of the medical<br />
<strong>in</strong>stitutions <strong>in</strong>volved.<br />
• When the trial is completed or<br />
discont<strong>in</strong>ued, the results obta<strong>in</strong>ed<br />
must be compiled <strong>in</strong> a cl<strong>in</strong>ical trial<br />
report. When the person conduct<strong>in</strong>g<br />
the cl<strong>in</strong>ical trial learns that the study<br />
results collected from the trial<br />
concerned were not attached to the<br />
application form as application data,<br />
this fact <strong>and</strong> the reason for it must be<br />
notified <strong>in</strong> writ<strong>in</strong>g to the directors of the<br />
medical <strong>in</strong>stitutions perform<strong>in</strong>g the<br />
trial.<br />
• Records related to the cl<strong>in</strong>ical trial<br />
must be reta<strong>in</strong>ed for the specified<br />
period.<br />
Chapter 4: St<strong>and</strong>ards for conduct of<br />
cl<strong>in</strong>ical trials (Articles 27 to 55)<br />
Provisions to be followed by the<br />
medical <strong>in</strong>stitutions perform<strong>in</strong>g cl<strong>in</strong>ical<br />
trials scientifically <strong>and</strong> ethically<br />
1) Provisions concern<strong>in</strong>g the<br />
Institutional Review Boards (IRB)<br />
(Articles 27 to 34)<br />
• An Institutional Review Board<br />
(IRB), which should meet the<br />
requirements specified <strong>in</strong> Article<br />
28, must be established by the<br />
director of the medical <strong>in</strong>stitution<br />
perform<strong>in</strong>g the trial to review <strong>and</strong><br />
discuss the proper conduct of<br />
<strong>Pharmaceutical</strong> <strong>Regulations</strong> <strong>in</strong> <strong>Japan</strong>:<br />
cl<strong>in</strong>ical trials <strong>and</strong> other matters<br />
related to the trials. (However, it<br />
is not always necessary to<br />
establish an IRB <strong>in</strong> each medical<br />
<strong>in</strong>stitution perform<strong>in</strong>g the study.)<br />
• The IRB must review the ethical<br />
<strong>and</strong> scientific appropriateness of<br />
the cl<strong>in</strong>ical trial subject to review<br />
on the basis of the documents<br />
specified <strong>in</strong> Article 32, <strong>and</strong> state<br />
its op<strong>in</strong>ion.<br />
• The person establish<strong>in</strong>g the IRB<br />
must keep records of meet<strong>in</strong>gs<br />
<strong>and</strong> prepare a summary <strong>and</strong><br />
reta<strong>in</strong> these documents for set<br />
periods such as 3 years after<br />
completion of the cl<strong>in</strong>ical study.<br />
The st<strong>and</strong>ard operat<strong>in</strong>g<br />
procedures, list of members, <strong>and</strong><br />
summary of meet<strong>in</strong>g records<br />
prepared for the IRB must be<br />
made public. On the PMDA<br />
webpage (http://www.pmda.go.jp),<br />
the name of the IRB, the name of<br />
the person establish<strong>in</strong>g the IRB,<br />
the address, <strong>and</strong> webpage<br />
address must be recorded to<br />
create an environment that<br />
facilitates acquisition of<br />
study-related <strong>in</strong>formation by<br />
cl<strong>in</strong>ical study collaborators <strong>and</strong><br />
keeps a wider public <strong>in</strong>formed<br />
(Notification No. 1001013 of the<br />
2011-3 - 103 -