Drug Evaluation Committee 2009-08 Adjournment of Clinical Trial Review Committee (Part 2)
Related classification: Clinical Trial Review Committee
First published: Jul. 2009
Question
We are writing to inform you that one of our supported medical institutions has a clinic that is scheduled to close due to the director's poor health, and we would like to know the procedures for closing the Clinical Trial Review Committee established at the said institution.
Background
- There is only one doctor, the director.
- The clinic is scheduled to close in December of this year
- There is a trial currently underway (subject handling is scheduled to end in the fall of this year, and a completion report is scheduled by the end of the year, but just in time).
- Currently accepting deliberations from other medical institutions (there is a possibility that the trial will not be completed in time for the end of this year).
- The clinic is a tenant, and the lease is up for renewal at the end of December. If possible, they would like to withdraw without renewing the contract at the end of December.
- Regarding the IRB that has been established within the hospital, the membership is entirely composed of outside members
Questions
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Is it possible to establish an IRB for another medical institution with the same members while the current IRB is still functioning?
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If the IRB is newly established as an IRB of another medical institution without changing the composition of IRB members, is it possible to take over the deliberations of the trial currently being conducted?
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If the trial is not completed in time for the closure of the medical institution, is it possible to entrust the deliberations to another IRB, even from the middle of the trial, considering the situation to be unavoidable?
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（If (3) is not possible, is it possible for the IRB to continue to exist as an IRB until these trials are completed, even after the medical institution's practice ends at the end of December this year? If so, for how long? (Is it the date of withdrawal of advocacy or the date of withdrawal from the location of the medical institution?)
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Where should clinical trial records be stored after the closure of a medical institution?
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Are there any other tasks to be performed by the medical institution regarding IRB closure?
We understand that under GCP, the same IRB must deliberate on a clinical trial from its start to its end, but we are wondering how we should deal with the sudden closure of the clinic during the implementation of a clinical trial when this is not possible.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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There is no problem with concurrently serving as a member of more than one clinical trial review committee. If the head of another medical institution is judged to be qualified, it is possible that another investigational review committee consisting of exactly the same members could be established.
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Please refer to question No. ( 2007-14: Adjournment of a Clinical Trial Review Committee - Part 1 ) for the actions to be taken when a Clinical Trial Review Committee is adjourned.
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GCP stipulates consistent deliberations by the same Clinical Trial Review Committee. As long as a clinical trial review committee is established and functioning, it is considered that deliberations should be conducted by the same clinical trial review committee. If it has already been decided to close the investigational review committee, please refer to question number ( 2007-14: Closure of the investigational review committee - Part 1 ).
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If the medical institution is abolished in accordance with the Medical Care Act, the clinical trial review committee established by the head of the medical institution would also have to be closed.
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Medical records, etc., are required to be retained for the period stipulated in the Medical Practitioners Law, and of these, medical records, etc., which are the source documents for the clinical trial, must be retained in compliance with the period stipulated in the GCP. In the event that the implementing medical institution is discontinued, measures must be taken to ensure that the medical records are consigned to another medical institution or SMO for continued preservation for the period specified in these related laws and regulations. In this case, it may be necessary to conclude a contract for preservation with the consignee to clarify personal information protection, preservation period, location, etc. It is desirable for the medical institution to succeed to the preservation of the medical record among the source documents.
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Please refer to question number ( 2007-14: Adjournment of Clinical Trial Review Committee - Part 1 ).