Drug Evaluation Committee 2015-22 Changes to Clinical Trial Review Committees during Clinical Trials
Related classification: Clinical Trial Review Committee
Date of first publication: December 2015
Question
We have started a clinical trial network between our hospital and another hospital this year, and we have received a consultation from the person in charge (CRO) of the same clinical trial that has already been approved and is being conducted at each hospital, asking if the clinical trial can be included in this clinical trial network.
We believe that one of the original purposes of the Clinical Trial Network is to improve the efficiency of clinical trial procedures through deliberations at the Central Clinical Trial Review Committee (at the main hospital) and unified SOPs, but GCP stipulates consistent deliberations by the same Clinical Trial Review Committee. If this clinical trial is subject to the SOP, would it still be a problem if the investigational review committee to be reviewed at other hospitals changes during the course of the clinical trial? If this is possible, what procedures would be necessary?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in your question, the investigational review committee is required to conduct consistent investigations and deliberations from the start to the end of the clinical trial (GCP Article 27, Paragraph 1, Guidance 2). If it is considered appropriate to transfer the investigation and deliberation to the central IRB and joint IRBs conducting the same clinical trial during the clinical trial period, the following points should be considered and appropriately transferred between the site and the IRB to be transferred in order to ensure the consistency under the agreement with the sponsor.
Points to keep in mind on the part of the site/sponsor to be transferred
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(a) Record of the reason and reasonableness of the transferA record should be kept of the reason for the transfer and the appropriateness of the transfer.
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(b) The head of the siteThe head of the site should contract with the new IRB establisher.
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(c) The investigator must be informed of the transfer of the subject.The investigator should explain to the subject that the IRB has been changed.
Items to be considered by the IRB receiving the transfer
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(a) Record of the reason and reasonableness of the transfer(b) The reason and appropriateness of transferring the IRB in the middle of a clinical trial shall be confirmed.
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(b) The head of the siteConfirming that there are no ethical and scientific problems with the continued review of the clinical trial.
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(c) The investigator must be informed of the transfer of the subject.Confirming that the subject will be given appropriate explanations in the explanatory document.
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(d) To confirm that there are no excesses or deficiencies in the documents to be transferred.Confirm that there are no excesses or deficiencies in the documents to be transferred.
In addition to the materials normally required for the initial review, the following materials should also be submitted to the IRB for investigation and deliberation.
- Outline of the site
- Status of the clinical trial (documents submitted for the annual continuing review)
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As of December 2023
Reference
Grant-in-Aid for Practical Use of Medical Technology (MHLW Science Research Grants), "Research on Activation of Clinical Trial Network that Can Contribute to Improvement of Case Concentration, etc." (H25-Medical Technology-Designation-014), 2013-2014 General Research Report, Principal Investigator: Manabu Yamamoto (March 2015)