Drug Evaluation Committee 2008-12 Dates of accrual for continuing review
Related classification: Clinical Trial Review Committee
First published: January 2009
Question
Background
July 4, 2005: Date of initial IRB review
July 7, 2005: Date of initial clinical trial agreement
April 2006: Continuing review is scheduled in July 2006, but the date of the meeting is July 11, confirming to the Clinical Trial Office that there is no problem with the elapse of more than one year from the date of the initial IRB review (this is recorded in the monitoring report).
July 11, 2006: Continuing review
Question
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1.According to Article 31 of GCP, when the duration of a clinical trial exceeds one year, a continuing review is to be conducted at least once a year. Is it common practice to conduct the continuing examination within 365 days from the date of the initial contract?
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2.If we were to use the initial contract date as the starting date, we would have no problem with an IRB review in the same month one year later, as long as the above measures are taken.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 31, Paragraph 1 of the GCP stipulates that when the duration of a clinical trial exceeds one year, the opinion of the Investigational Review Committee on the appropriateness of continuing the clinical trial at the site shall be obtained at least once a year. However, the GCP Ministerial Ordinance or Guidance does not explain the starting date of "once a year or more. However, considering that the "duration of a clinical trial" is the period during which medication, observation, etc. are conducted as stipulated in the protocol, we believe that it is acceptable to set the starting date as the date of conclusion of the clinical trial agreement, rather than the date of the first meeting of the Clinical Trial Review Committee.
However, as long as the appropriateness of continuing a clinical trial can be appropriately reviewed, I think it is acceptable to have a gap of a few days depending on the setting of the date of the Clinical Trial Review Committee meeting.
The purpose of the continuing review by the Investigational Review Committee is to review the status of the clinical trial from the perspective of protecting the human rights, safety and welfare of the subjects, so it may be necessary to set the timing of the continuing review earlier than one year, depending on the risks to the subjects.