Drug Evaluation Committee 2023-14 Rotating IRB deliberations
Related classification: Clinical Trial Review Board
Date of first publication：August 2023
Question
I have a question regarding the IRB rotating deliberations. We would like to utilize both in-person and rotating reviews at our hospital after the coronary disaster has ended.
We would appreciate your guidance on the following question.
Currently, when there are no new clinical trials to be discussed at our hospital, we conduct a rotating review by e-mail as a special measure for coronavirus disasters in accordance with the MHLW's administrative communication "Handling of Review by the Review Committee for Clinical Trials Related to New-type Coronavirus Infections". Since there have been no particular problems with the rotating review at our hospital so far, and since the rotating review was conducted even before the coronavirus disaster, for example at the 15th meeting of the Infectious Diseases Subcommittee of the Health Sciences Council of the Ministry of Health, Labour and Welfare (held on February 4, 2008), we will conduct face-to-face review in the following conditions from now on, In other cases, we would like to continue the review by rotation, utilizing the cloud-based document management system "Agatha". Unlike e-mail, the cloud-based document management system "Agatha" provides each IRB member with an individual ID and a one-time password in addition to a password to log in to the system. The IRB is a cloud-based document management system. If IRB deliberations using the cloud-based document management system do not violate GCP, we plan to seek the understanding of the sponsor and revise the Standard Operating Procedures after obtaining the approval of the committee members at the Clinical Trial Review Committee.
Please let us know if IRB deliberations using the cloud-based document management system is a violation of GCP or not, and if not, whether the proposed conditions for holding IRB meetings in person at our hospital will be acceptable.
Conditions for holding face-to-face IRB meetings (draft)
Discussion of a newly requested clinical trial
Continuation review in accordance with GCP (GCP Article 31, Paragraph 1 for pharmaceutical products)
Deliberations on the appropriateness of continuing the clinical trial, to be held at least once a year
Deliberations on matters related to safety from the viewpoint of protection of test subjects
First report of serious adverse events that occurred in our hospital
The first report of a serious adverse event that occurred in our hospital, however, is limited to cases where a causal relationship with the investigational drug cannot be ruled out. The IRB Chair will decide whether or not to review the second and subsequent reports in person.
Safety information reports that require revision of the protocol or consent document will be reviewed.
The IRB chairperson will decide whether or not to conduct a face-to-face review for the second and subsequent reports.
When deemed necessary by the IRB chairperson
○ When the IRB member requests an in-person review after review of distributed IRB materials
Pharmaceutical Cooperative Opinion
We believe that the rotating review by e-mail, etc. was approved as a special exceptional measure during the outbreak of new coronavirus infection, and is not applicable in normal times.
Although the method you have presented here allows interactive exchange of opinions on the cloud, it is difficult to ensure the same quality of deliberations as those conducted in person, because it is impossible to exchange opinions in real time and to guarantee that all committee members are participating in the discussions. Therefore, except for minor changes related to ongoing clinical trials, we believe that, in principle, face-to-face meetings should be conducted in a manner that allows deliberations to be conducted with the same quality as face-to-face meetings.