Drug Evaluation Committee 2009-13 Filing of records when the clinical trial secretariat also serves as the secretariat of the Clinical Trial Review Committee
Related classification: Record keeping
First published: Jul 2009
Revised publication date: December 2021
Question
(1) Documents or records pertaining to a clinical trial
Regarding documents kept at a medical institution, is it necessary to separate the documents kept by the Chairperson and those kept by the Clinical Trial Review Committee?
Normally, the secretariat keeps the documents, but in the case of a hospital with an IRB, the secretariat of the clinical trial and the secretariat of the IRB serve concurrently and there is only one secretariat. In such a case, do we have to file the documents separately because the person who keeps the documents is different? I feel that even if we keep the documents separately for the Hospital Director and for the IRB Chairperson, the same documents will be kept in the end, and only the difference between the original and the copy will increase the number of documents.
We are an SMO and have attended several GCP on-site inspections. However, there are places where the pharmaceutical company asks if separate storage is necessary.
(2) Establishment of a clinical trial review committee
There is a clinic that is very positive about conducting clinical trials (it meets the requirements for a medical institution under Article 35), although it currently focuses on home care and does not have many patients who are eligible for clinical trials.
The clinic would like to set up an IRB because some clinics in the group are likely to be able to conduct clinical trials.
In that case, does this constitute an "IRB established by the head of the implementing medical institution" as stated in the requirements for the establishment of an IRB?
JPMA's Opinion
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1.The provisions on preservation of records include preservation by the person who established the investigational review board (GCP Article 34) and preservation pertaining to the implementing medical institution (GCP Article 41). In addition, Article 41, Paragraph 1, Guidance 1 of the GCP stipulates that "a person responsible for record keeping shall be designated for each record. The Guidance 1 of Article 41, Paragraph 1 of the GCP stipulates that "a person responsible for record keeping should be designated for each record.
In the case of a clinical trial at the same institution where the investigational review committee is established and the Chairperson is the same as the investigational review committee, the records specified in Article 34 (GCP) and Article 41 (GCP) are to be stored by the person who established the investigational review committee, and the records specified in Article 41 (GCP) are to be stored by the person who is in charge of record keeping in accordance with the instructions of the Chairperson of the institution. There is no problem if the person in charge of record keeping keeps the records appropriately, and there is no need to keep duplicate records. However, if a clinical trial review committee review is requested by another implementing medical institution, both parties need to keep the records respectively. -
2.It is possible for the director of a clinic to set up a clinical trial review committee in anticipation of future clinical trials. It is also possible for the directors of multiple clinics as a group to jointly establish a Clinical Trial Review Committee.
Although a medical institution can set up a clinical trial review committee, a medical corporation itself cannot set up a clinical trial review committee.
Reason for revision
We have reviewed the description in the Opinion and changed the referenced clauses.