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
We have a clinic that is very open to a clinical trial (it meets the requirements of an Investigator Site under Article 35), although it currently focuses on home care and does not have many patients eligible for a clinical trial.
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, would it be considered an "IRB established by the head of the Investigator Site" as stipulated in the requirements for the establishment of an IRB?
JPMA's Opinion
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1.The regulations stipulate the preservation of records by the person who established the IRB (Article 34 of the GCP) and by the Investigator Site (Article 41 of the GCP). In addition, Article 41, Paragraph 1, Guidance 1 of the GCP stipulates that "a person responsible for record retention 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 Investigator Site as the investigator who established the investigator committee and the Chairperson of the Investigator Site, the records specified in Article 34 (GCP Article 34) and Article 41 (GCP Article 41) are to be stored by the person who established the investigator committee, and the records specified in Article 41 (GCP Article 41) are to be stored by the person who is in charge of record keeping in accordance with the instructions of the Chairperson of the Investigator Site. 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 another Investigator Site requests a review by the Clinical Trial Review Committee, both parties must keep their own records. -
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.