薬物治験審査委員会 (IRB) による治験実施状況の調査に関する検討

新GCP下の治験におけるIRBの役割

抄録

Under the new GCP, IRB should conduct continual reviews of each ongoing trial. Inthe Nippon Medical School Hospital, the IRB office is set up in the Clinical Pharmacology Center. We have examined the quality of clinical trials through simulated monitoringand auditing in Nippon Medical School Hospital from October to December, 1997. Nineclinical trials which included eleven patients were investigated. We checked the following13 items in the clinical trials: 1) progression of the trial, 2) investigators' documents, 3) existence of patients, 4) choice of investigators, 5) consent forms, 6) observanceof standards for registaration, 7) observance of standards for exclusion, 8) medicalexaminations, 9) utilized source documents, 10) accuracy of case report forms (CRFs) and source documents, 11) adverse events which should be reported, 12) correction in CRF, 13) observance of the IRB's requirements. All trials were properly executed withrespect to the existence of patients, consent forms, reported adverse events, correctionsin CRF, and observance of the IRB's requirements.
Using the list of 13 items, we could check on three aspects of the clinical trialsincluding the drug, the protocol and the investigator's procedures, and evaluate thequality of the clinical trials. IRB monitoring is very important to ensure the quality ofclinical trials in a hospital. Moreover, IRBs must be independent of the investigators andthe sponsors, and should develop and follow appropriate procedures for the continuationof the review after approval and the start of the clinical trials.