抄録
The Institutional Review Board (IRB) should review and evaluate the clinical trial from the ethical and scientific viewpoints under the New Good Clinical Practice (GCP) We have constituted a Center for Clinical Trials since April 1999. The IRB is independent of the Center. However, the Center assists the IRB by pre-reviewing protocols of clinical trials from October 1999. The Pre-review Division in the Center consists of six medical doctors, three pharmacists, one nurse, one clinical laboratory staff and a member from medical affairs division, and reviews the clinical trial plan and written information for subjects in each trial. The Center submits the pre-reviewed results form to the IRB.
We studied whether or not our pre-reviewing in the Center is valuable to the IRB. the Pre-review Division listed 260 statements or questions in fifteen new clinical trials from October 1999 to March 2000; these were mainly concerned with the clinical trial plan, informed consent of subjects, clinical laboratory tests, etc. Average review time in the IRB was prolonged from 13.7±10.3 min to 21.2±8.6 min by discussing and evaluating clinical trials in more detail based on the information from the Pre-review Division (p<0.05).
As a result, we recognized that it was almost impossible for the IRB to change the clinical trial plan described by a sponsor, following the statements from the Pre-review Division. However, the records of the discussion in the IRB regarding all pre-reviewed results, statements and questions are kept. Accordingly, it is concluded that such records of discussion facilitate the proper and smooth conduction of the clinical trial in our hospital.
