Drug Evaluation Committee 2004-14 Points to Consider When Conducting a Single Clinical Trial at Multiple Medical Institutions
Related classification: Other
First published: Feb. 2005
Revised publication date: December 2021
Question
A university-affiliated hospital is treated as a separate hospital, and the same protocol, the same patient, and the same investigator (the physician is concurrently in charge of both the hospital and the center, and belongs to Department XX of the hospital and Department XX of the center, respectively) are used at the hospital affiliated with the Faculty of Medicine (hereinafter referred to as "medical hospital") and the affiliated XX Medical Center (hereinafter referred to as "center"). The same patient, same investigator, same protocol, same investigator (the investigator belongs to the same department at the hospital and the center, respectively), and the same investigator (the investigator belongs to the same department at the hospital and the center, respectively).
The IRB review request will be made by the director of the hospital and the center, respectively, and we are considering preparing CRFs (one for each site, two in total) and keeping records (at the hospital and the center, respectively), etc. Are there any GCP issues? If there are any procedures or documents that are considered necessary, please advise us.
Please also advise us of any procedures or documents that may be required. IRBs are established by the university and review requests from all affiliated hospitals.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If possible, it is preferable to conduct clinical trials within one facility. If it is unavoidable to use two sites, the procedures, etc., are likely to differ in various respects from those for a clinical trial conducted at one site, so as long as these points are fully considered, clarified, and appropriately addressed, we believe it is possible under GCP.
The following is a list of major points that may need to be considered.
- Contents of Explanatory Documents
- Method of obtaining consent
- Procedures for preparing case report forms
- Management of investigational products
- Treatment of subjects at the center when subjects are transferred from the center to the medical center
- Where information about the clinical trial is communicated within the medical institution
- How to notify the sponsor
- Procedures for accepting monitoring and auditing
- Details of termination reports to each site and where to submit them
- Response in the event of future regulatory investigations
- Preservation of clinical trial-related records and materials
We believe that there may be other issues that need to be considered when conducting a clinical trial, so we suggest that you and the sponsor thoroughly discuss the implementation of the clinical trial in accordance with your hospital's protocol and study protocol beforehand.
In addition, if such a two-center clinical trial is contemplated in the future, it would be desirable to establish a procedure.
In addition, the "Q&A on Conducting Clinical Trials of Pharmaceuticals, Medical Devices, and Regenerative Medicine Products under the Influence of New-type Coronavirus Infection (Updated May 26, 2020)" states that, in principle, it is appropriate to conduct and complete a clinical trial at a medical institution that can conduct the clinical trial independently, and that it is not appropriate to conduct a clinical trial at another medical institution where the subject is conducting the same trial. The Q&A is provided when subjects are administered investigational drugs or undergo evaluations stipulated in the study protocol at other medical institutions conducting the same clinical trial. Although this Q&A is related to conducting a clinical trial under the influence of a new type of coronavirus infection, we recommend that you refer to it.
Reason for revision of opinion
The opinion text has been partially changed in accordance with the release of the Q&A on Conducting Clinical Trials of Drugs, Medical Devices, and Regenerative Medicine Products under the Influence of New Type Coronavirus Infection (updated on May 26, 2020).