Drug Evaluation Committee 2009-01 Transfer of Investigational New Drugs between Investigator Sites
Related classification: Other
First published: Jul 2009
Question
Background
As an exceptional measure to ensure a reliable supply of investigational drugs in global clinical trials, a procedure has been established for transferring investigational drugs from the Investigator Site where the investigational drug was delivered to another Investigator Site. In doing so, "the history of the investigational drug at the Investigator Site is evaluated to confirm the appropriateness of the investigational drug to be transferred. This includes a review of monitoring reports and records of storage conditions at the originating Investigator Site, as well as a check of the physical integrity of the investigational drug." and that the investigational drug was properly stored.
Question
If the appropriateness of the investigational drug is confirmed, we do not see any problem with using it at another Investigator Site. In that case, is there any problem under GCP if the sponsor does not collect the investigational drug once and deliver it to another Investigator Site, but transfers it from one site to another? There are various possible methods of transfer, such as the monitor collecting the investigational new drug and delivering it to another Investigator Site on the same day, or outsourcing the transportation of the investigational new drug. We would appreciate it if you could enlighten us.
JPMA's Opinion
Article 16, paragraph 4 of the GCP stipulates that "The sponsor must package the investigational drug and deliver it to the Investigator Site to prevent contamination or deterioration during transport and storage. Article 17 of the GCP stipulates that "the sponsor must deliver the investigational new drug to the site. Article 17 of the GCP also stipulates that "The sponsor shall deliver to the Investigator Site an investigational drug manufactured at a manufacturing facility equipped with the necessary structural facilities to ensure the quality of the investigational drug and with appropriate manufacturing control and quality control methods under the sponsor's responsibility. The provision also stipulates that "the sponsor is responsible for the delivery of the investigational new drug to the site of the clinical trial. Therefore, even in the exceptional case of transferring an investigational drug once delivered to an Investigator Site to another Investigator Site, the sponsor must be responsible for the transfer. The sponsor must be responsible for the transfer.
It depends on the content of the sponsor's protocol, but if a qualified person on the sponsor's side is able to "evaluate the history of the investigational drug at the Investigator Site" (check the appropriateness of the investigational drug to be transferred) at the site where the drug is stored, it should be possible to transfer the investigational drug from the site to another Investigator Site. If the investigational new drug can be transferred from one site to another, it should be possible to transfer the investigational new drug to another site. However, in such cases, it is necessary to take necessary measures such as preparing a procedure manual for ensuring quality control, transport and delivery, and concluding a contract with the relevant carrier, etc. (Guidance 5, Article 17 of GCP). (Guidance 5, Article 17 of GCP).
The "evaluation of the history of the investigational drug at the Investigator Site" is a matter for the sponsor to determine according to the characteristics of the investigational drug, but it should be done in cooperation with the Investigator Site and sufficient evidence should be left behind.