2024 年 55 巻 4 号 p. 203-208
In medical institutions, there are few investigator sites that actually deliver investigational drugs to participants or investigator sites that establish procedures for such delivery. However, it is expected that medical institutions will need to prepare for the delivery of investigational drugs to participants' homes due to the rapid spread of emerging infectious diseases and disasters, as well as the international spread of decentralized clinical trials. This time, we created “Points to note when establishing procedures for delivering investigational drugs from medical institutions to participants” and “Flowchart for delivering investigational drugs from medical institutions to participants”. In the future, when creating “procedure manual for delivering investigational drugs from medical institutions to participants”, it will be necessary to consider whether “Points to note when establishing procedures for delivering investigational drugs from medical institutions to participants” and “Flowchart for delivering investigational drugs from medical institutions to participants” are useful. In addition, it is expected that, in the future, decentralized clinical trials will become more widespread internationally, and related regulations will be revised accordingly. Therefore, we would like to consider updating “Points to note when establishing procedures for delivering investigational drugs from medical institutions to participants” and “Flowchart for delivering investigational drugs from medical institutions to participants” in response to this.
