薬理と治療

Abstract

Objectives　　Standard Operating Procedure（SOP）is needed to conduct investigator‒initiated clinical trials. SOP templates for drug and medical device have been released on website, however, preparation processes for SOP depends on the institutions conducting a clinical trial. Moreover, no templates for regenerative medicine products are released. Here we created of SOP templates for regenerative medicine products, and also revised SOPs for drugs and medical devices. Methods　　First, we searched the notifications and guidelines relating investigator‒initiated clinical trials. Then SOP templates for drug and medical device were updated to reflect the latest notifications and guidelines as of the end of March 2019. Then, based on them, SOP templates of regenerative medicine products were made. Results　　The drug and medical device SOP templates were updated according to the 18 notifications and 7 guidelines from December 2012 to March 2019, and a regenerative medicine product SOP templates were newly created according to the latest notifications and guidelines as of the end of March 2019. Conclusions　　The SOP templates for drugs, medical devices and regenerative medicine products were created and released on the JMACCT website. They can be browsed and used by clinical trial personnel. These SOP templates can also be used as an education and training material. We hope that the proper use of these templates will help reduce or prevent deviations from GCP and regulations, and help achieve the quality control goals.