The following points are the most important to be understood and followed with regard to clinical trials conducted in Japan. The regulatory authority in Japan has expressed significant concerns regarding the following items, which must be performed without fail.
In association with the guidance documents “Essential Considerations on Requesting a Clinical Trial In-Country Representative <For Foreign Sponsors> issued by Japan CRO Association, June 2017
* Clinical Trial In-Country Representative is referred to as In-country Clinical Care-taker (ICCC) in this document
The Guideline stipulates the basic principles to continue the business activities by ensuring the reliabilities and quality of contracting services.
The Guidelines aim at increasing the clients’(prospective sponsor) reliabilities and developing by observing the Guideline by each Association Member and its further expansion and growth in the entire industry.