2019/09/04

(寄稿)

Essential Considerations for Requesting a Clinical Trial In-Country Representative

  Foreign sponsors, including start-up companies in the U.S., who are planning to develop pharmaceuticals and medical devices in Japan may want to outsource the Clinical Trial operations to CROs in Japan.  Japan CRO Association, consisted of leading CROs in Japan, formulate the guidance, “ Essential Considerations for Requesting a Clinical Trial In-Country Representative”, to help foreign sponsors meet the requirements set out by the Japanese regulatory authority.
  Here you can read the full document of the guidance.

 

Essential Considerations for Requesting a Clinical Trial In-Country Representative
<For Foreign Sponsors>

Policy Committee
Monitoring Working Team
Date of Issue: June 30, 2017

  We do not undertake any responsibility for troubles, loss, damage, and so on caused by using this document. Please refrain from reproducing any content of this document without permission. 

Foreword 
  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.
1. In any clinical trial in Japan, safety information is reported to the regulatory authority no later than 7 calendar days, in the earliest case, after first knowledge of incidence. Reporting obligations arise at the time of submitting a notification of a clinical trial plan. 
2. For safety information, the date the information is obtained by a foreign sponsor or by the ICCC, whichever is earlier, is regarded as the date for obtaining initial information.
3. A foreign sponsor and the ICCC must always include items on reporting safety information in any contract between them after understanding the description above. If there is an affiliate company in Japan, the extent of its involvement must be confirmed. 

  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


Table of contents 
Chapter 1.  Aim and scope of this document
Chapter 2. Items that should be checked at the time of outsourcing duties to ICCC
Chapter 3. Items that Foreign Sponsors need to understand when ICCC conducts duties

Please refer to the PDF data for details.
(Attachment)  https://fs.one-cmp.com/lsmip/files/user/%E6%B7%BB%E4%BB%981%20Clinical%20Trial%20In-Country%20Representative.pdf
(END)

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