Investigator-Initiated Clinical Research Agreement (Draft)Investigator-Initiated Clinical Research Agreement • January 28th, 2020
This Investigator-Initiated Specified Clinical Research Agreement (hereinafter “the Agreement”) is entered into by and between [Official Name of the Research Institution] (hereinafter “Representative Research Institution”) and XXXX (hereinafter “Company”), in view of the fact that the investigator- initiated clinical research (hereinafter “the Research”) set out in the following Research Implementation Particulars (hereinafter “the Particulars”) applies to the specified clinical research (hereinafter “Specified Clinical Research”) provided for in Article 2, paragraph (2) of Clinical Trials Act (hereinafter “the Act”), under Article 32 of the Act, Article 88 of the Ordinance for Enforcement of the Act (hereinafter “the Ordinance”) and other applicable laws and related notifications, concerning implementation of the Research.
AMDD (American Medical Devices and Diagnostics Manufacturers' Association) Investigator-Initiated Clinical Research Agreement (Sample)Investigator-Initiated Clinical Research Agreement • June 30th, 2016
This document is a sample investigator-initiated clinical research agreement applicable to the situation where a company, etc. provides funds to a research institution, etc. pursuant to an agreement to conduct investigator-initiated clinical research in which its medical devices are assessed. It was prepared by AMDD with reference to the Ethical Guidelines for Medical and Health Research Involving Human Subjects (Ministry of Education, Culture,Sports, Science and Technology and Ministry of Health, Labor and Welfare, 2014), the Guideline Concerning Clinical Research Using Approved Medical Devices (the Japan Federation of Medical Devices Associations, April 1, 2015), Q&A Concerning Involvement of Business Operators in Clinical Research (the Japan Fair Trade Council of the Medical Device Industry Notification No. 2497, July 30, 2015), and the Investigator-Initiated Clinical Research Agreement (Sample) of the Japanese Association of Pharmaceutical Medicine (JAPhMed).
