Investigator-Initiated Specified Clinical Research AgreementInvestigator-Initiated Specified Clinical Research Agreement • December 16th, 2019
This Investigator-Initiated Specified Clinical Research Agreement (hereinafter “the Agreement”) is entered into by and between [Official Name of the Research Institution] (hereinafter “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 (Act No. 16, 2017) (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.
