The administrator of a core hospital for clinical research, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must carry out the following particulars:
臨床研究中核病院の管理者は、厚生労働省令の定めるところにより、次に掲げる事項を行わなければならない。
to develop and implement a plan concerning specified clinical research;
特定臨床研究に関する計画を立案し、及び実施すること。
when conducting specified clinical research jointly with other hospitals or clinics, to play a leading role in the implementation of specified clinical research;
to provide consultation, necessary information, advice and other assistance to other hospitals or clinics concerning the implementation of specified clinical research;
to provide training on specified clinical research;
特定臨床研究に関する研修を行うこと。
to systematically manage the various records listed in items (iii) and (iv) of Article 22-3; and
第二十二条の三第三号及び第四号に掲げる諸記録を体系的に管理すること。
other particulars specified by an Order of the Ministry of Health, Labour and Welfare.
その他厚生労働省令で定める事項
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