Beyond the provisions of Article 21, paragraph (1) (excluding items (i) and (ix)), a core hospital for clinical research is to have the following personnel and facilities and must prepare the following records, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare:
physicians, dentists, pharmacists, nurses, and other employees involved in clinical research in the numbers prescribed by an Order of the Ministry of Health, Labour and Welfare;
厚生労働省令で定める員数の臨床研究に携わる医師、歯科医師、薬剤師、看護師その他の従業者
an intensive care unit;
集中治療室
records concerning medical treatment and clinical research;
診療及び臨床研究に関する諸記録
the facilities listed in item (iv) through item (viii) of Article 22; and
第二十二条第四号から第八号までに掲げる施設
other facilities as prescribed by an Order of the Ministry of Health, Labour and Welfare.
その他厚生労働省令で定める施設
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