A hospital that meets the following requirements for playing a central role in the implementation of clinical research may bear the name "core hospital for clinical research", with the approval of the Minister of Health, Labour and Welfare:
病院であつて、臨床研究の実施の中核的な役割を担うことに関する次に掲げる要件に該当するものは、厚生労働大臣の承認を得て臨床研究中核病院と称することができる。
having the capability of planning and implementing a project on specified clinical research (meaning clinical research conducted in accordance with the standards specified by an Order of the Ministry of Health, Labour and Welfare; the same applies hereinafter);
特定臨床研究（厚生労働省令で定める基準に従つて行う臨床研究をいう。以下同じ。）に関する計画を立案し、及び実施する能力を有すること。
having the capability of playing a leading role in the implementation of the specified clinical research, in the case where specified clinical research is to be implemented jointly with other hospitals or clinic;
having the capability of providing consultation, necessary information, advice and other assistance to other hospitals or clinics concerning the implementation of specified clinical research;
having the capability of providing training on specified clinical research;
特定臨床研究に関する研修を行う能力を有すること。
having the names of clinical departments amongst its clinical departments, as prescribed by an Order of the Ministry of Health, Labour and Welfare;
その診療科名中に厚生労働省令で定める診療科名を有すること。
having facilities to hospitalize more patients than prescribed by an Order of the Ministry of Health, Labour and Welfare;
厚生労働省令で定める数以上の患者を入院させるための施設を有すること。
the personnel meet the requirements prescribed by the Order of the Ministry of Health, Labour and Welfare set forth in Article 22-3;
その有する人員が第二十二条の三の規定に基づく厚生労働省令で定める要件に適合するものであること。
having facilities provided for in Article 21, paragraph (1), items (ii) through (viii) and (x) through (xii), and Article 22-3, items (ii), (v) and (vi);
第二十一条第一項第二号から第八号まで及び第十号から第十二号まで並びに第二十二条の三第二号、第五号及び第六号に規定する施設を有すること。
the buildings and equipment of the facility meet the requirements prescribed by the Order of the Ministry of Health, Labour and Welfare set forth in Article 21, paragraph (1) and Article 22-3 and Prefectural Ordinances set forth therein; and
beyond what is listed in each of the preceding items, the requirements specified by an Order of the Ministry of Health, Labour and Welfare concerning the implementation of specified clinical research are met.
In granting approval as set forth in the preceding paragraph, the Minister of Health, Labour and Welfare must hear the opinions of the Social Security Council in advance.
厚生労働大臣は、前項の承認をするに当たつては、あらかじめ、社会保障審議会の意見を聴かなければならない。
A facility that is not a core hospital for clinical research is not to bear the name "core hospital for clinical research" or a name that may cause it to be mistaken for such.
臨床研究中核病院でないものは、これに臨床研究中核病院又はこれに紛らわしい名称を称してはならない。
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