一医薬品等製造販売業者又はその特殊関係者（医薬品等製造販売業者と厚生労働省令で定める特殊の関係のある者をいう。以下同じ。）から研究資金等（臨床研究の実施のための資金（厚生労働省令で定める利益を含む。）をいう。以下同じ。）の提供を受けて実施する臨床研究（当該医薬品等製造販売業者が製造販売（医薬品医療機器等法第二条第十三項に規定する製造販売をいう。以下同じ。）をし、又はしようとする医薬品等を用いるものに限る。）

(i)clinical trials implemented receiving research funds or other benefits (meaning funds for the implementation of clinical trials (including benefits specified by Order of the Ministry of Health, Labour and Welfare); the same applies below) provided by a holder of marketing authorization for pharmaceuticals, etc. or a specially related person (meaning a person who has a special relationship with the holder of marketing authorization for pharmaceuticals, etc. as specified by Order of the Ministry of Health, Labour and Welfare; the same applies below) (limited to such clinical trials implemented using pharmaceuticals, etc. that are marketed (meaning marketing provided for in Article 2, paragraph (13) of the Pharmaceuticals and Medical Devices Act; the same applies below) or intended to be marketed by the holder of marketing authorization for pharmaceuticals, etc.); or

二次に掲げる医薬品等を用いる臨床研究（前号に該当するものを除く。）

(ii)clinical trials implemented using pharmaceuticals, etc. stated in the following items (excluding the clinical trials that fall under the preceding item):

一医薬品医療機器等法第二条第一項に規定する医薬品（同条第十四項に規定する体外診断用医薬品を除く。）

(i)pharmaceuticals provided for in Article 2, paragraph (1) of the Pharmaceuticals and Medical Devices Act (excluding in-vitro diagnostics provided for in paragraph (14) of that Article);

二医薬品医療機器等法第二条第四項に規定する医療機器

(ii)medical devices provided for in Article 2, paragraph (4) of the Pharmaceuticals and Medical Devices Act; and

三医薬品医療機器等法第二条第九項に規定する再生医療等製品

(iii)regenerative medicine products provided for in Article 2, paragraph (9) of the Pharmaceuticals and Medical Devices Act.

一臨床研究の実施体制に関する事項

(i)matters concerning the system for implementing clinical trials;

二臨床研究を行う施設の構造設備に関する事項

(ii)matters concerning buildings and equipment at facilities where clinical trials are implemented;

三臨床研究の実施状況の確認に関する事項

(iii)matters concerning confirmation of the state of implementation of clinical trials;

四臨床研究の対象者に健康被害が生じた場合の補償及び医療の提供に関する事項

(iv)matters concerning compensation and provision of medical care upon occurrence of health damage to clinical trial subjects;

五特定臨床研究（前条第二項第一号に掲げるものに限る。）に用いる医薬品等の製造販売をし、又はしようとする医薬品等製造販売業者及びその特殊関係者の当該特定臨床研究に対する関与に関する事項

(v)matters concerning involvement of a holder of marketing authorization for pharmaceuticals, etc. which markets or intends to market pharmaceuticals, etc. used for specified clinical trials (limited to those stated in paragraph (2), item (i) of the preceding Article) and their specially related person in the specified clinical trials; and

六その他臨床研究の実施に関し必要な事項

(vi)other necessary matters for the implementation of clinical trials.

一氏名又は名称及び住所並びに法人にあっては、その代表者の氏名

(i)the person's name and address, and the name of the representative in the case of a corporation;

二特定臨床研究の目的及び内容並びにこれに用いる医薬品等の概要

(ii)the purpose and details of specified clinical trials, and the outline of pharmaceuticals, etc. used;

三特定臨床研究の実施体制に関する事項

(iii)matters concerning the system for implementation of specified clinical trials;

四特定臨床研究を行う施設の構造設備に関する事項

(iv)matters concerning buildings and equipment at facilities where specified clinical trials are conducted;

五特定臨床研究の実施状況の確認に関する事項

(v)matters concerning confirmation of the state of implementation of specified clinical trials;

六特定臨床研究の対象者に健康被害が生じた場合の補償及び医療の提供に関する事項

(vi)matters concerning compensation and provision of medical care upon occurrence of health damage to specified clinical trial subjects;

七特定臨床研究（第二条第二項第一号に掲げるものに限る。）に用いる医薬品等の製造販売をし、又はしようとする医薬品等製造販売業者及びその特殊関係者の当該特定臨床研究に対する関与に関する事項

(vii)matters concerning involvement of a holder of marketing authorization for pharmaceuticals, etc. which markets or intends to market pharmaceuticals, etc. used for specified clinical trials (limited to those stated in Article 2, paragraph (2), item (i)) and their specially related person in the specified clinical trials;

八特定臨床研究について第二十三条第一項に規定する審査意見業務を行う同条第五項第二号に規定する認定臨床研究審査委員会（以下この章において「認定臨床研究審査委員会」という。）の名称

(viii)the name of the certified review board provided for in Article 23, paragraph (5), item (ii) which performs operations for reviews and opinions as provided for in paragraph (1) of that Article for specified clinical trials (referred to below as the "certified review board" in this Chapter); and

九その他厚生労働省令で定める事項

(ix)other matters specified by Order of the Ministry of Health, Labour and Welfare.

一次項の規定による意見の内容を記載した書類

(i)a document stating the details of opinions under the following paragraph; and

二その他厚生労働省令で定める書類

(ii)other documents specified by Order of the Ministry of Health, Labour and Welfare.

一第五条第三項（第六条第二項において準用する場合を含む。）の規定により意見を求められた場合において、実施計画について臨床研究実施基準に照らして審査を行い、特定臨床研究を実施する者に対し、特定臨床研究の実施の適否及び実施に当たって留意すべき事項について意見を述べる業務

(i)if opinions are requested pursuant to Article 5, paragraph (3) (including as applied mutatis mutandis pursuant to Article 6, paragraph (2)), operations to review the trial plan in light of the clinical trial standards and to provide opinions to a person who implements specified clinical trials about whether the specified clinical trials are appropriate and matters to be noted in the implementation of the specified clinical trials;

二第十三条第一項の規定により報告を受けた場合において、必要があると認めるときは、特定臨床研究実施者に対し、当該報告に係る疾病等の原因の究明又は再発防止のために講ずべき措置について意見を述べる業務

(ii)if a report is received pursuant to Article 13, paragraph (1), if it finds it necessary, operations to provide opinions to the specified clinical trial conductor about measures to be taken to investigate the cause or prevent recurrence of the disease, etc. related to the report;

三第十七条第一項の規定により報告を受けた場合において、必要があると認めるときは、特定臨床研究実施者に対し、当該報告に係る特定臨床研究の実施に当たって留意すべき事項又は改善すべき事項について意見を述べる業務

(iii)if a report is received pursuant to Article 17, paragraph (1), if it finds it necessary, operations to provide opinions to the specified clinical trial conductor about matters to be noted or improved in the implementation of the specified clinical trials related to the report; and

四前三号のほか、必要があると認めるときは、その名称が第五条第一項第八号の認定臨床研究審査委員会として記載されている実施計画により特定臨床研究を実施する者に対し、当該特定臨床研究を臨床研究実施基準に適合させるために改善すべき事項又は疾病等の発生防止のために講ずべき措置について意見を述べる業務

(iv)in addition to the preceding three items, if it finds it necessary, operations to provide opinions to the person who implements specified clinical trials pursuant to the trial plan in which its name is stated as the certified review board under Article 5, paragraph (1), item (viii), about matters to be improved to cause the specified clinical trials to conform to the clinical trial standards, or measures to be taken to prevent the occurrence of disease, etc.

一氏名又は名称及び住所並びに法人にあっては、その代表者（法人でない団体にあっては、その代表者又は管理人）の氏名

(i)the person's name and address, and the name of the representative in the case of a corporation (or the representative or administrator in the case of an organization without legal personality);

二臨床研究審査委員会の名称

(ii)the name of the clinical trials review board;

三臨床研究審査委員会の委員の氏名

(iii)the names of members of the clinical trials review board;

四審査意見業務を行う体制に関する事項

(iv)matters concerning the system under which operations for reviews and opinions are performed; and

五その他厚生労働省令で定める事項

(v)other matters specified by Order of the Ministry of Health, Labour and Welfare.

一臨床研究に関する専門的な知識経験を有する委員により構成され、かつ、審査意見業務の公正な実施に支障を及ぼすおそれがないものとして厚生労働省令で定める体制が整備されていること。

(i)the clinical trials review board is composed of members who have expert knowledge and experience concerning clinical trials and the system specified by Order of the Ministry of Health, Labour and Welfare as being unlikely to adversely affect fair performance of operations for reviews and opinions has been established;

二審査意見業務の実施の方法、審査意見業務に関して知り得た情報の管理及び秘密の保持の方法その他の審査意見業務を適切に実施するための方法に関する業務規程が整備されていること。

(ii)operational rules concerning the method of performance of operations for reviews and opinions, the method of management and confidentiality of information that may come to their knowledge in the course of the performance of operations for reviews and opinions, and other methods for the appropriate performance of operations for reviews and opinions have been established; and

三前二号に掲げるもののほか、審査意見業務の適切な実施のために必要なものとして厚生労働省令で定める基準に適合するものであること。

(iii)in addition to those stated in the preceding two items, the clinical trials review board conforms to the standards specified by Order of the Ministry of Health, Labour and Welfare as being necessary for the appropriate performance of operations for reviews and opinions.

一認定を受けた者（以下「認定委員会設置者」という。）の氏名又は名称及び住所

(i)the name and address of a person who has obtained certification (referred to below as an "establisher of the certified board"); and

二認定に係る臨床研究審査委員会（以下「認定臨床研究審査委員会」という。）の名称

(ii)the name of the clinical trials review board concerning certification (referred to below as a "certified review board").

一申請者が、拘禁刑以上の刑に処せられ、その執行を終わり、又は執行を受けることがなくなるまでの者であるとき。

(i)if an applicant is a person who has been sentenced to imprisonment or a heavier punishment, and who has not yet finished serving the sentence or has not ceased to be subject to its enforcement;

二申請者が、この法律その他国民の保健医療に関する法律で政令で定めるものの規定により罰金の刑に処せられ、その執行を終わり、又は執行を受けることがなくなるまでの者であるとき。

(ii)if an applicant is a person who has been sentenced to a fine pursuant to the provisions of this Act or other laws concerning health and medical care for citizens as specified by Cabinet Order, and who has not yet finished serving the sentence or has not ceased to be subject to its enforcement;

三申請者が、第三十一条第一項の規定により前条第一項の認定を取り消され、その認定の取消しの日から起算して三年を経過しない者（認定の取消しの処分に係る行政手続法（平成五年法律第八十八号）第十五条第一項の規定による通知があった日（以下この条において「通知日」という。）前六十日以内に当該認定を取り消された法人の役員（いかなる名称によるかを問わず、これと同等以上の職権又は支配力を有する者を含む。以下この条において同じ。）であった者で当該認定の取消しの日から起算して三年を経過しないもの及び通知日前六十日以内に認定を取り消された団体の代表者又は管理人であった者で当該認定の取消しの日から起算して三年を経過しないものを含む。）であるとき。ただし、当該認定の取消しが、認定の取消しの処分の理由となった事実及び当該事実の発生を防止するための認定委員会設置者による体制の整備についての取組の状況その他の当該事実に関して当該認定委員会設置者が有していた責任の程度を考慮して、この号本文に規定する認定の取消しに該当しないこととすることが相当であると認められる認定の取消しとして厚生労働省令で定めるものに該当する場合を除く。

(iii)if an applicant is a person whose certification under paragraph (1) of the preceding Article has been rescinded pursuant to Article 31, paragraph (1), and for whom three years have not elapsed from the date of rescission of the certification (including a person who was an officer (including a person who has authority or control equivalent to or greater than that of the officer, irrespective of their title; the same applies below in this Article) of a corporation whose certification has been rescinded within sixty days before the day on which a notice concerning the disposition of rescission of certification was given under Article 15, paragraph (1) of the Administrative Procedure Act (Act No. 88 of 1993) (referred to below as the "notice day" in this Article) and for whom three years have not elapsed from the date of rescission of the certification, and a person who was the representative or administrator of an organization, certification of which has been rescinded within sixty days before the notice day and for whom three years have not elapsed from the date of rescission of the certification); provided, however, that this excludes the case where the rescission of certification falls under the rescission of certification specified by Order of the Ministry of Health, Labour and Welfare, such that it is found that it is appropriate to handle the case as one not falling under the rescission of certification provided for in the main clause of this item, taking into account the facts that constitute the grounds for the disposition of rescission of certification, the status of initiatives for the establishment of the system to prevent the occurrence of the facts by the establisher of the certified board, and the level of other responsibilities for the facts of the establisher of the certified board;

四申請者が、第三十一条第一項の規定による前条第一項の認定の取消しの処分に係る通知日から当該処分をする日又は処分をしないことを決定する日までの間に第二十七条第一項の規定による廃止の届出をした者（当該廃止について相当の理由がある者を除く。）で、当該届出の日から起算して三年を経過しないものであるとき。

(iv)if an applicant is a person who has filed a notification of abolition under Article 27, paragraph (1) in the period from the notice day concerning the disposition of rescission of certification under paragraph (1) of the preceding Article pursuant to Article 31, paragraph (1) to the day on which the disposition is rendered or it is decided that the disposition is not rendered (excluding a person who has reasonable grounds for the abolition), and for whom three years have not elapsed from the date of the notification;

五申請者が、前条第一項の認定の申請前三年以内に審査意見業務に関し不正又は著しく不当な行為をした者であるとき。

(v)if an applicant is a person who has committed a wrongful act or an extremely unjustifiable act concerning operations for reviews and opinions within three years before the filing of the application for certification under paragraph (1) of the preceding Article;

六申請者が、法人であって、その役員のうちに前各号のいずれかに該当する者があるとき。

(vi)if an applicant is a corporation and any of its officers falls under any of the preceding items; or

七申請者が、法人でない団体であって、その代表者又は管理人のうちに第一号から第五号までのいずれかに該当する者があるとき。

(vii)if an applicant is an organization without legal personality and its representative or administrator falls under any of items (i) through (v) of this Article.

一偽りその他不正の手段により第二十三条第一項の認定、第二十五条第一項の変更の認定又は第二十六条第二項の更新を受けたとき。

(i)if the establisher of the certified board has obtained certification under Article 23, paragraph (1), certification for changes under Article 25, paragraph (1), or renewal under Article 26, paragraph (2) through deception or other wrongful means;

二認定臨床研究審査委員会が第二十三条第四項各号に掲げる要件のいずれかに適合しなくなったとき。

(ii)if the certified review board ceases to conform to any of the requirements stated in the items of Article 23, paragraph (4);

三第二十四条各号（第三号及び第四号を除く。）のいずれかに該当するに至ったとき。

(iii)if the establisher of the certified board comes to fall under any of the items of Article 24 (excluding items (iii) and (iv));

四この章の規定又はこの章の規定に基づく命令に違反したとき。

(iv)if the establisher of the certified board has violated any provision of this Chapter or an order under any provision of this Chapter; or

五正当な理由がなくて第三十五条第一項の規定による報告若しくは物件の提出をせず、若しくは虚偽の報告若しくは虚偽の物件の提出をし、又は同項の規定による検査を拒み、妨げ、若しくは忌避し、若しくは同項の規定による質問に対し、答弁をせず、若しくは虚偽の答弁をしたとき。

(v)if the establisher of the certified board has failed to submit a report or any other item under Article 35, paragraph (1) without legitimate grounds or submitted a false report or item, has refused, obstructed, or evaded an inspection under that paragraph, or has failed to answer questions or made a false answer under that paragraph.

一第二条第一項の検査その他の行為を定める厚生労働省令又は同条第二項第二号ロ、ニ若しくはヘの厚生労働省令を制定し、又は改廃しようとするとき。

(i)establishing, amending, or repealing Order of the Ministry of Health, Labour and Welfare that specifies the examinations or other acts in Article 2, paragraph (1), or Order of the Ministry of Health, Labour and Welfare in item (ii), (b), (d), or (f) of paragraph (2) of that Article; or

二臨床研究実施基準を定め、又は変更しようとするとき。

(ii)establishing or changing the clinical trial standards.

一第五条第一項の規定に違反して、正当な理由がなくて実施計画を提出せず、又はこれに記載すべき事項を記載せず、若しくは虚偽の記載をしてこれを提出して、特定臨床研究を実施した者

(i)a person who has failed to submit a trial plan without legitimate grounds, or submitted a trial plan without stating the matters to be stated or containing a false statement, and implemented specified clinical trials in violation of the provisions of Article 5, paragraph (1);

二第六条第一項の規定に違反して、正当な理由がなくて実施計画を提出せず、又はこれに記載すべき事項を記載せず、若しくは虚偽の記載をしてこれを提出して、特定臨床研究を実施した者

(ii)a person who has failed to submit the trial plan without legitimate grounds, or submitted a trial plan without stating the matters to be stated or containing a false statement, and implemented specified clinical trials in violation of the provisions of Article 6, paragraph (1);

三第十二条の規定に違反して正当な理由がなくて記録の作成若しくは保存をしなかった者又は虚偽の記録を作成した者

(iii)a person who has failed to prepare or keep records without legitimate grounds, or prepared false records, in violation of the provisions of Article 12;

四第二十条第二項の規定による命令に違反した者

(iv)a person who has violated an order issued under Article 20, paragraph (2); or

五正当な理由がなくて第三十五条第一項の規定による報告若しくは物件の提出をせず、若しくは虚偽の報告若しくは虚偽の物件の提出をし、又は同項の規定による検査を拒み、妨げ、若しくは忌避し、若しくは同項の規定による質問に対し、答弁をせず、若しくは虚偽の答弁をした者

(v)a person who has failed to submit a report or any other item under Article 35, paragraph (1) without legitimate grounds, or submitted a false report or item, has refused, obstructed, or evaded an inspection under that paragraph, or has failed to answer questions under that paragraph or made a false answer.