(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

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

(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);

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

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

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

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

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

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

(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

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

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

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

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

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

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

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

(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;

(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

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

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

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

(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;

(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;

(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

(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.

(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);

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

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

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

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

(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;

(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

(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.

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

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

(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;

(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;

(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;

(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;

(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;

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

(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.

(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;

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

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

(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

(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.

(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

(ii)establishing or changing the clinical trial standards.

(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);

(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);

(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;

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

(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.