Chapter IV. Standards for Conducting Clinical Trials. Section 2.

Medical Institution: 'Ministerial Ordinance on Good Clinical Practice for Drugs', PMDA Japan

Article 35. Qualifications for Medical Institution

The medical institution shall meet the following qualifications:
(1) Being well equipped with facilities and having sufficient personnel to conduct the necessary clinical observations and laboratory tests.
(2) Being capable of taking necessary measures for the subject in the event of an emergency.
(3) Having investigators etc., pharmacists, nurses and other adequate personnel for the proper and smooth conduct of the clinical trial.

Article 36. Head of Medical Institution

1. The head of the medical institution shall prepare written operating procedures for the duties related to the clinical trial.

2. The head of the medical institution shall take necessary measures to ensure that the clinical trial is conducted properly and smoothly at the medical institution in compliance with this Ministerial Ordinance, the protocol, and the clinical trial contract in the case of a sponsor-initiated clinical trial, or the documents stipulated in Article 15-7, Items (5) though (11), in the case of an investigator-initiated clinical trial, as well as the procedures as stipulated in the preceding paragraph.

3. The head of the medical institution shall take necessary measures to ensure that confidentiality of subjects is protected.

Article 37. Cooperation for Monitoring

1. The head of the medical institution shall cooperate for the monitoring and audit conducted by the sponsor or outsourced by the sponsor-investigator, as well as the reviews by the IRB stipulated in Article 27, Paragraph 1 and the expert IRB (the expert IRB becomes involved in the reviews only when the head of the medical institution seeks the opinion of the expert IRB pursuant to Article 30, Paragraph 4; hereinafter collectively referred to as “IRB etc”).

2. When the monitoring, audit, or review as stipulated in the preceding paragraph is conducted, the head of the medical institution shall provide direct access to the records of the clinical trial as stipulated in Article 41, Paragraph 2, upon the request of the monitor, auditor, or the IRB etc.

Article 38. Clinical Trial Office

The head of the medical institution shall appoint a person or persons who perform clerical work concerning trial-related duties.

Article 39. Investigational Product Control/Accountability

The investigational product storage manager (which refers to the person who is responsible for investigational product control/accountability) shall properly conduct the duties of investigational product control/accountability in compliance with the operating procedures as stipulated in Article 16, Paragraph 6 or Article 26-2, Paragraph 6.

Article 39-2. Outsourcing Duties

The medical institution (the investigator or the medical institution, in the case of a investigator-initiated clinical trial; the same applies in this article) shall conclude a contract with a contractor by means of a document specifying the following information when outsourcing any of the duties related to the conduct of the clinical trial:

(1) Scope of the duties outsourced
(2)Description of the operating procedures for the duties outsourced
(3) Statement that the medical institution can ascertain whether the duties outsourced are conducted properly and smoothly in compliance with the operating procedures specified in the preceding item
(4)Description of the instructions to the contractor
(5) Statement that if the instructions specified in the preceding item are given, the medical institution is entitled to ascertain whether appropriate measures are taken in response to the instructions
(6)Description of the reports to be submitted by the contractor to the medical institution
(7) Other necessary matters related to the duties outsourced

Article 40. Premature Termination etc. of Clinical Trial

1. When notified by the sponsor pursuant to Article 20, Paragraphs 2 and 3 or by the sponsor-investigator pursuant to Article 26-6, Paragraph 2, the head of the medical institution shall immediately notify in writing the IRB etc. of the fact.

2. When notified by the sponsor pursuant to Article 24, Paragraph 2 or by the sponsor-investigator pursuant to Article 26-10, Paragraph 2, of suspension or premature termination of the clinical trial; when notified by the sponsor, pursuant to Article 24, Paragraph 3, that the sponsor has decided not to include the clinical trial data in the application; or when notified by the sponsor-investigator, pursuant to Article 26-10, Paragraph 3, that the sponsor-investigator has been informed that the clinical trial data
will not be included in the application, the head of the medical institution shall promptly notify in writing the investigator and the IRB etc. of the fact and the reason thereof.

3. When reported by the investigator that the clinical trial will be suspended or prematurely terminated by the investigator pursuant to Article 49, Paragraph 2, the head of the medical institution shall promptly notify in writing the IRB etc. and the sponsor of the fact and the reason thereof.

4. When reported by the investigator that the clinical trial has been completed pursuant to Article 49, Paragraph 3, the head of the medical institution shall notify the IRB etc. and the sponsor of the fact and a summary of the trial’s outcome.

5. The provisions of Article 10, Paragraphs 2 through 6 shall apply mutatis mutandis to the notification in writing as stipulated in Paragraph 3 of this article. In this case, "person who intends to sponsor a clinical trial" and "head of the medical institution" in these provisions shall be read as "head of the medical institution" and "sponsor," respectively.

Article 41. Record Keeping

1. The head of the medical institution shall appoint a record keeping manager.

2. The record keeping manager specified in the preceding paragraph shall retain the following records (including documents) until the day on which marketing approval of the test drug is obtained (or the day 3 years after the date of notification in the case of a notification pursuant to Article 24, Paragraph 3 or Article 26-10, Paragraph 3) or the day 3 years after the date of premature termination or completion of the clinical trial, whichever comes later:
(1) Source documents
(2) The contract or Approval Document, informed consent forms, written information and other documents prepared by persons engaged in the clinical trial at the medical institution in accordance with this Ministerial Ordinance, or their copies (3) The protocol, documents obtained from the IRB etc. pursuant to Article 32, Paragraphs 1 through 3, and other documents obtained in accordance with this Ministerial Ordinance
(4) Records of trial-related duties such as control/accountability of investigational products

'Ministerial Ordinance on Good Clinical Practice for Drugs', source: Pharmaceuticals and Medical Devices Agency, Japan

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