Chapter IV. Standards for Conducting Clinical Trials. Section 3.

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

Article 42. Qualifications for Investigator

An investigator shall meet the following qualifications:
(1) Being fully qualified by education, training, and adequate clinical experience to assume responsibility for the proper conduct of the clinical trial.
(2) Being well versed in the appropriate administration of the investigational products specified in the protocol, the Investigator’s Brochure, and the document specified in Article 16, Paragraph 7 or Article 26-2, Paragraph 7.
(3) Having sufficient time to conduct the clinical trial.

Article 43. Subinvestigators etc.

1. When the clinical trial is conducted with involvement of subinvestigators or clinical research coordinators, the investigator shall prepare a list of the duties assigned to them.

2. The investigator shall fully explain the duties of the clinical trial to the subinvestigators and clinical research coordinators and provide them with the information notified pursuant to Article 20, Paragraphs 2 and 3, the information notified pursuant to Article 26-6, Paragraph 2, and other information necessary for the proper and smooth conduct of the assigned duties.

Article 44. Selection of Subjects

The investigators etc. shall select prospective subjects, taking into account the following principles:
(1) The prospective subject's health condition, symptoms, age, ability to give consent, etc. shall be carefully considered, in line with the objectives of the clinical trial, from ethical and scientific viewpoints.
(2) Any prospective subject who is incapable of giving consent shall not be selected unless it is inevitable to enroll him or her in the clinical trial.
(3) In selecting a subject who may unduly incur any disadvantage if the subject refuses to participate in the clinical trial, careful considerations shall be given so that he or she can voluntarily give consent to his or her participation.

Article 45. Responsibilities for Medical Care of Subjects
 

1. The investigators etc. shall explain the appropriate use of the investigational products to each subject and, as necessary, check whether each subject is properly using the investigational products.

2. If a subject is receiving treatment by another primary physician, the investigators etc. shall inform the primary physician, with prior consent of the subject, that the subject will participate in the clinical trial.

3. The head of the medical institution and the investigators etc. shall beforehand take necessary measures to ensure that adequate medical care is provided to a subject for any adverse event.

4. The investigators etc. shall inform a subject of the fact that medical care is needed for adverse event(s) of which the investigator becomes aware, if applicable.

Article 46. Deviations from Protocol

1. When the investigator has failed to comply with the protocol in order to eliminate immediate hazards to subjects or for other inevitable medical reasons, the investigator shall document all such deviations, and immediately submit the document describing those deviations and the reasons thereof to the sponsor and the head of the medical institution in the case of a sponsor-initiated clinical trial, or submit to the head of the medical institution in the case of a investigator-initiated clinical trial.

2. The provisions of Article 10, Paragraphs 2 through 6 shall  apply mutatis mutandis to the submission of documents as stipulated in the preceding paragraph in the case of a sponsor-initiated clinical trial. In this case, "person who intends to sponsor a clinical trial" and "head of the medical institution" in these provisions shall be read as "investigator" and "sponsor," respectively.

Article 47. Case Report Form (CRF) etc.

1. The investigators etc. shall prepare CRFs accurately in compliance with the protocol, and shall affix the name(s) and seal, or sign the forms.

2. Any changes or corrections made to a CRF shall be dated and affixed with the seal, or signed by the investigators etc.

3. The investigator shall inspect the CRFs prepared by the subinvestigator(s) and confirm the content thereof to affix the name and seal, or sign the forms.

Article 48. Reporting of Adverse Drug Reactions that Occurred during Clinical Trial

1. The investigator shall submit a written summary of the clinical trial status to the head of the medical institution, as appropriate.

2. In the case of a sponsor-initiated clinical trial, if the investigator becomes aware of death or any serious adverse event suspected to be attributable to adverse reactions to the investigational product, the investigator shall immediately report the fact to the head of the medical institution and notify the sponsor of the fact. In such cases, the investigator shall provide additional relevant information upon the request of the sponsor, the head
of the medical institution, or the IRB etc.

3. In the case of an investigator-initiated clinical trial, if the investigator becomes aware of death or any serious adverse event suspected to be attributable to adverse reactions to the investigational product, the investigator shall immediately report the fact to the head of the medical institution (if the clinical trial is conducted jointly at more than one medical institution according to a single protocol, then including the investigators of the other medical institutions) and notify the investigational product provider of the fact. In such cases, the investigator shall provide additional relevant information upon the request of the investigational product provider, the head(s) of the medical institution(s), or the IRB etc.

Article 49. Premature Termination etc. of Clinical Trial

1. If the clinical trial is suspended or prematurely terminated in accordance with the notification pursuant to Article 40, Paragraph 2, the investigator shall promptly notify the subjects of the fact, and shall provide appropriate medical care to the subjects and take other necessary measures.

2. If the investigator suspends or prematurely terminates a clinical trial at his or her discretion, the investigator shall promptly report the fact and the reason thereof in writing to the head of the medical institution.

3. Upon completion of a clinical trial, the investigator shall report the completion in writing and submit a written summary of the trial’s outcome to the head of the medical institution.

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

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