Chapter III. Section 2. Standards for Clinical Trial Management by Sponsor-investigator (Articles 26-2 through 26-12)

Aricle 26-2. Investigational Product Control/Accountability

1. The sponsor-investigator shall indicate the following information on the container or package of the investigational products in the Japanese language:
(1) Statement of “For clinical trial use only”
(2) Name, title, and address of the sponsor-investigator
(3) Chemical name or identification code
(4) Manufacturing number or manufacturing code
(5) Information on storage method, expiration date, etc., if necessary

2. The sponsor-investigator shall not indicate the following information in the documents attached to the investigational products, on the investigational products, or on their containers or packages (including the inner packages):
(1) Proposed brand name
(2) Proposed indications
(3) Proposed administration and dosage

3. When investigational products are supplied to the medical institutions in such a state that the subject, subinvestigator, and clinical research coordinators cannot distinguish the test drug from the comparator, the sponsor-investigator shall take necessary measures so that the subinvestigator can readily identify the test drug from the comparator in the event of an emergency.

4. The sponsor-investigator shall take necessary measures to prevent contamination and deterioration of the investigational products during transport and storage.

5. The sponsor-investigator shall prepare or obtain the following records concerning the investigational products:

(1) Records concerning the manufacture of the investigational products, such as the manufacturing date, manufacturing method and manufactured quantity, and the results of the tests on the product's quality, such as its stability

(2) Records of the quantity and the date of obtaining or receiving the investigational products when sponsor-investigator obtains the investigational products, or receives them from the investigational product provider

(3) Records of disposal of the investigational products

6. The sponsor-investigator shall prepare written operating procedures for investigational product control/accountability at the medical institution and deliver the procedures to the medical institution without delay after the conduct of the clinical trial is approved by the head of the medical institution.

7. The sponsor-investigator shall prepare, as necessary, documents explaining the reconstitution procedures and other handling procedures for the investigational products and deliver the documents to the subinvestigator, clinical research coordinators, and the investigational product storage managers specified in Article 39.

Article 26-3. Ensuring Quality of Investigational Products

The sponsor-investigator shall conduct the clinical trial by using investigational products that have been manufactured at a manufacturing site furnished with adequate buildings and facilities to ensure the quality of the investigational products. Thew manufacturing site shall also have appropriate manufacturing control and quality control systems in place.

Article 26-4. Preparing Description of Assignment

When the sponsor-investigator assigns the duties of coordination as specified in Article 2, Paragraph 16 to a coordinating investigator or a coordinating committee , the sponsor-investigator shall prepare a document describing the scope of the duties, the operating procedures and other necessary details.

Article 26-5. Establishment of Efficacy and Safety Assessment Committee

1. A sponsor-investigator may establish an Efficacy and Safety Assessment Committee
that deliberates the appropriateness of continuing an ongoing clinical trial, or the
revision of the protocol.
2. The sponsor-investigator shall prepare written operating procedures for the deliberation
by the Efficacy and Safety Assessment Committee specified in the preceding paragraph
and have the committee conduct deliberation in compliance with the procedures.
3. The sponsor-investigator shall prepare and retain records of the deliberation of the
committee whenever the deliberation specified in the preceding paragraph is held.

Article 26-6. Information on Adverse Drug Reactions etc.

1. The sponsor-investigator shall collect and examine information necessary to conduct the clinical trial properly, such as information on the quality, efficacy, and safety of the test drug, and provide the head of the medical institution with such information.

2. Whenever the sponsor-investigator becomes aware of any events concerning the test drug that are specified in Article 80-2, Paragraph 6 of PAA, the sponsor-investigator shall immediately notify the head of the medical institution of the fact (if the clinical trial is jointly conducted at more than one medical institution according to a single protocol, then including the investigators of the other medical institutions).

3. Whenever the sponsor-investigator becomes aware of any information relevant to the proper conduct of the clinical trial, such as information on the quality, efficacy, and safety of the test drug, the sponsor-investigator shall revise the protocol and the Investigator’s Brochure, as necessary.

Article 26-7. Monitoring

1. The sponsor-investigator shall prepare written operating procedures for monitoring, and have the monitor conduct monitoring activities in compliance with the procedures, taking into account the opinions of the IRB as specified in Article 27, Paragraph 1.
2. The monitor shall not engage in the clinical trial at the medical institution to be monitored.
3. Monitoring pursuant to Paragraph 1 shall be conducted by visiting the medical institution, except when monitoring is adequately performed by other means.

Article 26-8. Monitor's Responsibilities

1. If the monitor has found, as a result of monitoring, that the clinical trial is not being conducted at a medical institution in compliance with this Ministerial Ordinance or the protocol, the monitor shall immediately notify the investigator of the medical institution of the fact.

2. The monitor shall submit a monitoring report documenting the following information to the sponsor-investigator and the head of the monitored medical institution after each site visit:
(1) Date of monitoring
(2) Name of the monitor
(3) Name of the investigators etc. interviewed during the monitoring visit
(4) Summary of the results of the monitoring
(5) Description of the fact of which the monitor notified the investigator pursuant to the preceding paragraph
(6) Actions to be taken concerning the matters specified in the preceding item and the monitor's comments on such actions

Article 26-9. Audit

1. The sponsor-investigator shall prepare an audit plan and written operating procedures for the related duties, and have auditors conduct audits in accordance with the audit plan and the operating procedures, taking into account the opinion of the IRB as specified in Article 27, Paragraph 1.

2. The auditors shall not engage in the clinical trial (including its preparation and management) and monitoring at the medical institution to be audited.

3. The auditors shall prepare an audit report documenting the findings in the audit and an audit certificate verifying that the audit has been conducted, and submit them to the sponsor-investigator and the head of the medical institution.

Article 26-10. Premature Termination etc. of Clinical Trial

1. If it is found that a medical institution has violated this Ministerial Ordinance or the protocol, resulting in interference with the proper conduct of the clinical trial (excluding the cases specified in Article 46), the sponsor-investigator shall prematurely terminate the clinical trial at the medical institution.

2. If the clinical trial is suspended or prematurely terminated, the sponsor-investigator shall promptly notify in writing the head(s) of the medical institution(s) of the suspension or premature termination and the reasons thereof.

 3. If the sponsor-investigator is informed that the clinical data obtained in the clinical trial will not be submitted in the application specified in Article 14, Paragraph 3 of PAA, the sponsor-investigator shall notify in writing the head(s) of the medical institution(s) of the fact and the reason thereof.

Article 26-11. Clinical Trial Reports

The sponsor-investigator shall prepare the clinical trial reports when the clinical trial is completed or prematurely terminated.

Article 26-12. Record Keeping etc.

The sponsor-investigator shall appropriately retain the following records (including documents and data) related to the clinical trial until the day on which the investigational product provider receives marketing approval of the test drug (or the day 3 years after the date of notification in the case of a notification pursuant to 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) Protocol, Approval Document, clinical trial reports, and other documents prepared by the sponsor-investigator in accordance with this Ministerial Ordinance, or copies thereof
(2) Case report forms, the written notification pursuant to Article 32, Paragraph 7, and other records obtained from the head of medical institution or subinvestigators
(3) Records of the duties related to the standards for conducting the clinical trial and the management of the clinical trial, such as monitoring and audits (excluding those specified in the preceding two items and Item (5))
(4) Data generated in conducting the clinical trial
(5) Records specified in Article 26-2, Paragraph 5

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

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