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Guideline

Standard to be satisfied by test facilities, etc. conducting toxicity investigation

Chapter 2  Organization (Article 3 - Article 7)

In Japanese
(Management)
Article 3  For the test facilities, etc., management shall be stationed to carry out the following matters.

1) For each study and before starting the study concerned, to nominate a study director among people with sufficient knowledge and experience on the study concerned.

2) For each study, to allocate sufficient number of people engaged in the study (hereinafter called the "personnel") for performing the study concerned properly and opportunely among people who have received necessary education or training for pursuing the study concerned or who have sufficient job experience.

3) To make sure that the personnel clearly understand the duties and if necessary, to provide education or training to the personnel.

4) To prepare records concerning education, training and job experience and documents to clearly indicate division of duties of the personnel.

5) For each study and before starting the study concerned, to nominate a person responsible for quality assurance among people who have sufficient knowledge and experience on the study concerned (excluding the personnel engaged in the study concerned). However, when the matters provided in Article 5 are carried out by the person responsible for quality assurance nominated by the study sponsor, etc. with respect to the study concerned, the relevant nomination may be substituted by confirming that person responsible for quality assurance.

6) To make sure that all deviations from the standard provided in this notification notified by the person responsible for quality assurance are transmitted to the study director and corrective actions are taken against the relevant deviations by the study director, and the results are recorded.

7) To prepare a quality assurance program.

8) To nominate a person responsible for the archives.

9) To prepare and distribute the standard operating procedures.

10) To prepare the master schedule sheet.

11) To approve the study protocol.

12) To take measures for safety and health of the personnel.

13) Matters necessary for proper conduct of the study in addition to those set forth in the preceding items.
2 The management shall be the person who supervises and controls the operation in the relevant test facility, etc.
(Study Director)
Article 4  The study director shall carry out the following with respect to the study related to the nomination.

1) Before starting the study, to prepare the study protocol, to sign and seal or affix signature, and to receive the approval of the management (in the case the study is carried out by commissioning, the sponsor, etc. is included. This applies hereinafter in this article.), to state the date of approval, and to submit the copy of the study protocol related to the approval to the person responsible for quality assurance.

2) When the study protocol is amended, to obtain approval of the management as well as to prepare a document that carries the date of the amendment and the contents of and the reasons for the amendment, and to submit the copy of the relevant document to the person responsible for quality assurance.

3) To carry out the study in conformity to the study protocol and standard operating procedures.

4) When a computer system is used for the study, to make sure that the relevant computer system operates properly in advance.

5) To record all the data obtained with respect to the study and the progress of the study.

6) To prepare the final report and to sign and seal or to affix signature to the report.

7) If the final report must be corrected, prepare the document in which the date of the correction and the contents of and reasons for the correction are stated, and to sign and seal or to affix signature to the document.

8) To give instructions to the personnel with respect to safety and health, to grasp the personnel's health condition, and to take necessary measures as required.

9) To take necessary corrective actions against the deviations from the study protocol or standard operating procedures, and to record the results.

10) Upon completion of the study, to transfer the study protocol, final report, specimens, raw data, and other necessary records, samples, and materials to the archives.

11) In addition to the matters recited in each of the preceding items, matters necessary for proper conduct of the study.
(Person Responsible for Quality Assurance)
Article 5  The person responsible for quality assurance shall carry out the following with respect to the study related to the nomination.

1) To retain copies of the master schedule sheet, study protocols, and standard operating procedures.

2) To make sure that the matters set forth in each of the items of Paragraph 2 of Article 11 are included in the study protocol.

3) To carry out audits and inspections periodically or whenever necessary according to the nature of the study, in accordance with the quality assurance program, in order to make sure that the study is being carried out in compliance with the study protocol and the standard operating procedures and the study results precisely reflect the raw data.

4) When audits or inspections were carried out, to prepare a report that states the date of audit or inspection executed as well as the findings and submit the copy to the management and the study director each time.

5) If any deviation from the study protocol or any deviation from the standard operating procedures are found as a result of the audit or the inspection, to immediately report to the management and the study director and at the same time to record the contents.

6) To make sure that the corrective actions by the study director as provided in Item 9 of preceding Article are properly implemented.

7) To audit the final report. In such event, to make sure that the study method is accurately stated, and the contents of the final report precisely reflect the raw data.

8) To prepare a document that states the date of audit or inspection executed, and the date when the contents and the findings are reported to the management and the study director, and to sign and seal or to affix the signature.
(Personnel)
Article 6  The personnel shall abide by the following.

1) To take necessary care to prevent contamination of the test substance, control substance, and the test system.

2) To quickly and accurately record the raw data.

3) When any deviation from the study protocol or standard operating procedures is found, to report to the study director and to record the contents.

4) To take sufficient care to the safety and health.

5) The personnel who contracts a disease that would influence the execution of the study shall report to the study director of this and receive his/her directions.
(Person responsible for the archives)
Article 7  The person responsible for the archives shall execute the duty to store the following items.

1) Master schedule sheet

2) Study protocol

3) Final report

4) Raw data

5) Reports or records prepared by the person responsible for quality assurance pursuant to the provisions of Item 4 or Item 5 of Article 5

6) Standard operating procedures

7) Records and documents prepared by the management pursuant to the provisions of Item 4, Paragraph 1, Article 3

8) Records prepared pursuant to the provisions of Item 2, Paragraph 4, Article 9

9) Samples of test substance, etc.

10) Specimens

11) In addition to those set forth in each of the preceding items, records, etc. necessary for evaluation of the study
INDEX
Chapter 1 / Chapter 2 / Chapter 3 / Chapter 4 / Chapter 5 / Chapter 6 / Chapter 7
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