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

Chapter 5  Conduct and Report of the Study (Article 13 - Article 14)

In Japanese

(Conduct of the Study)
Article 13  In conducting the study, the following matters shall be strictly observed.

1) The study shall be carried out in compliance with the study protocol and standard operating procedures under the guidance and supervision of the study director.

2) The data shall be recorded with accurately legible and hardly erasable method, unless otherwise directly entered into the computer. In such event, the personnel who records the data shall state the date of recording the data, and sign and seal or affix signature to the record.

3) When the data is directly entered into a computer, the date of data entry and the personnel responsible for the entry shall be recorded.

4) The data shall be corrected in such a manner that enables the identification of the data prior to the correction, unless the data directly entered in a computer is corrected. In such event, the personnel who corrects the data shall state the date and reasons of correcting the data, and sign and seal or affix signature to the record.

5) When the data directly entered into a computer is corrected, the data shall be corrected in such a manner that enables the identification of data prior to the correction, and the reasons of the correction, the date, and the personnel responsible for the data entry shall be recorded.

6) On the specimens the symbol or No. that can identify the kind of studies and the test system by an appropriate method as well as the sampling date shall be indicated.

7) On containers containing reagents necessary for carrying out studies (including test and control substances. Hereinafter in this paragraph, this same principle applies) and reagents treated for studies, such as being dissolved in a suitable solvent, etc. (hereinafter in this article, called the "reagents, etc."), the name of the reagent shall be indicated and as required concentration, storage conditions, and expiration date, in order to prevent misuse.

8) Deteriorated or outdated reagents etc. shall not be used.

9) Should any abnormality occur during studies or any unforeseeable phenomenon occur, this shall immediately be reported to the study director and be recorded in detail.

10) When studies are carried out using animals, animals that contract or exhibit symptoms of diseases that would influence execution of the study shall be isolated from other animals and shall not be used in the studies.

(Final Report)
Article 14  The final report shall be prepared for each study.
2 The final report shall include the following matters.

1) Title and purpose of the study

2) Name and address of the sponsor for studies performed under contract

3) Name and address of the test facility, etc.

4) Name and post of the study director and the personnel

5) Date of starting the study and the date of finishing the study

6) Name, purity, composition, and physicochemical properties of the test substance and control substance

7) Test method adopted

8) Methods and frequency of observation, measurement, examination, and analysis

9) Statistical technique used for data analysis

10) Test results and discussions on the relevant results, and summary of these

11) Factors assumed to have influenced the quality of the study

12) Information on storage of records, samples, and materials

13) Date of preparing the final report

14) Matters necessary for properly evaluating the study results in addition to those mentioned in each of the preceding item
3 To the final report, the document prepared by the person responsible for the quality assurance pursuant to the provisions of Item 8 of Article 5 shall be attached.

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