JICOSH Home >
Guidelines >
Report on Results of Chromosome Aberration Test using Cultured Mammalian Cells
| Standard to be satisfied by test facilities, etc. conducting toxicity investigation
Chapter 4 Standard Operating Procedures, Etc. (Article 10 - Article 12) In Japanese |
||||||||||||||||||||||||||||||
(Standard operating procedures) |
||||||||||||||||||||||||||||||
| Article 10 The following shall be included in the standard operating procedure: | ||||||||||||||||||||||||||||||
| 1) | Matters related to receipt, storage, and handling of the test substance and control substance. | |||||||||||||||||||||||||||||
| 2) | Matters related to operation, inspection, and maintenance of the equipment. | |||||||||||||||||||||||||||||
| 3) | Matters related to handling of the test system. | |||||||||||||||||||||||||||||
| 4) | Matters related to care and management of experimental animals. | |||||||||||||||||||||||||||||
| 5) | Matters related to preparation, storage, and identification of reagents. | |||||||||||||||||||||||||||||
| 6) | Matters related to observation, measurement, inspection, and analysis. | |||||||||||||||||||||||||||||
| 7) | Matters related to data handling, storage, and retrieval. | |||||||||||||||||||||||||||||
| 8) | Matters related to confirmation of performance of the computer system. | |||||||||||||||||||||||||||||
| 9) | Matters related to safety and health. | |||||||||||||||||||||||||||||
| 10) | Matters related to wastes disposal. | |||||||||||||||||||||||||||||
| 11) | Matters necessary for execution of the study in addition to those mentioned in each of the preceding items. | |||||||||||||||||||||||||||||
| 2 | The standard operating procedures shall be made available in each area where the study related to the standard operating procedures is implemented. |
|||||||||||||||||||||||||||||
| (Study Protocol) | ||||||||||||||||||||||||||||||
| Article 11 The study protocol shall be prepared for each study before starting the study concerned. | ||||||||||||||||||||||||||||||
| 2 | The following shall be included in the study protocol: | |||||||||||||||||||||||||||||
| 1) | Title and purpose of the study | |||||||||||||||||||||||||||||
| 2) | Name and address of the test facility, etc. | |||||||||||||||||||||||||||||
| 3) | Name and address of the sponsor for studies performed under contact | |||||||||||||||||||||||||||||
| 4) | Name and post of the study director | |||||||||||||||||||||||||||||
| 5) | Date scheduled to start the study and the study period | |||||||||||||||||||||||||||||
| 6) | Name, purity, composition, and physicochemical properties of the test substance and the control substance | |||||||||||||||||||||||||||||
| 7) | Test methods adopted | |||||||||||||||||||||||||||||
| 8) | Environmental conditions of the test system | |||||||||||||||||||||||||||||
| 9) | Observation, measurement, inspection, and analysis methods and frequency | |||||||||||||||||||||||||||||
| 10) | Solvent or emulsifier used for dissolving or suspending the test and control substances (if the test substance is gas, the gas used for diluting) | |||||||||||||||||||||||||||||
| 11) | Statistical technique used for data analysis | |||||||||||||||||||||||||||||
| 12) | Method for storing records, samples, and materials | |||||||||||||||||||||||||||||
| 13) | Matters necessary for implementing the study in addition to those mentioned
in each of the preceding items |
|||||||||||||||||||||||||||||
| (Quality Assurance Program) | ||||||||||||||||||||||||||||||
| Article 12 The matters to be stated in the quality assurance program shall include the following: | ||||||||||||||||||||||||||||||
| 1) | Matters related to the study audit and inspection. | |||||||||||||||||||||||||||||
| 2) | Matters related to the inspection of facilities for implementing the study. | |||||||||||||||||||||||||||||
| 3) | Matters related to the audit of the final report. | |||||||||||||||||||||||||||||
| 4) | Matters necessary for implementing duties related to quality assurance
in addition to those mentioned in each of the preceding items |
|||||||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
top- Home |
- Sitemap |
- Disclaimer
Copyright (C) 1999- JICOSH All Right Reserved.