Title Page
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Prepared on
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Prepared by
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Name of Research Laboratory
Protocol
Information Concerning the Sponsor and the Test Facility
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Name of test facility/test site involved
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Address of test facility/test site involved
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Name of Study Director
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Address of Study Director
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Name of the Sponsor
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Address of the Sponsor
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Name of Principal Investigator
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Address of Principal Investigator
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Phases of the study delegated by the Study Director and under the responsibility of the Principal Investigator
Identification of the Study, the Test Item and Reference Item
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A descriptive title
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A statement which reveals the nature and purpose of the study
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Identification of the test item by code or name (IUPAC; CAS number, biological parameters, etc.)
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Reference item to be used
Test Methods
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Justification for selection of the test system
Characterization of the test system
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General description
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Species
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Strain
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Substrain
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Source of supply
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Number
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Body weight range
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Sex
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Age
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Type of cage
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Diet and its source
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How the test system will be identified
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Other pertinent information:
Administration
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Method of administration
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Reason for the choice of method of administration
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Dose levels and/or concentrations(s)
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Method of preparation of the dose concentrations
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Dosing route
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Vehicles used
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Frequency
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Duration
Experimental design
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Description of the chronological procedure of the study
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Methods (including those for the control of bias)
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Materials and conditions
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Type and frequency of analysis
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Measurements
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Observations and examinations to be performed
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Statistical methods to be used (if any)
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List of records to be retained:
Dates
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Date of approval of the protocol by signature of the Study Director
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Signature of Study Director
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Date of approval of the protocol by signature of the Test Facility Manager
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Signature of Test Facility Manager
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The proposed experimental starting date
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The proposed experimental completion date
