Title Page

  • Prepared on

  • Prepared by

  • Name of Research Laboratory


Information Concerning the Sponsor and the Test Facility

  • Name of test facility/test site involved

  • Address of test facility/test site involved
  • Name of Study Director

  • Address of Study Director
  • Name of the Sponsor

  • Address of the Sponsor
  • Name of Principal Investigator

  • Address of Principal Investigator
  • 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

  • A descriptive title

  • A statement which reveals the nature and purpose of the study

  • Identification of the test item by code or name (IUPAC; CAS number, biological parameters, etc.)

  • Reference item to be used

Test Methods

  • Justification for selection of the test system

Characterization of the test system

  • General description

  • Species

  • Strain

  • Substrain

  • Source of supply

  • Number

  • Body weight range

  • Sex

  • Age

  • Type of cage

  • Diet and its source

  • How the test system will be identified

  • Other pertinent information:


  • Method of administration

  • Reason for the choice of method of administration

  • Dose levels and/or concentrations(s)

  • Method of preparation of the dose concentrations

  • Dosing route

  • Vehicles used

  • Frequency

  • Duration

Experimental design

  • Description of the chronological procedure of the study

  • Methods (including those for the control of bias)

  • Materials and conditions

  • Type and frequency of analysis

  • Measurements

  • Observations and examinations to be performed

  • Statistical methods to be used (if any)

  • List of records to be retained:


  • Date of approval of the protocol by signature of the Study Director

  • Signature of Study Director

  • Date of approval of the protocol by signature of the Test Facility Manager

  • Signature of Test Facility Manager

  • The proposed experimental starting date

  • The proposed experimental completion date

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