Good Laboratory Practice (GLP) Report Template

• Prepared on

  Date

• 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
  Address

• Name of Study Director

• Address of Study Director
  Address

• Name of the Sponsor

• Address of the Sponsor
  Address

• Name of Principal Investigator

• Address of Principal Investigator
  Address

• Phases of the study delegated

Information on scientists having contributed reports to the Final Report:

Scientist

• Name

• Address
  Address

• Report contributed

• Signature to verify report

  Sign

• Date report was prepared

  Date

Dates

• Experimental starting date

  Date

• Experimental completion date

  Date

Identification of the Study, the Test Item and Reference Item

• Descriptive title of the study

• Study objectives

• Procedures stated in the approved protocol

• Any changes in the original protocol

• Deviations from the approved protocol

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

• Characterization of the test item including strength, purity, stability, composition and homogeneity

• Identification of the reference item by name

Description of Materials and Test Methods

• Description of methods and materials used

• Reference to OECD Test Guideline or other test guideline or method

• Description of test system

• Details of dosing, route and duration

Results

• A summary of results

All information and data required by the study plan/protocol:

Text
Media

• Add media

  Media

• Description of all circumstances that may have affected the quality or integrity of the data

A presentation of the results, including calculations and determinations of statistical significance:

Text
Media

• Add media

  Media

An evaluation and discussion of results and, where appropriate, conclusions:

Text
Media

• Add media

  Media

Storage

• Location where the Study Plan or Protocol is to be stored

• Location where samples of test and reference items are to be stored

• Location where specimens are to be stored

• Location where raw data are to be stored

• Location where the Final Report is to be stored

Statements

• Indicate acceptance of responsibility for the validity of data and the extent to which the study complies with the Principles of Good Laboratory Practice.

• GLP Compliance Statement

• Signature of Study Director

  Sign

• List the types of inspections made and their dates, the phase(s) inspected, and the dates any inspection results were reported to management and to the Study Director and Principal Investigator, if applicable. Confirm that the Final Report reflects the raw data.

• Quality Assurance Statement

• Signature of Quality Assurance Unit

  Sign