[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR160.185]



[Page 152-153]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                      Subpart J_Records and Reports

 

Sec. 160.185  Reporting of study results.





    (a) A final report shall be prepared for each study and shall 

include, but not necessarily be limited to, the following:

    (1) Name and address of the facility performing the study and the 

dates on which the study was initiated and was completed, terminated, or 

discontinued.

    (2) Objectives and procedures stated in the approved protocol, 

including any changes in the original protocol.

    (3) Statistical methods employed for analyzing the data.



[[Page 153]]



    (4) The test, control, and reference substances identified by name, 

chemical abstracts service (CAS) number or code number, strength, 

purity, and composition, or other appropriate characteristics.

    (5) Stability and, when relevant to the conduct of the study the 

solubility of the test, control, and reference substances under the 

conditions of administration.

    (6) A description of the methods used.

    (7) A description of the test system used. Where applicable, the 

final report shall include the number of animals used, sex, body weight 

range, source of supply, species, strain and substrain, age, and 

procedure used for identification.

    (8) A description of the dosage, dosage regimen, route of 

administration, and duration.

    (9) A description of all circumstances that may have affected the 

quality or integrity of the data.

    (10) The name of the study director, the names of other scientists 

or professionals and the names of all supervisory personnel, involved in 

the study.

    (11) A description of the transformations, calculations, or 

operations performed on the data, a summary and analysis of the data, 

and a statement of the conclusions drawn from the analysis.

    (12) The signed and dated reports of each of the individual 

scientists or other professionals involved in the study, including each 

person who, at the request or direction of the testing facility or 

sponsor, conducted an analysis or evaluation of data or specimens from 

the study after data generation was completed.

    (13) The locations where all specimens, raw data, and the final 

report are to be stored.

    (14) The statement prepared and signed by the quality assurance unit 

as described in Sec. 160.35(b)(7).

    (b) The final report shall be signed and dated by the study 

director.

    (c) Corrections or additions to a final report shall be in the form 

of an amendment by the study director. The amendment shall clearly 

identify that part of the final report that is being added to or 

corrected and the reasons for the correction or addition, and shall be 

signed and dated by the person responsible. Modification of a final 

report to comply with the submission requirements of EPA does not 

constitute a correction, addition, or amendment to a final report.

    (d) A copy of the final report and of any amendment to it shall be 

maintained by the sponsor and the test facility.