[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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

[CITE: 21CFR58.185]



[Page 310-311]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 58_GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

--Table of Contents

 

                      Subpart J_Records and Reports

 

Sec.  58.185  Reporting of nonclinical laboratory study results.





    (a) A final report shall be prepared for each nonclinical laboratory 

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 completed.

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

including any changes in the original protocol.

    (3) Statistical methods employed for analyzing the data.

    (4) The test and control articles identified by name, chemical 

abstracts number or code number, strength, purity, and composition or 

other appropriate characteristics.



[[Page 311]]



    (5) Stability of the test and control articles 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 cirmcumstances 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.

    (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.  58.35(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.



[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987]