[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.185]
 
[Page 318]
 
                        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.
    (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]