[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: 21CFR58.120]
 
[Page 317]
 
                        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 G--Protocol for and Conduct of a Nonclinical Laboratory Study
 
Sec. 58.120  Protocol.
 
 
    (a) Each study shall have an approved written protocol that clearly
indicates the objectives and all methods for the conduct of the study.
The protocol shall contain, as applicable, the following information:
    (1) A descriptive title and statement of the purpose of the study.
    (2) Identification of the test and control articles by name,
chemical abstract number, or code number.
    (3) The name of the sponsor and the name and address of the testing
facility at which the study is being conducted.
    (4) The number, body weight range, sex, source of supply, species,
strain, substrain, and age of the test system.
    (5) The procedure for identification of the test system.
    (6) A description of the experimental design, including the methods
for the control of bias.
    (7) A description and/or identification of the diet used in the
study as well as solvents, emulsifiers, and/or other materials used to
solubilize or suspend the test or control articles before mixing with
the carrier. The description shall include specifications for acceptable
levels of contaminants that are reasonably expected to be present in the
dietary materials and are known to be capable of interfering with the
purpose or conduct of the study if present at levels greater than
established by the specifications.
    (8) Each dosage level, expressed in milligrams per kilogram of body
weight or other appropriate units, of the test or control article to be
administered and the method and frequency of administration.
    (9) The type and frequency of tests, analyses, and measurements to
be made.
    (10) The records to be maintained.
    (11) The date of approval of the protocol by the sponsor and the
dated signature of the study director.
    (12) A statement of the proposed statistical methods to be used.
    (b) All changes in or revisions of an approved protocol and the
reasons therefor shall be documented, signed by the study director,
dated, and maintained with the protocol.
 
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987;
67 FR 9585, Mar. 4, 2002]