[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: 21CFR58.120]



[Page 309-310]

 

                        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.



[[Page 310]]



    (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 therefore 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]