[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.33]

[Page 334]
 
                        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 B_Organization and Personnel
 
Sec. 58.33  Study director.

    For each nonclinical laboratory study, a scientist or other 
professional of appropriate education, training, and experience, or 
combination thereof, shall be identified as the study director. The 
study director has overall responsibility for the technical conduct of 
the study, as well as for the interpretation, analysis, documentation 
and reporting of results, and represents the single point of study 
control. The study director shall assure that:
    (a) The protocol, including any change, is approved as provided by 
Sec. 58.120 and is followed.
    (b) All experimental data, including observations of unanticipated 
responses of the test system are accurately recorded and verified.
    (c) Unforeseen circumstances that may affect the quality and 
integrity of the nonclinical laboratory study are noted when they occur, 
and corrective action is taken and documented.
    (d) Test systems are as specified in the protocol.
    (e) All applicable good laboratory practice regulations are 
followed.
    (f) All raw data, documentation, protocols, specimens, and final 
reports are transferred to the archives during or at the close of the 
study.

[43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar. 23, 1979]