[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: 21CFR58.33]



[Page 305]

 

                        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]