[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR160.33]



[Page 146]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                  Subpart B_Organization and Personnel

 

Sec.  160.33  Study director.



    For each 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.  160.120 and is followed.

    (b) All experimental data, including observations of unanticipated 

responses of the test system are accurately recorded and verified.

    (c) Unforseen circumstances that may affect the quality and 

integrity of the 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.