[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2005]

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

[CITE: 40CFR160.130]



[Page 152]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

              Subpart G_Protocol for and Conduct of a Study

 

Sec. 160.130  Conduct of a study.



    (a) The study shall be conducted in accordance with the protocol.

    (b) The test systems shall be monitored in conformity with the 

protocol.

    (c) Specimens shall be identified by test system, study, nature, and 

date of collection. This information shall be located on the specimen 

container or shall accompany the specimen in a manner that precludes 

error in the recording and storage of data.

    (d) In animal studies where his to pa thol ogy is required, records 

of gross findings for a specimen from post mor tem observations shall be 

available to a pathologist when examining that specimen his to path o 

log ically.

    (e) All data generated during the conduct of a study, except those 

that are generated by automated data collection systems, shall be 

recorded directly, promptly, and legibly in ink. All data entries shall 

be dated on the day of entry and signed or initialed by the person 

entering the data. Any change in entries shall be made so as not to 

obscure the original entry, shall indicate the reason for such change, 

and shall be dated and signed or identified at the time of the change. 

In automated data collection systems, the individual responsible for 

direct data input shall be identified at the time of data input. Any 

change in automated data entries shall be made so as not to obscure the 

original entry, shall indicate the reason for change, shall be dated, 

and the responsible individual shall be identified.