Record Keeping in Lab Animal Research

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10 Terms

1
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What is the purpose of GLPs?

Govern technical conduct of research from start to finish

2
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GLPs regulate which of the following types of research

safety testing of various products for human and animal use including drugs

3
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Which individual represents the single point of study control at the research facility

study directory

4
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what do you call a chronological list of action steps written for completion of a tast?

SOPs

5
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Which of the following is NOT an example of raw data

biological specimens

copied temperature from printouts into a notebook

ECG tracing printouts from an animal

photocopies of raw data signed and dated

copied temperatures form printouts into a notebook

6
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Which of the following DOES NOT result in a facility getting disqualifies?

When noncompliance negatively impacts validity of research dats

when efforts to comply following violations are insufficient to bring the facility into compliance

quality assurance inspections had to be performed during a study

failure to comply with one or more GLPs

quality assurance inspections had to be performed during a study

7
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quality assurance reports directly to the study director and must alo be engaged in research

false

8
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standard SOPs are written out step-by-step within each study protocol

false

9
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only the most current SOPs must be kept for record inspection; previous drafts are discarded

false

10
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personnel must be trained to perform each SOP; SOPs are not training manuals!

True