CITI Graded A+
1. What does "Reference item" mean in OECD GLP definitions, and how does it differ from "reference
substance" in EPA GLPs? - Answer: The terms are distinct, and "reference item" should be interpreted according to the specific
study plan context.
2. How can a small company ens...
CITI Graded A+
1. What does "Reference item" mean in OECD GLP definitions, and how does it differ from "reference
substance" in EPA GLPs?
- Answer: The terms are distinct, and "reference item" should be interpreted according to the specific
study plan context.
2. How can a small company ensure compliance with GLP if technical personnel also perform QA
functions?
- Answer: Technical staff would receive training in QA responsibilities but would only oversee projects
where they had no direct involvement.
3. What is meant by "Experimental Starting Date" in OECD regulations?
- Answer: It refers to the initial date when study-specific data collection begins.
,4. Are "Study Plan" and "Study Protocol" interchangeable terms in OECD and U.S. regulatory (EPA, FDA)
contexts?
- Answer: Yes, they are completely interchangeable.
5. When does the term "Sponsor" refer to something other than a person?
- Answer: It applies to a testing facility that both initiates and conducts the study.
6. What does the FDA term "nonclinical laboratory study" exclude?
- Answer: It excludes basic exploratory studies aimed at assessing the potential utility of a test article.
An in vivo nonclinical laboratory study is distinguished by: ✔️Its focus upon a living test system versus a
study using cell cultures grown in a petri dish
,The term, "test system" in the FDA, EPA, and OECD GLPs refers to: ✔️The living or chemical system that
will be treated with or administered the test article (FDA), test item (OECD), or test substance (EPA)
In a "primary eye irritation" study in rabbits, the technician will examine and compare the appearance of
the treated eye with the untreated eye. Which term applies to the untreated eye? ✔️Control
"Study Plan" and "Study Protocol" are: ✔️Completely interchangeable OECD and U.S. regulatory (EPA,
FDA) terms
Regardless of which employee performs a remedial operation (one that corrects conditions caused by an
unforeseen circumstance), which staff member is responsible for noting, correcting, and ensuring the
actions were documented? ✔️The study director
, The quality assurance (QA) officer notes that the records from mouse necropsies have not been copied
for sending to the pathologist for a particular study. The study director's response is that no abnormal
effects were found in any of the four groups of mice, so he/she felt it was not necessary to send the 40
pages of data to the pathologist. As management reviewing the QA report, are you satisfied with the
study director's response? ✔️No, because the study conduct portion of the GLPs requires that
pathologists be provided with the records of gross findings from the necropsy.
Subpart D of both the FDA and EPA GLPs provides the regulations for data-generating equipment.
Testing facility management will need to develop a quality system to ensure the validity of equipment
raw data. Which of the following pieces of equipment does not generate any raw data? ✔️A locked
freezer that is used to store samples of blood from study animals conducted under GLPs
In the process of federal rulemaking (regulation), the preambles serve to: ✔️Announce the effective
date for compliance after presenting reasons for the new law and response to public comments, when
applicable
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