Basic GLP Knowledge

1.

FDA was the first to implement the GLPs.

A.

True
B.

False

Correct Answer
A. True

Explanation
The statement is true because the FDA (Food and Drug Administration) was indeed the first regulatory agency to implement the GLPs (Good Laboratory Practices). The GLPs are a set of regulations that ensure the quality and integrity of non-clinical laboratory studies conducted to support research or marketing permits for products regulated by the FDA. By implementing the GLPs, the FDA has established a standardized framework for conducting and reporting laboratory studies, which has had a significant impact on the safety and efficacy of various products in the market.

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2.

The study director funds the GLP study.

A.

True
B.

False

Correct Answer
B. False

Explanation
The study director does not fund the GLP study. The funding for the study typically comes from external sources such as government agencies, private companies, or research grants. The study director is responsible for overseeing the study and ensuring that it is conducted in compliance with Good Laboratory Practice (GLP) regulations. However, they do not have the authority to provide funding for the study.

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3.

GLPs were implemented because...

A.

Scientists were fabricating results
B.

Companies did not know what studies had been conducted
C.

Equipment was not maintained
D.

All of the above

Correct Answer
D. All of the above

Explanation
GLPs, or Good Laboratory Practices, were implemented to address multiple issues in scientific research and industry. Firstly, scientists fabricating results was a concern that needed to be addressed in order to ensure the reliability and integrity of research findings. Additionally, the lack of knowledge about conducted studies by companies could lead to duplication of efforts or overlooking important findings. Lastly, the maintenance of equipment is crucial to ensure accurate and valid results. Therefore, implementing GLPs aimed to tackle all these issues and promote transparency, accuracy, and reliability in scientific research and industry practices.

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1

0

4.

The sponsor assigns the study director

A.

True
B.

False

Correct Answer
B. False

Explanation
In a study, the sponsor is responsible for providing the necessary resources and funding for the research. However, it is the responsibility of the study director to oversee and manage the entire study process. The study director is responsible for designing the study protocol, ensuring compliance with regulatory requirements, coordinating the research activities, analyzing the data, and reporting the findings. Therefore, the statement that the sponsor assigns the study director is false.

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5.

GLPs tell you what to do but not how to do it

A.

True
B.

False

Correct Answer
A. True

Explanation
This statement suggests that Good Laboratory Practices (GLPs) provide guidelines or instructions on what needs to be done, but they do not provide specific details on how to carry out those tasks. In other words, GLPs outline the requirements and standards that must be followed in a laboratory setting, but they do not provide step-by-step instructions or procedures for conducting experiments or tests.

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6.

Protocol and SOPs tell you how to do it while GLPs tell you what to do

A.

True
B.

False

Correct Answer
A. True

Explanation
This statement is true because protocols and standard operating procedures (SOPs) provide instructions and guidelines on how to perform a specific task or procedure. They outline the step-by-step process and the specific actions to be taken. On the other hand, Good Laboratory Practices (GLPs) focus on the overall quality assurance and regulatory compliance of the laboratory work. GLPs provide a framework for ensuring the reliability, integrity, and validity of the data generated during laboratory studies. Therefore, while protocols and SOPs provide instructions on how to perform a task, GLPs provide guidelines on what needs to be done to maintain quality and compliance.

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7.

Finish this sentence... If it ain't written down.....

A.

...then the FDA says "It's ok. We'll approve your drug for human trials. Congratulations!"
B.

...then the FDA says, "It didn't get done!"
C.

...then the FDA says, "My yacht is for sale. Wanna buy it?"

Correct Answer
B. ...then the FDA says, "It didn't get done!"

Explanation
If something is not written down, it means that it was not completed or documented properly. In the context of the FDA, if a task or requirement is not written down, the FDA would respond by saying "It didn't get done!" This implies that without proper documentation, the task or requirement cannot be considered completed or acknowledged by the FDA.

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8.

E=

A.

Mc hammer
B.

Mc squared
C.

The speed of an electron

Correct Answer
B. Mc squared

Explanation
The correct answer is "mc squared" because it refers to Einstein's famous equation, E=mc², which states that energy (E) is equal to mass (m) times the speed of light (c) squared. This equation is a fundamental principle in physics and relates mass and energy, showing that they are interchangeable.

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9.

I'm a GLP scientist. I'm required to..

A.

Have GLP training
B.

Maintain equipment
C.

Use good documentation practices
D.

All of the above

Correct Answer
D. All of the above

Explanation
The correct answer is "all of the above" because as a GLP scientist, it is necessary to have GLP training to ensure compliance with the principles and regulations of Good Laboratory Practices. Additionally, maintaining equipment is important to ensure accurate and reliable results in experiments. Lastly, using good documentation practices is essential for recording and documenting all aspects of the research process, including protocols, data, and observations. Therefore, all of these tasks are required for a GLP scientist.

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10.

The study director initiates the protocol when...

A.

He/she signs and dates the protocol
B.

He/she gives it to the sponsor
C.

He/she places the protocol in their briefcase

Correct Answer
A. He/she signs and dates the protocol

Explanation
The study director initiates the protocol by signing and dating it. This indicates their approval and acceptance of the protocol. By signing and dating the protocol, the study director acknowledges their responsibility and commitment to follow the protocol as outlined. This step is important in ensuring that the study is conducted according to the approved plan and meets the necessary ethical and regulatory requirements. Giving the protocol to the sponsor or placing it in their briefcase may be subsequent actions after the protocol has been initiated by signing and dating it.

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0

1

Basic Glp Knowledge

FDA was the first to implement the GLPs.

The study director funds the GLP study.

GLPs were implemented because...

The sponsor assigns the study director

GLPs tell you what to do but not how to do it

Protocol and SOPs tell you how to do it while GLPs tell you what to do

Finish this sentence... If it ain't written down.....

E=

I'm a GLP scientist. I'm required to..

The study director initiates the protocol when...