SAS Exam A00-280 Topic 3 Question 55 Discussion

Actual exam question for SAS's A00-280 exam

Question #: 55
Topic #: 3

[All A00-280 Questions]

What is the main focus of 21 CFR Part 11?

Aelectronic submission requirements

Btrial safety requirements

Cstatistical calculation requirements

Dtrial protocol requirements

Show Suggested Answer

Suggested Answer: A

by Nieves at Apr 24, 2024, 08:37 AM

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Aleisha

7 months ago

So, the answer should be A) electronic submission requirements then.

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Sheron

7 months ago

Absolutely, it sets standards for the use of electronic records in clinical trials.

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Valene

7 months ago

No, 21 CFR Part 11 focuses on electronic documentation, not specifically on trial safety.

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Yesenia

7 months ago

But what about trial safety requirements? Could it be related to that?

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Sheron

7 months ago

Yeah, I agree with User1. It's definitely related to electronic records and signatures.

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Aleisha

7 months ago

I think 21 CFR Part 11 is about electronic submission requirements.

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Ulysses

8 months ago

D) trial protocol requirements

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Amie

8 months ago

B) trial safety requirements

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Blair

8 months ago

A) electronic submission requirements

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Madelyn

8 months ago

What is the main focus of 21 CFR Part 11?

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