SOCRA CCRP Exam > FDA Forms > Flashcards

FDA Forms Flashcards

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1
Q

What is Form 482?

A

Notice of Inspection

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2
Q

What is Form 483?

A

Inspectional Observations

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3
Q

What is Form 1572?

A

Statement of Investigator

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4
Q

What is Form 3454?

A

Certification: Financial Interests and Arrangements of Clinical Investigators

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5
Q

What is Form 3455?

A

Disclosure: Financial Interests and Arrangements of Clinical Investigators

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6
Q

What is Form 3500?

A

MedWatch: For VOLUNTARY reporting of AEs, product problems, and product use errors

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7
Q

What is Form 3500A?

A

MedWatch: For use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting

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