Code Of Federal Regulations Flashcards

1
Q

45 CFR Part 46

A

HHS Regulation for the protection of human subjects in research. Includes 5 subparts.

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2
Q

45 CFR 46 Subpart B

A

Additional protections for pregnant women, human fetuses and neonates involved in research.

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3
Q

45 CFR 46 Subpart C

A

Additional protections pertaining to biomedical and behavioral research involving prisoners as subjects.

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4
Q

45 CFR 46 Subpart D

A

Additional protections for children involved as subjects in research.

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5
Q

21 CFR Part 11

A

Regulations for electronic records, electronic signatures, and handwritten signatures executed to electronic records.

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6
Q

21 CFR Part 50

A

Protection of human subjects in all clinical investigations regulated by the FDA.

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7
Q

21 CFR Part 56

A

General standards for IRBs that review clinical investigations regulated by the FDA.

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8
Q

21 CFR Part 312

A

Procedures and requirements governing the use of investigational new drugs (INDs).

INVESTIGATIONAL NEW DRUGS

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9
Q

21 CFR Part 812

A

Provides procedures for the conduct of clinical investigations of devices.

INVESTIGATIONAL DEVICES

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10
Q

What two forms provide regulations that govern IRBs?

A

45 CFR 46 & 21 CFR 56

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11
Q

What form regulates the informed consent process of human subjects?

A

21 CFR 50

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