Important Dates Flashcards

1
Q

OHRP

A

2000

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2
Q

FDA Regulations

A

1980

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3
Q

HHS & FDA revised regulations

A

1981

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4
Q

Common Rule

A

1991

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5
Q

Congress developed HIPAA and gave it to:

A

1996
Department of health and human services

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6
Q

The National Research Act

A

1974

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7
Q

When do you not need IRB approval?

A

BEFORE July 27,1981

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8
Q

ICH developed GCP

A

1996

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9
Q

ICH finalized GCP (amendment)

A

2016

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10
Q

The Belmont Report

A

1978

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11
Q

The Nuremberg code

A

1947

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12
Q

Declaration of Helsinki

A

1964

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13
Q

Transitional Device

A

device distributed BEFORE May 28, 1976

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14
Q

Device

A

into commercial distribution AFTER 1976

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15
Q

ICH established

A

April 1990

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