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My SOCRA Exam Flash Cards > Cchmc Review > Flashcards

Cchmc Review Flashcards

1
Q

Nuremberg code

Year?

A

1947

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2
Q

Nuremberg code

Who created?

A

After WWII, from trials of German scientist. 1st written code for research

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3
Q 
Nuremberg Code
Major themes (3)
A
  1. Voluntary consent
  2. Risk vs benefit
  3. Research must be conducted by experienced staff
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4
Q

Declaration of Helsinki

Year?

A

1964

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5
Q

Declaration of Helsinki

Who created?

A

World Medical Association (WMA)

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6
Q 
Declaration of Helsinki
Major themes (5)
A
  1. Physicians duty to protect subjects/collect accurate data/disclose conflict
  2. Medical progress is based on research but individuals take precedence over the interests of science
  3. Research should be summarized in a protocol/IC/assent
  4. New methods should be tested against the best current methods
  5. Physicians should be aware of ethical, legal, and regulatory requirements of research
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7
Q

Belmont Report

Year?

A

1979

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8
Q

Belmont Report

Purpose

A

Summarize basic ethical principles

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9
Q 
Belmont Report
Major themes (3)
A
  1. Respect for persons
  2. Beneficence
  3. Justice
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10
Q

Belmont Report

Respect for persons, define:

A
  • individuals treated as autonomous

- protect those with diminished autonomy

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11
Q

Belmont Report

Beneficence, define:

A
  • minimize harm

- maximize benefits

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12
Q

Belmont Report

Justice, define:

A

Fairness in distribution

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13
Q

Nuremberg code

Purpose

A

After WWII, 1st written code for research

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14
Q

Declaration of Helsinki

Purpose

A

International, first significant effort is medical community to regulate itself for research

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15
Q

ICH, stands for:

A

International Conference on Harmonization

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16
Q

ICH, who is it (what countries)?

A

Governmental agencies of Japan, US, European Union, Australia, Canada, WHO, Nordic countries

17
Q

ICH, what is it

A

Governmental agencies and pharmaceutical industry met to develop and promote global standards in clinical research (GCP)

18
Q

GCP (Good clinical practices)

What is it?

A

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

19
Q

GMP, means?

A

Good manufacturing practice. Standards for the manufacturing, storing and handling of investigational products. A principle in GCP.

My SOCRA Exam Flash Cards (3 decks)

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