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allison iwan
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Decks in this class (15)
21 CFR Part 11
What is a closed system,
What is an open system,
What does act refer to
35
cards
21 CFR Part 50
According to 21 cfr part 50 docum...,
What is a sponsor investigator,
An informed consent should never ...
31
cards
21 CFR Part 56
The minimal interval that an irb ...,
In order for research to be appro...,
An irb shall require documentatio...
30
cards
21 CFR Part 312
Grounds for imposition of a clini...,
The immediate package of an inves...,
Subject means a human who partici...
94
cards
21 CFR Part 812
In 21 cfr part 812 to what does a...,
In 21 cfr part 812 to what does i...,
In 21 cfr part 812 to what does i...
80
cards
45 CFR Part 46
Research,
Human subject,
Intervention
47
cards
FDA Forms
For use by user facilities distri...,
Inspectional observations a fda f...,
Disclosure financial interests an...
43
cards
The Belmont Report
Beneficence defined by the belmon...,
Justice defined by the belmont re...,
_________ has a reasonable expect...
24
cards
The Nuremburg Code
The nuremberg code was developed ...,
The nuremberg code is a list of 1...,
The history of ethical regulation...
9
cards
Declaration of Helsinki
According to the declaration of h...,
The declaration of helsinki state...,
The declaration of helsinki was c...
9
cards
ICH Guideline for GCP
The guideline for good clinical p...,
The international ethical and sci...,
The consent form should include m...
52
cards
ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
The term side effect should be re...,
Seriousness not severity serves a...,
Adverse drug reactions are catego...
18
cards
Other Reading
What do usual measures of adverse...,
What is the common rule,
What is beneficense
213
cards
SOCRA self study
Risk management principles are ef...,
______________ consists of the id...,
The purpose of ________ is to red...
53
cards
SOCRA Continuing Competence Learning Module v16
Cfr,
Dsmb,
Gcp
20
cards
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SOCRA_2015
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