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ccrp exam

This class was created by Brainscape user Victoria Williams. Visit their profile to learn more about the creator.

By: Victoria Williams
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Decks in this class (14)

Title 21, Part 56 - IRB
Emergency use,
Investigator,
Sponsor
16  cards
Title 21, Part 312 - Investigational New Drug Application (IND)
Contract research organization de...,
Act definition only,
Independent ethics committee iec ...
38  cards
Title 21, Part 50 - Protection of Human Subjects
Exceptions to informed consent ge...,
If informed consent is not requir...,
Exceptions from informed consent ...
12  cards
IND reporting
Adverse event,
Life threatening adverse event or...,
Serious adverse event or serious ...
5  cards
Title 21, Part 812 - Investigational Device Exemption
Waivers,
Who submits an ide application to...,
Contents of an ide in order
21  cards
FDA Forms
Fda form 482,
Fda form 483,
Fda form 1572
7  cards
ICH E6 GCP - IRB
Irb responsibilites ich,
Irb composition ich e6 gcp,
Irb procedures ich e6 gcp
4  cards
Investigator Responsibilities - ICH
Responsibilties,
Randomization and blinding what r...,
Records
8  cards
Sponsor Responsibilities - ICH
Responsibilities of sponsor,
Quality management,
Trial design
12  cards
Monitor Responsibilities - ICH
Purposes of trial monitoring,
Who appoints monitors,
Monitor s responsibilities
8  cards
Clinical Trial Protocol and Amendments - ICH
General information,
Background information,
Trial objectives and purpose
16  cards
Investigators Brochure - ICH
Purpose,
Who is responsible for ib,
Contents
3  cards
ICH Reporting Timelines
Fatal or life tberatening unexpec...,
Serious unexpected reactions adrs...
2  cards
Title 21, Part 11 - Electronic Records
When must clinical trial registra...,
Closed system,
Open system
8  cards

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ccrp exam

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