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Decks in this class (10)
Glossary ICH E6(R2)
Adverse drug reaction adr 1,
Adverse drug reaction adr 2,
Adverse event ae 3
71
cards
ICH Harmonised Tripartite Guideline E2A
Two issues at core of ich harmoni...,
Severe versus serious 2,
A serious event is any untoward m...
17
cards
ICH E6(R2)
Good clinical practice gcp 1,
What document is the origin of tr...,
Objective of ich gcp 3
22
cards
Guiding Principles
The 1974 national research act cr...,
The national commission for the p...,
Belmont report 1978 3
9
cards
Informed Consent
Definition of informed consent 1,
The common rule 45 cfr 46 2,
Essential elements of informed co...
9
cards
Safety Management
Ar 1,
Adverse drug reaction before mark...,
Adverse drug reaction after marke...
24
cards
Investigational Product
Recordkeeping 1,
Investigational new drug 2,
Form fda 1571 3
4
cards
Audits, inspections, and monitoring
Audit 1,
Inspection 2,
Monitoring 3
4
cards
Medical Devices
Class i devices 1,
Class ii devices 2,
Class iii devices 3
13
cards
General Questions
Minimum number of irb members 1,
In a non emergency situation unde...,
The responsibility for ensuring t...
52
cards
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ORTHO SOCRA PREP
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