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ORTHO SOCRA PREP

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

By: Rebecca Smith
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Decks in this class (10)

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

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ORTHO SOCRA PREP

  • Class purpose General learning

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