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2.2 Good Clinical Practice

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

By: John Chuter
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Decks in this class (9)

Belmont Report
Basic ethical principles,
Informed consent,
Belmont report goals
10  cards
FDA Reg. for Investigational Devices
Humanitarian device exemption,
Humanitarian use device,
Investigational device exemption
19  cards
Investigator Obligations in FDA-Regulated Clinical Investigations of Devices
Contract research organization cro,
Investigator,
Sponsor
8  cards
Conducting Investigator-Initiated Clinical Investigations of Devices
Off label use approval,
Investigator,
Device
7  cards
Managing Investigational Devices According to GCP Requirements
Blinded trial,
Randomized trial,
Limits on device propagation
5  cards
Informed Consent in Clinical Investigations of Devices
Assent,
Informed consent,
Legally authorized representative...
4  cards
Monitoring Clinical Investigations of Devices
Monitoring
1  cards
Audits and Inspections of Clinical Investigations of Devices
Audit,
Monitoring,
Inspection
3  cards
Reporting Requirements for Clinical Investigations of Devices
Institutional review board irb,
Regulation,
Investigators must submit the fol...
4  cards

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2.2 Good Clinical Practice

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