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SOCRA 2025

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

By: Kimberly Burken
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Decks in this class (14)

45 CFR Part 46
Activities excluded from research...,
Can inds ides be utilized for mul...,
What does 45 cfr 46 subpart b c d...
6  cards
Devices
2 step process for hde 1,
4 types of devices 2,
Abbreviated ide requirements for ...
36  cards
Drugs
Ae linked to ip 1,
Dispensing ip 2,
Fda bioresarch monitoring program...
9  cards
FDA Specific
Amendment requirements for ich vs...,
Emergency use drug vs device 2,
Fda inspection 3 outcomes 3
12  cards
Human Subjects
A purpose of monitoring clinical ...,
Any subject enrolled to a non tre...,
Clinical investigation vs clinica...
14  cards
Informed Consent
2 methods of informed consent 1,
3 key features of informed consent 2,
45 cfr 46 g waiver for screening ...
25  cards
IRBs
Continuing reviews must be submit...,
Disability the department of educ...,
Documents that must be submitted ...
19  cards
Records
Fda record retention 1,
Ich essential documents 2,
Ich record retention 3
10  cards
Regulations
1st us regulation 1,
2 important goals of icfh e6 stan...,
3 principles of the belmont repor...
31  cards
Reporting
A sponsor investigator shall reta...,
A sponsor needs to report ind saf...,
A sponsor shall notify all irbs i...
34  cards
Reporting Timelines
510k premarket notification 1,
A significant risk device investi...,
Active protocol 3
59  cards
Sponsors and Investigators
1571 ind fda submissions 1,
A sponsor can transfer any or all...,
Cover sheet for an ind application 3
25  cards
Unanticipated Problems
Adverse event ae 1,
Adverse event as unanticipated pr...,
Ae severity serious 3
19  cards
Vulnerable Populations
45 cfr 46 subpart d 21 cfr 50 sub...,
Different levels of assent ex afch 2,
Guidelines on the inclusion of ch...
11  cards

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SOCRA 2025

  • Class purpose General learning

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