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SOCRA 2024 Flashcards

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

By: Melanie Buonanno
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Decks in this class (8)

1 CRF Part 312 – Investigational New Drug Application
Is a new drug in accordance with ...,
What is 21 crf part 312 regarding,
New investigational drug can be d...
37  cards
21CFR50 – §50.20 Scope ​
21cfr50 5020 scope,
The irb is must maintain records ...,
Who signs the short form
15  cards
21 CFR 812– Investigational Device Exemption​
Transitional device,
Cber,
Cder
24  cards
ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting – E2A Guidelines (pages 281-294)​
Ich clinical safety data manageme...,
Adverse event or adverse experien...,
Adverse drug reaction adr definition
14  cards
Electronic records, ​ ICH Principles, ICH Responsibilities of IRB/IEC, and Investigators
The world medical association wma...,
Choose all that applies what are ...,
The fda guidelines from which par...
10  cards
45 Code of Federal Regulations 46​
45 code of federal regulations pa...,
3 major ethical principles and gu...,
The belmont report
17  cards
Ethical Principals found in The Nuremburg Code, Belmont Report & Declaration of Helsinki
10 ethical principals for human e...,
Informed consent participants mus...,
Developed in 1964 by the world me...
39  cards
Reporting timelines
Withdrawl of fda approval,
Significant risk device determina...,
No consent obtained after using d...
12  cards

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SOCRA 2024 Flashcards

  • Class purpose General learning

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