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Erin Clements
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Decks in this class (11)
Nuremburg, Helsinki, Belmont
Year of nuremburg code,
Year of declaration of helsinki,
Year of belmont report
12
cards
45 CFR Part 46
Which part of 45 crf part 46 is c...,
What is subpart a of 45 cfr part ...,
What is subpart b of 45 cfr part ...
40
cards
21 CFR Part 312
When does an investigational prod...,
What is the topic of 21 cfr part 312,
Can sponsors charge for investiga...
32
cards
Vocabulary Words & Definitions
Suspected adverse reaction,
Unexpected ae or unexpected suspe...,
Life threatening ae or life threa...
105
cards
21 CFR Part 56
What is 21 cfr part 56 about,
Irb authority,
How many members must an irb have
35
cards
42 CFR Part 11
What is 42 cfr 11,
Which section deals with clinical...,
Per 42 cfr 11 where must clinical...
5
cards
21 CFR Part 50
What types of research are subjec...,
What is 21 cfr part 50,
Which other cfr covers the concep...
14
cards
SAEs, AEs, Unexpected Problems
What is an unanticipated problem,
What kind of event is unexpected ...,
When does an adverse event need t...
24
cards
ICH E6
Ich e6 investigator obligations,
What constitutes adequate site re...,
Per ich e6 who should be informed...
56
cards
Miscellaneous
By signing the 1572 the pi agrees to,
What do sponsors do with complete...,
What is 21 cfr 54 about
69
cards
21 CFR 812
What is 21 cfr part 812 about,
Required parts of an ide submission,
Device risk categories
29
cards
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SOCRA 2024
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SOCRA 2024
- 9 decks
- 244 flashcards
- 20 learners
Decks:
Fda Forms, Ethical Guidelines And Regulations, Declaration Of Helsinki, And more!
SOCRA 2023
- 16 decks
- 488 flashcards
- 770 learners
Decks:
21 Cfr Part 11, 21 Cfr Part 50, 21 Cfr Part 56, And more!
SOCRA 2024 Flashcards
- 8 decks
- 283 flashcards
- 2 learners
Decks:
1 Crf Part 312 Investigational New Drug, 21cfr50 5020 Scope, 21 Cfr 812 Investigational Device Exempt, And more!
SOCRA 2020
- 12 decks
- 247 flashcards
- 1090 learners
Decks:
21 Cfr Part 11, 21 Cfr Part 50, 21 Cfr Part 56, And more!
