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Erin Larsen
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Decks in this class (15)
CCRP virtual course
Assuring the safety effectiveness...,
Who develops sops who approves so...,
Cfr title 21 part 11
161
cards
21 code of federal regulations
21 pt 11 is what cfr,
Signed electronic records shall c...,
Electronic signatures that are no...
37
cards
Investigational New Drug Application
An ind may be submitted for one o...,
What are the fda s primary object...,
What are the fda s primary object...
19
cards
45 part 46 - Protection of Human Subjects
45 part 46,
45 part 46 part a,
To what does the 45 part 46 part ...
43
cards
FDA forms
What is fda form 482,
What is fda form 483,
What is fda form 1572
8
cards
The Belmont Report
What act was signed into law that...,
When was the belmont report founded,
What is part a of the belmont report
9
cards
Nuremberg Code
What year wsa the nuremberg code ...,
This code came about as a result ...,
What are the 10 ethical principle...
3
cards
Declaration of Helsinki
When was the world medical associ...,
What are the principles of declar...
2
cards
ICH Harmonised Guideline for Good Clinical Practice E6 (R2)
When was the ich guideline finali...,
The guidance was developed with c...,
What is e2ae3e7e8e9e11
30
cards
Essential documents - before the clinical phase of the trial commences
Investigator brochure,
Signed protocol and amendments an...,
Information given to trial subjec...
20
cards
Essential documents - during the clinical conduct of trial
Investigator s brochure updates,
Any revision to protocol amendmen...,
Dated documented approval favorab...
25
cards
Essential documents after completion or termination of the trial
Investigational product s account...,
Documentation ofinvestigational p...,
Completed subjectidentification c...
8
cards
CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartite Guideline
There are two issues within the b...,
When doing expedited reporting wh...,
There are situations in addition ...
8
cards
Timelines
How many days does a sponsor have...,
How long must an irb retain recor...,
How many days does the irb have t...
35
cards
Early/Expanded Access
What is the criteria requirements...,
What is the criteria requirements...,
What is the criteria requirements...
4
cards
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CCRP test
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