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Madison R
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Decks in this class (23)
21 CFR Part 11
What does 21 cfr part 11 cover,
What is a closed system,
What is an open system
13
cards
21 CFR Part 50
What does 21 cfr part 50 cover,
What three applications are inclu...,
Clinical investigation means
12
cards
21 CFR Part 56
What does 21 cfr part 56 cover,
Each irb should have at least how...,
Each irb shall include
10
cards
21 CFR Part 312
What does 21 cfr part 312 cover,
Clinical investigation of a drug ...,
What products are exempt from req...
18
cards
21 CFR Part 812
What is cfr 21 part 812,
What is a significant risk device,
What is a transitional device
11
cards
45 CFR Part 46
What does 45 cfr part 46 cover,
Dead fetus,
Fetus
18
cards
FDA Forms
Fda form 482,
Fda form 483,
Fda form 1572
7
cards
The Belmont Report
Which act was signed in to law in...,
The national research act,
What is the national commission f...
17
cards
The Nuremberg Code
What is the nuremberg code,
Ethical principle 1 _______ is ab...,
Ethical principle 2 the experimen...
20
cards
Declaration of Helsinki
What is the world medical associa...,
Who is the wma declaration of hel...,
What topics does the doh address
6
cards
ICH Harmonised Guideline for Good Clinical Practice
What is the ich,
Ich harmonised guideline for good...,
What does gcp cover
18
cards
ICH Clinical Safety Data Management
Adverse event or adverse experience,
Adverse drug reaction adr definit...,
Adverse drug reaction adr definit...
8
cards
Investigator roles and responsibilities
What are the required qualificati...,
All trial related medical or dent...,
True or false the investigator an...
36
cards
Sponsor's roles and responsibilities
If sponsor obligations are assume...,
Before permitting an investigator...,
What are the important components...
27
cards
IND Reporting
For an ind how soon should the sp...,
For an ind how soon should the sp...,
For an ind what form is used for ...
21
cards
Informed Consent
What are the essential components...,
What are the additional component...,
A sponsor is arguing informed con...
16
cards
IRBs
According to 45 cfr part 46 is th...,
According to 45 cfr part 46 is th...,
According to 45 cfr part 46 is th...
31
cards
Definitions
What is quality assurance,
What is quality control,
Serious adverse events saes or se...
5
cards
Clinical Trial Protocol and IB
According to ich gcp what general...,
According to ich gcp what type of...,
According to ich gcp what types o...
10
cards
Miscellaneous questions
What 3 ethical principles are des...,
To what 3 areas do the rules esta...,
What are the 10 principles establ...
14
cards
IDE
True or false fda form 1572 is re...,
What types of devices are conside...,
What does capa stand for
11
cards
Information Sheets
Does an irb need to register with...,
What is an assurance is it requir...,
Can irb members be paid for their...
20
cards
Conflicts of Interest
Primary strategies for eliminatin...
1
cards
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SOCRA CCRP 2020
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Looking for something else?
SOCRA CCRP Flashcards
- 10 decks
- 186 flashcards
- 1564 learners
Decks:
Investigator Roles And Responsibilities, Sponsor S Roles And Responsibilities, Ind Reporting, And more!
SOCRA 2020
- 12 decks
- 247 flashcards
- 1088 learners
Decks:
21 Cfr Part 11, 21 Cfr Part 50, 21 Cfr Part 56, And more!
CCRP
- 24 decks
- 323 flashcards
- 242 learners
Decks:
Conflicts Of Interest, 21 Crf Part 11, 21 Cfr Part 50, And more!
