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ACRP Certification

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

By: Kassandra Nealon
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Decks in this class (11)

ICH E6 – Guideline for Good Clinical Practice/GCP
What is the objective of ich gcp 1,
What should be weighed or conside...,
What does adr stand for 3
100  cards
ICH E2 Clinical Safety Data Management
Where can risk reduction activiti...,
Describe serious expected adrs ex...,
What is the standards for serious...
21  cards
ICH E8- General Considerations for Studies
What are examples of a human phar...,
Dose response exploration studies...,
The following studies describe wh...
81  cards
ICH E9- Statistical Principals for Clinical Trials
What are the 3 aims of a developm...,
What variable should be capable o...,
T f there should generally be mor...
35  cards
ICH E11- Clinical Investigation of Medicinal Products in the Pediatric Population
What is the age classification of...,
What is the age classification of...,
What is the age classification of...
7  cards
Declaration of Helsinki
Who developed the declaration of ...,
What is the purpose of medical re...,
According to the declaration of h...
17  cards
Practice Questions
What would be the first priority ...,
A cro recently switched from pape...,
Part of a sponsor s responsibilit...
178  cards
Belmont Report
Which 3 fundamental ethics princi...,
Who wrote the belmont report 2,
What are the principles behind re...
7  cards
Roles and Responsibilities
Whose responsibility is it to com...,
Whose responsibility is it to ove...,
Whose responsibility is it to man...
41  cards
ICHs
Ich 2 1,
Ich e5 2,
Ich e8 3
10  cards
Reporting Timeframes
How long must the irb keep corres...,
How long do essential documents h...,
How long does the fda have to rev...
8  cards

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ACRP Certification

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