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CPM Training GCP FDA QUIZ

this is an online self-evaluation questionnaire

mandatory answer

Question 1

Thank you to enter here your pseudonym

mandatory answer

Question 2

This tragedy in 1938 lead to the U.S. Food, Drug, and Cosmetic Act, which subjected new drugs to pre-market safety evaluation for the first time. 

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Question 3

 What is the objective of Pre-Clinical trial?

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Question 4

This type of application is filed after animal tests, to grant permission for human testing

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Question 5

This study phase establishes both safety and efficacy in typically hundreds of patients

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Question 6

This FDA document type tells you what you are required to do by law

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Question 7

This FDA document type tells you the best way to do it

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Question 8

List 3 documents that are source data/documents

mandatory answer

Question 9

When the EMA has been created

mandatory answer

Question 10

Who is responsible to maintain the case history of each patient




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