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Weekly GCP Challenge

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.


Challenge: FDA Guidance on the 1572 form

Question Number 1:
What is the purpose of the 1572 form?
A
 To provide information to FDA about investigators
B
 To provide information to the sponsor about investigators qualifications
C
 It is an agreement by the investigator to conduct the study in accordance with relevant FDA regulations
D
 Both B and C

Question Number 2:
If a study is not conducted under an IND (e.g. foreign studies or devices studies) is a 1572 required?
A
 No
B
 Yes
C
 Yes if you wish to submit data from the study as part of an application to FDA
D
 Yes if there are other studies with that investigational product ongoing in the US

Question Number 3:
Must investigators outside the US sign a 1572?
A
 No
B
 Yes
C
 Yes if the study is being conducted under an IND outside the US
D
 Yes if there are study sites in the US for that clinical trial

Question Number 4:
According to FDA guidance on the 1572 form how often should the investigator's CV be updated during an IND Study?
A
 Annually
B
 Every 2 years
C
 Every 3 years
D
 It does not need to be updated

Question Number 5:
Do subinvestigators listed on the 1572 have to provide a statement of qualifications?
A
 No
B
 Yes
C
 Only those which are physicians
D
 Only those which are physicians, nurses or pharmacists

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