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SAEs

Last updated about 7 years ago

8 questions

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Question 1

1.

Which kind of tests are expected to be recorded on the SAE form?

Any test performed

Relevant tests performed

Lab reports only

Lab reports and X Rays

Question 2

2.

Which kind of tests are expected to be recorded on the SAE form?

Any test performed

Relevant tests performed

Lab reports only

Lab reports and X Rays

Question 3

3.

Which kind of tests are expected to be recorded on the SAE form?

Any test performed

Relevant tests performed

Lab reports only

Lab reports and X Rays

Question 4

4.

Supporting documents must be always submitted

True

False

Question 5

5.

For a SAE follow up...

To cross out the initial form.

To cross out the previous follow up.

Always use a new blank SAE Report Form. 

None of them.

Question 6

6.

Question 7

7.

Who signs SAE forms?

The study coordinator

An investigator or designee

The patient

Question 8

8.

How long is the period of reporting for SAEs?

1 day

48 hours

24 hours

A SAE Follow up must contain...

AER# if known

Protocol # and Subject # on every page

DOB

Study drug if not pre-populated

New SAE reported or No new adverse event

 Narrative to indicate if it is a follow up, new, updated, corrected, additional information.   

 Reporter data 

 Authorized signature and date 

No matters, the form has to be submitted once the site staff has collected all the information. 