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SAEs

Last updated almost 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

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 

24 hours

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