SAEs
starstarstarstarstarstarstarstarstarstar
by Cristina Blasco Lozano
| 8 Questions
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
2
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
3
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
4
1
Supporting documents must be always submitted
True
False
5
1
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.
6
1
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
7
1
Who signs SAE forms?
The study coordinator
An investigator or designee
The patient
8
1
How long is the period of reporting for SAEs?
1 day
48 hours
24 hours
No matters, the form has to be submitted once the site staff has collected all the information.

Add to my formatives list

Formative uses cookies to allow us to better understand how the site is used. By continuing to use this site, you consent to the Terms of Service and Privacy Policy.