SAEs

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

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

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

1

Supporting documents must be always submitted

Tačno

Netačno

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.

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

1

Who signs SAE forms?

The study coordinator

An investigator or designee

The patient

1

SAEs

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

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

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

Supporting documents must be always submitted

For a SAE follow up...

A SAE Follow up must contain...

Who signs SAE forms?

How long is the period of reporting for SAEs?

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

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

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

Supporting documents must be always submitted

For a SAE follow up...

A SAE Follow up must contain...

Who signs SAE forms?

How long is the period of reporting for SAEs?