SERIOUS ADVERSE EVENT REPORT

Adverse Events must be summarized on this control sheet. MEDWATCH or CIOMS reports should also be attached.

Bruyère Continuing Care REB Protocol Number:
Protocol Title:
Principal Investigator at Bruyère Continuing Care:
Therapeutic Product name:
Date of this Report:
(Sent to REB)
Number of Adverse Events Included in this Report:

ID

/

Type

/

Location

/

Is it drug related?

/

Event Name

/ REB Section Comments /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /
SAE #:
Sponsor Date:
Onset Date: /

Initial

F/U # / EBH External / Yes
No
Possibly /

Recommend changes to: protocol Informed consent No changes

Comments:

Signature of Principal Investigator Date

PLEASE FORWARD TO: Bruyère Continuing Care, Research Ethics Board, 43 Bruyère Street, Ottawa, ON, K1N 5C8

THIS SECTION IS TO BE COMPLETED BY THE REB ONLY

Recommend changes to: protocol Informed consent

Comments:

Signature of Bruyère Continuing Care, REB Chair Date

Version Dec. 2010