Irb Office Use
VA Long Beach Healthcare System
Instructions: Use this form to submit reports of serious adverse events (SAE) occurring in subjects not enrolled at your site. If modifications to the protocol or consent are required, attach a revised protocol and/or informed consent form and a completed Request for Modification form.
Do NOT submit this form UNLESS one or more of the following is true:
1. The event was unexpected.
2. The event was serious*(Please see list below for details)
3. The event was related to the study or there was a reasonable probability that the adverse event may have been caused by the study.
4. The event was harmful (which suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized.)
5. The event is not described in the Informed Consent Form.
PRINCIPAL INVESTIGATOR (Last, First, M.I., Degree) / PROJECT NUMBER
/ DATE
PROJECT TITLE
IND Safety Report # / Date of Onset / Description of Event / Definitely or
Probably / Change in ICF or Protocol Req'd? (Yes/No)
1. Did the AEs occur in the disease or condition being studied at VALBHS? Yes No
PRINCIPAL INVESTIGATOR SIGNATURE DATE
IRB OFFICE USE:
To be completed by SAE Ad Hoc Chairman:
1. Additional procedures are required to minimize risk? Yes No N/A
2. The protocol requires revision? Yes No N/A
3. The risk benefit relationship of the research is still acceptable? Yes No N/A
4. The consent form requires revision? Yes No N/A
5. Do the subjects need to be informed of any new information? Yes No N/A
6. Should the study be suspended or terminated? Yes No N/A
Action:
Approved by SAE Ad Hoc Chairman
Requires full committee review : This Non-Local SAE has been reviewed by the IRB at the meeting on ______.
Comments:
______
Macy Ho, Pharm.D. Date
AE Ad Hoc Chairperson, IRB
*FAQ:
Definition of Serious Adverse Event (any one of the following):
a. Death
b. A life-threatening situation
c. Inpatient hospitalization
d. Prolongation of existing hospitalization
e. Persistent or Significant disability
f. A birth defect
g. Other events which require medical intervention to prevent one of the outcomes listed above.
VALBHCS Version Date: 03/01/2013
Replaces Version Date: 07/15/2008