Local Serious Or Unexpected Adverse Event Notification Form

Local Serious Or Unexpected Adverse Event Notification Form

LOCAL SERIOUS OR UNEXPECTED ADVERSE EVENT NOTIFICATION FORM

VA Long Beach Healthcare System

Instructions: Use this form to submit reports of serious and unexpected adverse events occurring in subjects at the investigator’s own site. A separate report must be submitted for each incident. Please complete all sections of this form.
Submit this application with the following:
Copies of relevant hospital records, notes, lab tests, etc.
Copies of all reports made to the sponsor or FDA
Please black out any patient identifiable information
PRINCIPAL INVESTIGATOR (Last, First, M.I., Degree) / PROJECT NUMBER / DATE
PROJECT TITLE
1. EVENT (diagnosis preferred): Initial Report Follow-up Report
2. Subject's birth date Initials Sex F M
3. Date of onset: Date PI became aware
4. Study article
5. Route of administration: Administered from to

VALBHCS Version Date: 3/1/2013

Replaces Version Date: 7/13/2006

6. Classification of Adverse Event (Check all that apply):
Serious Adverse Event (SAE) is an adverse event or adverse drug reaction occurring in a subject that resulted in the following:
Death: Date Cause of death
Immediately life-threatening occurrence
Admission or prolongation of hospitalization: Date of admission
Severe or permanent disability
Congenital abnormality
Required medical or surgical intervention to prevent one of the above
Other
Unexpected Adverse Event (UAE) is any adverse event and/or reaction, the specificity or severity of which is not consistent with the informed consent, current investigator brochure or product labeling. Further, it is not consistent with the risk information described in the general investigational plan or proposal. Please describe below:

VALBHCS Version Date: 3/1/2013

Replaces Version Date: 7/13/2006

7. Describe the serious or unexpected adverse event, including pertinent past medical history, concomitant medications, treatment and patient outcome. Attach copies of hospital admission data and other data as appropriate.(Please black out any patient identifiable information.)
8. a) In the investigators opinion, was the event related to the study article?
Definitely (100%) Probably (>50%) Possibly (<50%) Not related (0%)
b) If related, is the risk currently stated in the informed consent? Yes No
c) Explain why the investigator holds this opinion
9. Is a change to the informed consent form or protocol required? Yes No If yes, please submit a Request for Modification Form.
a) Explain why (both Yes and No answers):
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

VALBHCS Version Date: 3/1/2013

Replaces Version Date: 7/13/2006

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