DEPARTMENT OF RESEARCH

Institutional Review Board

Adverse Event Report

IRB #:

     

Principal Investigator:

     

Phone Number:

     

E-mail:

     

Protocol Title:

     

Number of Subjects Currently Enrolled at LBH, Inc.:

     

Total Number of Adverse Events Reported at LBH to Date:

     

Number of Adverse Events related to protocol:

     

Number of Adverse Events Reported at LBH Similar to this One:

     

1. Location where adverse event occurred:

Subject coded identifier or study ID #:

     

2. Date of event:

     

3. Brief description of the adverse/unexpected event, actions taken and outcome:

     

4. Sponsor:

     

Has the event been reported to the sponsor?

5. Was an investigational drug or device involved?

If yes, IND/IDE #

     

6. The event was:

7. This determination was made by:

8. What was the severity of the event?

9. For unexpected adverse events that were life threatening or fatal, and were possibly or likely related to the protocol, provide:

Number of subjects enrolled study-wide:

l

Number of events:       as of       (date)

Additional information/explanation:

     

10. Does this unexpected serious adverse event require a revised protocol?

If yes, please describe change(s):

     

11. Does this unexpected serious adverse event require a revised Consent Form?

If yes, please submit two copies of the revised Consent Form: one clean copy and one copy with all revisions clearly marked.

12. Does this unexpected serious adverse event increase the likely risk or decrease the likely benefit of the study?

If yes, please explain:

     

Please note: If you selected “Unrelated to the protocol” in response to question 6 and “No” in response to questions 10, 11, & 12, then you do not have to report this adverse event at this time. Include this adverse event form in your annual report along with your continuing renewal. Note that a fatal or life-threatening event that occurs while a subject is being treated on protocol or occurs within 30 days of completing research related interventions is an exception to the above policy and must be reported to the Division Chief within 24 hrs and to the IRB within 3 days. For more information, see the LBH Guidelines for Adverse Event Reporting.

____________________________________ ________________________

Signature of Principal Investigator Date

Please return this form with all relevant attachments to:

Patricia Lohinski, CIM

LifeBridge Health Institutional Review Board

Department of Research

Sinai Hospital of Baltimore

Schapiro Building, Suite 203

2401 W. Belvedere Avenue

Baltimore, Maryland 21215-5271

Phone: 410-601-9021

Fax: 410-601-8282

E-Mail: [email protected]

www.LifeBridgeHealth.org

LBH IRB Form #3: Adverse Event Report Page 1 of 5

Version 1.3 – 06-29-10