Fillable Irb Adverse Event Report Form (Broward College)

Fill Online, Printable, Fillable, Blank Irb Adverse Event Report Form (Broward College) Form

Use Fill to complete blank online BROWARD COLLEGE pdf forms for free. Once completed you can sign your fillable form or send for signing. All forms are printable and downloadable.

Irb Adverse Event Report Form (Broward College)

On average this form takes 7 minutes to complete

The Irb Adverse Event Report Form (Broward College) form is 3 pages long and contains:

  • 1 signature
  • 14 check-boxes
  • 19 other fields

Country of origin: US
File type: PDF

U.S.A. forms for Broward College

BROWSE BROWARD COLLEGE FORMS

Related forms
Fill has a huge library of thousands of forms all set up to be filled in easily and signed.
Fill in your chosen form
Sign the form using our drawing tool
Send to someone else to fill in and sign.
find another form
 
Page 1 of 1
IRB-ADF – (10/13)
Instructions: Federal regulation requires that any Adverse Events associated with participation in a research study be
reported to the IRB. The U.S. Department of Health & Human Services defines an Adverse Event as follows:
Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign
(for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally
associated with the subject’s participation in the research, whether or not considered related to the
subject’s participation in the research (modified from the definition of adverse events in the 1996
International Conference on Harmonization E-6 Guidelines for Good Clinical Practice).
Section I Study Information
Study Title:
IRB Protocol #:
Name of Primary Investigator (PI):
PI Email: PI Phone Number:
Section II Adverse Event Description
Date of event:
Location of event:
Please describe the nature of the adverse event in detail:
How many participants have participated in this study to date?
How many more participants are needed?
IRB Adverse Event Form
Page 2 of 2
IRB-ADF – (10/13)
Have any similar adverse events occurred in this study? Yes No
If yes, describe:
How likely was the adverse event caused by the procedures of this study?
Not Related
Unlikely
Possibly
Probably
Definitely
How was the adverse event handled and the situation resolved?
Describe how you intend to protect future participants from experiencing the same harm:
Page 3 of 3
IRB-ADF – (10/13)
As a result of the event, indicate the modifications you will make to resolve the current issue and/or prevent
similar events from occurring in the future (select all that apply):
Modification to protocol/study procedures
Modification to level of risk
Modification to informed consent form
Provide additional information to participants
Re-consent current participants
Research will voluntarily be placed on hold
Re-training of research staff to prevent future events
No action is planned
Other action planned (describe):
Additional comments:
Section III Certification
I certify that the adverse event information is accurate to the best of my knowledge.
PI name:
PI signature: Date:
Completed IRB Adverse Event Forms should be submitted electronically to IRB@broward.edu.
click to sign
signature
click to edit
Download
Save PDF to desktop
Email
Email completed PDF
Send for Signing
Email for others to sign
Print
Print document
Choose a Field
Click on a field and
select the person that should complete it
Want to add a signature?
You can add a signature field
and assign it to someone else
to sign
Choose a Field
Click on a field and
select the person that should complete it

Irb Adverse Event Report Form (Broward College)

This document is locked as it has been sent for signing.

You have successfully completed this document.

Other parties need to complete fields in the document. You will recieve an email notification when the document has been completed by all parties.

This document has been signed by all parties.

Completed 18 August 2020

Message

View Audit Log
Print With Audit Log
Duplicate Document