Fillable HSC Adverse Event Report Form (Idaho State University)

Fill Online, Printable, Fillable, Blank HSC Adverse Event Report Form (Idaho State University) Form

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

HSC Adverse Event Report Form (Idaho State University)

On average this form takes 6 minutes to complete

The HSC Adverse Event Report Form (Idaho State University) form is 3 pages long and contains:

  • 0 signatures
  • 0 check-boxes
  • 23 other fields

Country of origin: US
File type: PDF

U.S.A. forms for Idaho State University

BROWSE IDAHO STATE UNIVERSITY 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
 
Idaho State Univeristy
Human Subjects Committee
Mail Stop 8130
Adverse Event Report
All incidents of injury or other adverse effects by subjects in research must be reported to the HSC. This report
should be submitted as soon as possible, but NO LATER THAN 5 WORKING DAYS after the first awareness of the
problem. The investigator should provide his/her opinion and support for any proposed changes in the protocol
and/or consent form or procedure.
Date of Report Date of Event Date PI learned of event
Protocol Information
Principal Investigator
Title of Project
HSC # Date Originally Approved
Is this a multi-center research project ?
If Yes, give home IRB
and phone /address
Did the adverse event or incident involve the ISU arm of the multi-center research?
Does the proposal involve an FDA approved IND or IDE? Provide the IND or IDE Number
Provide the name of the drug or device
Adverse Event Information
Did the adverse event and/or involve the drug or device?
Did the adverse event and/or incident involve a research procedure?
Was the drug/device/procedure intended to directly benefit the subject?
Was the effect described in the IND or IDE information? Has the home IRB been informed of the adverse event?
Has the off-campus site director been informed of the adverse event?
Was the effect listed in the risks section of the protocol?
Was the effect listed in the informed consent document?
How many subjects are to be enrolled in this research project?
How many subjects have been enrolled to date?
How many adverse events reports have been filed with the HSC on this project?
Date of Event
The adverse event was:
The adverse event was:
Page 1 of 3
Comments:
Print Form
Submit by Email
Page 2 of 3
Description of Adverse Event
Provide a brief description of the adverse event, including the subject's demographic information.
Date of Treatment
The subject's recovery was:
Treatment Provided to the Research Subject
Describe the treatment that was provided to the subject.
Is a change in the protocol necessary to reduce or eliminate the possibility of a reoccurrence of this event in other
subjects:
Please provide a rationale for not changing the protocol.
Please provide a rationale for not changing the consent document or process.
Change Necessitated by Adverse Event
Are changes required in the informed consent process or document?
Is it necessary to re-consent subjects who have not completed all the research procedures?
If YES, explain how the re-consent process will be accomplished.
Page 3 of 3
Changes to Protocol Necessitated by Adverse Event
If NO, provide a rationale for not re-consenting subjects.
Please provide any additional information you feel would be helpful to the HSC in assessing this adverse event.
HSC Initials
__________________________________
Date ____________________________________
Full Board ___________
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

HSC Adverse Event Report Form (Idaho State University)

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 26 July 2020

Message

View Audit Log
Print With Audit Log
Duplicate Document