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For IRB internal use only:

Reportable Events Form

Events that are unanticipated and increase the risk to subjects or others, which may significantly affect the conduct of the
clinical trial, could affect a participant’s willingness to continue in the study, or could be noncompliance, must be reported
to the IRB. Please refer to the Sterling IRB Investigator Handbook for additional information regarding reportable events.
NOTE: Reportable events should be submitted to Sterling IRB within 10 business days of when the site became aware of
the event. Reportable events that are fatal or life threatening should be reported immediately.

STUDY INFORMATION

Sterling IRB ID#: Protocol:

           
Principal Investigator, if applicable: Sponsor:
           

REPORT INFORMATION

Date of event/onset: Date site became aware of Initial Follow-up       Has Sponsor been notified of
mm/dd/yyyy event: mm/dd/yyyy F/U # the event? Yes No
Date Unknown Date Unknown

Status of Event, if applicable:

Ongoing Resolved Date Resolved: mm/dd/yyyy Date Unknown

PARTICIPANT INFORMATION (if applicable)

Subject ID #:       Subject Age:       Male Female

Is this subject still enrolled in the study? Yes No

EVENT INFORMATION

Please select the type of event from the options listed below:

Internal adverse event (“SAE”)

Is the internal adverse event (a)unexpected; (b) related or possibly related to participation in the research; and (c)
serious?:
Yes *No
*If no, this event is not reportable and does not require submission to Sterling IRB.

External adverse event (“IND Safety Report”)

Is the external adverse event an event that may, in the opinion of the Sponsor/CRO/SMO or Principal
Investigator, represent an unanticipated problem involving risks to subjects or others?:
Yes *No
*If no, this event is not reportable and does not require submission to Sterling IRB.

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 Significant deviation
Does this significant deviation (1) affect the rights, safety, or welfare of study subjects; (2) change the
risk/benefit ratio; (3) affect the scientific design of the study; or (4) violate an ethical principle?:
Yes *No
*If no, this event is not reportable and does not require submission to Sterling IRB.
Significant Deviation noted by: Investigator/Site Monitor Other:      
State medical board or federal agency action (e.g., Form FDA 483, FDA Warning Letter, NIDPOE,
medical license action, medical board order or consent agreement)
Audit Documentation (including response from the PI/site and any follow-up correspondence from the regulatory
agencies): Attached Currently unavailable, but will submit upon receipt
Other reportable event (only check one):
New or increased risk or other Unanticipated Problem
Any event that requires prompt reporting according to the Sponsor
Other (please describe):      
Is the event (a) unexpected; (b) related or possibly related to participation in the research; and (c) an event
that suggests that the research places subjects at a greater risk of harm than was previously known or
recognized?:
Yes *No
*If no, this event is not reportable and does not require submission to Sterling IRB.
NOTE: Please refer to Sterling IRB’s Investigator Handbook and Events Reportable to the IRB guidance for other reportable
events and examples of possible unanticipated problems.

Please describe the event (Attach a separate page if necessary) - For significant deviations, please include the
reason for the event:
     

Have any corrective or other actions been proposed or taken in response to the event?* Yes No

*If yes, please describe the corrective or other actions that are proposed or that have been taken in response to the event:
     
*If no, please justify why corrective or other actions are not being taken:      

Are you proposing any changes to the IRB approved protocol and/or informed consent form? Yes* No
*If yes, please attach proposed changes. Any changes to the informed consent document must be clearly marked.

Does this event affect the rights, safety or welfare of subjects? Yes No
Does this event affect the integrity of the study data? Yes No

I, the submitting party, attest that the information provided above is true and accurate and is submitted by, or
under the authority of, the Principal Investigator or Sponsor.

                                                   
Name of Person Completing this Form Date

                                    
Phone Number E-mail Address
Please complete this form and submit via SilverLink, email, or fax.

For IRB internal use only:

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