Nova Scotia Health Authority Research Ethics Board
Centre for Clinical Research, Room 118
5790 University Ave., Halifax, NS B3H 1V7
Phone: 473-2126
Fax: 473-5620
Local Serious Unexpected Adverse Reaction:
Initial Report
Use this form to submit serious unexpected adverse reactions experienced by local participants during a research study.
To be completed by Research Ethics Office
Date Received:
Research Study
REB File No.
Protocol Identifier
(if applicable)
Title of Protocol
Principal Investigator (PI)
Name
Supervising Investigator (SI)
Not applicable
Name
Mailing Address
Phone No.
Fax No.
Email Address
Person to whom Correspondence should be Sent
Name
Study Role
Mailing Address
Phone No.
Fax No.
Email Address
Instructions:


Mailing address must be detailed enough to enable successful delivery of return correspondence. Specify department /
division / program / service, institution, building, and room number as well as any other required information.
Print this form as a single-sided document. Submit one copy to the address listed at the top of this form.
Note: Incomplete submissions will not be processed and will be returned to sender.
Local Serious Unexpected Adverse Reactions:

Local participant: A research participant enrolled by the investigator at one or more centres under the jurisdiction of the
Nova Scotia Health Authority Research Ethics Board (NSHA REB).
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Adverse event: Any untoward medical occurrence experienced by a research participant.
Serious unexpected adverse reaction (SUAR): An adverse event that is ‘serious’ (see Section 6) and ‘unexpected’
(Section 7) and related or possibly related to participation in the research (Section 8). Adverse events that do not meet
all three of these criteria are not SUARs and should not be reported to the REB.
SUARs experienced by local participants are to be reported to the REB within 7 days of the research team’s awareness
of the event, even if full details are not yet known.
SUARs should also be reported to the study sponsor, as sponsors are responsible for submitting safety information to
applicable regulatory authorities (e.g., Health Canada) in accordance with regulatory requirements. If the study is
funded by a US Department of Health and Human Services agency (e.g., NIH, NCI), the sponsor is asked to report the
SUAR to the applicable agency head (or designee) and the Office for Human Research Protections on behalf of the
institution.
Use the Local Serious Unexpected Adverse Reaction: Follow-up Report to submit new or modified information to the
REB. Follow-up Reports are to be submitted until the event resolves.
Serious Unexpected Adverse Reaction
1
Affected participant
Subject no.:
2
Event / diagnosis
3
Start date
(yyyy/mm/dd)
4
Date the research team
became aware of the event
(yyyy/mm/dd)
5
How did the research team become aware of the event?
Initials:
Not known
Reported by the participant
Reported by another health care provider
Noted during chart review
Discovered by the monitor / sponsor representative
Other: (specify)
6
Seriousness: Which of the following criteria apply to the event?
If the event does not meet any of these criteria, it was not ‘serious’ and should not be reported to the REB.
Resulted in death
Life-threatening
Resulted in a persistent or significant disability / incapacity
Required inpatient hospitalization or
prolonged existing hospitalization
Congenital anomaly / birth defect
Important event that jeopardized the participant or required intervention to prevent one of the above
7
Expectedness: Are the nature, severity and frequency of the event consistent with the risks described in
the study protocol, consent form and applicable product information?
If the nature, severity and frequency of the event are consistent with the risks described in these documents,
the event was ‘expected’ and should not be reported to the REB.
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No, the event was ‘unexpected” (it was an ‘unanticipated problem’)
Causality: Was the event caused or exacerbated by study procedures?
8
If neither the investigator nor the sponsor believes that the event may have been caused or exacerbated by
study procedures, it was not a ‘reaction’ and should not be reported to the REB. Events should only be
reported if the investigator and/or the sponsor believes that the event was related or possibly related to study
participation.
Investigator’s opinion:
Related
Possibly related
Unrelated
Sponsor’s opinion:
Related
Possibly related
Unrelated
9
Outcome of the Event
Event ended on (date):
(yyyy/mm/dd)
And the participant:
Event is ongoing
Submit Follow-up Reports until the event resolves.
Recovered completely
Recovered with sequelae
Died
10
Pending
Unknown
Submit Follow-up Reports as information becomes
available.
Action(s) planned / taken to address this event:
(e.g., study procedures suspended, participant withdrawn from the study, no action)
Action(s) planned / taken to reduce the likelihood of the event happening again:
(e.g., study protocol and/or consent form to be amended, study to be closed, no action)
11
 If changes are required to the EAS Form, protocol or consent form, submit the amended document(s) using the
Amendment Form. Use the Supporting Materials: Update Form to submit other types of participant information.
 If the study will be terminated early, submit the Premature Termination Reporting Form as soon as possible.
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Signature Page
Local Serious Unexpected Adverse Reaction: Initial Report
Research Study
Protocol Identifier
REB File No.
(if applicable)
Serious Unexpected Adverse Reaction
Affected participant
Subject no.:
Initials:
Investigator’s Signature
If the PI is not available to sign this form within the 7-day reporting timeline, a designated subinvestigator (or the supervising
investigator, if applicable) may sign on his/her behalf. The PI should review and countersign the Report upon his/her return.
Principal investigator
Supervising investigator (as listed on page 1 of this form)
Study role:
Subinvestigator (print name):
Signature:
Date:
Research Ethics Board Use Only
The Nova Scotia Health Authority REB has reviewed the serious unexpected adverse reaction described in this
form.
Is referral to the REB Executive Committee recommended?
Signature:
Yes
No
Date:
(Chair/Co-Chair, REB)
(yyyy/mm/dd)
Print Name:
(Chair/Co-Chair, REB)
Processed by:
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Local Serious Unexpected Adverse Reaction: Initial Report
Date Processed (yyyy/mm/dd)
REB Version: 2015/04/01