Transcript Slide 1

Serious Adverse Event
Reporting
Start-up Meeting
March 25, 2010
Kingston, ON
Procedures
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Using Pfizer Products
MUST follow Pfizer SAE reporting policies
SAEs Defined
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Any untoward medical occurrence that at any dose
results in:
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Death
Is life-threatening
Requires in-patient hospitalization or prolongs hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly or birth defect
An important medical event
SAE Manual pg. 4-5
When to report:
Reportable (x)
SAE Criteria
Death
Expected Unexpected
x
x
Life-threatening
x
UNEXPECTED
Hospitalization
x
An
event that is not expected due to the progression
of
underlying disease or co-morbid illnesses.
Disability/Incapacity
x
Congenital anomaly, birth
defect
Important medical event
x
x
SAE Reports to:
Pfizer Canada Drug Safety Group
AND
A copy sent to CERU Project Leader
SAE Manual pg. 7
Reporting Timelines
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From the time the patient receives the first dose
until 28 days following the last dose
Last Dose of
Investigational
Product
Consent
Obtained
28 days post
last dose of IP
Randomization
14 days
28 days
Report all SAEs to Pfizer & CERU
SAE Manual pg. 6
Initial Reports - Timing
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Fatal & Life-threatening: IMMEDIATELY
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All other SAEs: within 24 hours of awareness
of the occurrence of the event
SAE Manual pg. 6
SAE Report Forms
SAE Manual, Appendix A & B
Minimum required information
1. Identifiable Patient
Minimum required information
2. Suspect Product
Minimum required information
3. SAE (diagnosis or signs & symptoms)
Minimum required information
4. Identifiable reporting source
Causality Assessment
A determination of whether or not there is a reasonable
possibility that the blinded therapy is caused or contributed
to the SAE.
YES
OR
•Concomitant medications
•Background treatment
NO
•Comorbidities
•Study procedures
•Other
SAE Manual pg. 7
Follow-up Information
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New, updated or corrected information to a
previously submitted report:
Missing or incomplete info at time of initial report
 Info not previously available
 Changes or clarifications
 Additional information as requested by Pfizer or
CERU
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Site identifies a reportable SAE
Site completes an initial report using
Pfizer SAE Report Form
If event is casually related
to IP, CERU must report to
Health Canada:
Sends report to:
Pfizer AND CERU
YES
Causally related to IP?
YES & NO
Pfizer will correspond with
site until report is
complete
Site reports SAE to local
REB as per local
requirements
•Death or Life-threatening
= 7 calendar days
•All other SAEs
= 15 calendar days
CERU will correspond with
the site until report is
complete.
CERU will send completed
report to all participating
sites. Site to submit to
local REB.
Unblinding
There is no known antidote for the
investigational products
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If there are concerns regarding the
investigational product, stop the product and
complete a Protocol Violation Form
If unblinding is required procedures outlined
SAE Manual pg. 9