Download Updated safety information reporting form

For REB Use Only
ST. MICHAEL’S RESEARCH ETHICS BOARD (REB)
UPDATED SAFETY INFORMATION REPORTING FORM
See ‘Guidelines for Reporting Serious Adverse Events/Unanticipated Problems to the SMH REB’ and this
Reporting Form at: http://stmichaelshospitalresearch.ca/staff-services/research-ethics/forms-guidelines/
Handwritten submissions are NOT acceptable
Complete this form and submit two (2) signed hard copies to the SMH REB.
Submissions that are incomplete will be returned to the submitter.
REB #:
Study Title:
SMH Principal Investigator:
Sponsor #:
Definitions:
Periodic Safety Update Report (PSUR): a summary report prepared by the Market Authorization Holder (MAH) that provides a
periodic but comprehensive assessment of the worldwide safety data of a medicinal product. The PSUR can be an important source
for the identification of new safety signals, a means of determining changes in the benefit-risk profile, an effective means of risk
communication to regulatory authorities and an indicator for the need for risk management initiatives, as well as a tracking
mechanism for monitoring the effectiveness of such initiatives.
Investigator’s Brochure: A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the
study of the investigational product(s) in human subjects.
Examples of study safety information include, but are not limited to the following:

Data Safety Monitoring Board (DSMB) Meeting

Summaries


Periodic Safety Update Reports

Revised Investigator’s Brochures


Product Safety Information i.e. Updated Product
Monographs

Safety Alerts


Audit or Monitoring Reports
Interim Study Results during an active trial
Notification of Sponsor suspension or
termination of the study
Changes in Health Canada or FDA labeling or
withdrawal from marketing of a drug, biologic,
natural health product or device used in a
research protocol
Publication in the literature or other findings
Note: This form may also be used to report a summary of any external SAEs/ Serious Unexpected Adverse Drug Reactions (SU-ADRs) that are
issued after the initial ethics submission until prior to REB approval, if these SAEs / SU-ADRs meet the criteria of an unanticipated problem and
require a change to the protocol and/or consent form and/or require immediate notification to research participants for safety reasons.
TYPE of Report:(check all that apply)
Data Safety Monitoring Board (DSMB) Meeting Summary
Periodic Safety Update Report
Includes a summary of all suspected unexpected SAEs that have occurred during reporting period
*Revised Investigator’s Brochure (IB) - Name of Product:
Edition/Version Date:
The updated IB must include a summary and rationale for the changes highlighted before submitting to the REB
Product Safety Information (e.g. updated Product Monograph, Prescribing Information, Instructions for Use)
The updated Product Monograph must include a summary and rationale for the changes highlighted before submitting to the REB
Safety Alert (e.g. black box warning, drug recalls, etc.)
Other, please specify:
*If Research Pharmacy is being used for this study, please ensure that they are provided with a copy of the updated IB.
Date of Report (dd/mmm/yyyy) :
Updated Safety Information Reporting Form
Version Date: 30-Mar-2017
Date SMH Study Team became aware of Information:
(dd-mmm-yyyy):
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Study Status:(check all that apply)
Actively Enrolling
Closed to Enrollment
On Hold
Active Study Participants
Number of Participants Enrolled at SMH to Date:
Number of Participants Enrolled at all sites to Date:
Total Target Number of Participants:
SAFETY MONITORING
YES
NO
Is there an Independent Data Safety Monitoring Board (DSMB) for this study?
If yes, ensure all DSMB Meeting Summaries are submitted as per study protocol to the SMH REB using the Updated
Safety Information Reporting Form.
Describe the impact of the safety information on the study as a whole and the impact (if any) at the local site.
IMPACT ASSESSMENT
Does the Updated Safety Information require change(s) to the study protocol?
YES
NO
If yes, submit the changes using the ‘Amendment and Administrative Change Request Form’.
Does the Updated Safety Information require change(s) to the consent form(s)?
If yes, submit the changes using the ‘Amendment and Administrative Change Request Form’.
Should participants be notified of the Updated Safety Information?
Principal Investigator Comments:
DECLARATION BY PRINCIPAL INVESTIGATOR
I attest that I as the Principal Investigator (PI) have reviewed the updated safety information and its safety implications, assessed the
relationship of the updated safety information to the research study and attest to the accuracy of this report.
I warrant that this study will continue to be conducted in accordance with the Tri-Council Policy Statement Ethical Conduct for
Research Involving Humans (TCPS), the Ontario Personal Health Information Protection Act (PHIPA) 2004, the St. Michael’s
Hospital By-laws, the Catholic Association of Canada Health Ethics Guide, and other relevant laws, regulations or guidelines, [e.g.,
Health Canada Part C, Division 5 of the Food and Drug Regulations, Part 4 of the Natural Health Products Regulations, Medical
Devices Regulations, and ICH/GCP Consolidated Guideline E6].
Printed Name of SMH Principal
Investigator
Date
Signature*
*Original Ink or electronic/digital signature
FOR SMH REB OFFICE USE ONLY
 No further action required
 Further Action Required (select all that apply, and explain):
 Protocol change
 Consent Form change

Other
Explain:
 Yes  No
Full Board Review?
Other Comments:
Printed Name of REB Member
Updated Safety Information Reporting Form
Version Date: 30-Mar-2017
Signature
Date
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