Periodic Safety Update Reporting Form

Use this form to submit safety summaries generated by sponsors of clinical trials.
To be completed by Research Ethics Office / Date Received:
Research Study
REB File No. / Protocol Identifier
(if applicable)
Title of Protocol
Sponsor
Principal Investigator (PI)
Name
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.
  • Highlight all changes on amended documents. ‘Track changes’ versions will not be accepted.
  • Print this form as a single-sided document. Submit one copy along with one copy of each proposed / amended document to the address listed at the top of this form.
Note: Incomplete submissions will not be processed and will be returned to sender
Periodic Safety Update Reports (PSURs):
  • Periodic safety update reports are sponsor-provided compilationsof new safety information issued at defined intervals (typically quarterly, semi-annual, or annual) with a summary highlightingany main points of concern and the evolving safety profile of the product.
  • Theseupdates are to be submitted to the REB within two months of receipt from the sponsor.
  • Be sure to communicate pertinent information to all affected parties (e.g., subinvestigators, Pharmacy).
  • Participants must be informed in a timely manner if new information becomes available that may affect their willingness to continue in the study. Current participants may be informed with an amended consent form / addendum or, when appropriate, by phone, letter or email.
  • Use the Amendment Form to submit amended consent forms / addendums and the Supporting Materials: Update Form to submit other types of participant information to the REB.
  • If changes are required to the protocol, submit the amended documents using the Amendment Form.
  • If the study will be terminated early, submit the Premature Termination Reporting Form without delay.

Note: Since February 2011, the REB has accepted summary reports only. Reports of individual serious adverse reactions experienced by non-local participants will not be processed and will be returned to the research team.
Section A: Attached Documents
Title of Periodic Safety Update Report / Reporting Period
(e.g., Jan-Mar 2011) / Document Date
(yyyy/mm/dd)
1
2
3

Signature Page

Periodic Safety Update Reporting Form

Research Study
REB File No. / Protocol Identifier
(if applicable)
Principal Investigator’s Signature
Signature: / Date:
(Principal Investigator) / (yyyy/mm/dd)
Research Ethics Board Use Only
The Nova Scotia Health Authority REB acknowledges receipt of the safety information described in this Reporting Form.
Is referral to the REB Executive Committee recommended? Yes No
Signature: / Date:
(Chair/Co-Chair, REB) / (yyyy/mm/dd)
Print Name:
(Chair/Co-Chair, REB)
Processed by: / Date Processed (yyyy/mm/dd)

Page 1 of 3Periodic Safety Update Reporting FormREB Version: 2015/04/01