EASTERN HEALTH RESEARCH AND ETHICS COMMITTEE

SAFETY REPORTS AND NOTIFICATION FORM

Please use this form for the submission of ALL safety reports and notification including:

·  suspected unexpected serious adverse reactions (SUSARs) periodic reports/listings

·  periodic SAE listings

·  data safety monitoring board (DSMB) correspondences

Exception: Please use the alternative form for the reporting of Eastern Health local SAEs

Submit a hard copy and e-files. Hard copy of global SUSAR listings will be returned to you after review.

To: Office of Research and Ethics

Level 2

5 Arnold Street

BOX HILL VIC 3128

Ethics Committee Reference Number:

Project Title:

Principal Researcher/s: / Study Coordinator/s:
Department:

Please enter all documents enclosed in the below table. See examples. Insert as many rows as required.

Eg. DSMB letter dated 01 July 2008, SUSAR quarterly listings, SAE annual summary etc.

Researcher should request summaries of SUSARs and SAE listings from sponsors as far as possible. If no summaries or listings are available please enter details of individual reports in the table below.

Event
Date / Report number / Description of Event / Location / Unrelated / Possibly Related / Probably Related / Definitely Related

Individual safety reports are not required to be submitted routinely but should be available on request.

I recommend the following:

·  Change to protocol Yes * No

·  Change to the Participant Information & Consent Form Yes * No

·  Previously enrolled participants to be notified Yes No

·  The study to be stopped Yes No

·  Action Yes No

* If a change is required to the protocol and/or participant information & consent form, please complete a “Request for Approval of Amendments” form and submit copies of amended documentation as required.

Principal Researcher’s Comments: (Please provide a comment as to whether the events affect study conduct or research participants in any way.)

Principal Investigator: Date

March 2013