Safety Reporting

The Cancer Institute NSW Clinical Research Ethics Committee will receive safety information in accordance with the NHMRC Alert No1, dated 18th April 2007, and the NSW Health Model for Single Ethical and Scientific Review of Multi-Centre Research (SOP 23, August 2007).

Investigators are to complete the Safety Event Reporting Agreement and submit it with their application. Guidance should be sought from the Safety Event Reporting Flow Chart.

Please note safety information reporting in any other form will not be accepted by the Committee.

Safety reporting forms

Annual SAE/SUSAR Summary Report Form

SAE/SUSAR Individual Safety Report Form

All safety reports must be reviewed by the investigator who should determine the relevance of the information to study conduct and provide a comment to this effect in all submissions.

Report any changes that may:

• Increase the risk for participants;
• Affect the safety or health of participants;
• Affect trial conduct.

Report any new information that may:

• Impact on the ethical acceptability of the trial;
• Result in a change in protocol;
• Alter safety monitoring.

Applicants are to use the forms above and provide one (1) soft copy (email) and one (1) hard copy (with original signature) to:

Via Post: Ethics Coordinator, Cancer Institute NSW, PO Box 41, Alexandria, NSW 1435

In Person: Ethics Coordinator, Cancer Institute NSW, Australian Technology Park, Suite 101, 1 Central Avenue, Eveleigh, NSW 2015

Via Email: ethics@cancerinstitute.org.au