Safety reporting

Effective 1 November 2017, important changes were made to the safety monitoring and reporting requirements of research projects. These changes are consistent with the NHMRC's most recent guidance on safety monitoring and reporting in clinical trials involving therapeutic goods.

The following link will provide more information and a detailed map of the new reporting pathways. SCHN Research Ethics and Governance Office has applied these reporting pathways to all types of research projects.

Please use these SCHN specific reporting form templates for the reports outlined in the above link:

• Frequently asked questions
• SSI Notification Form
• Annual Safety Report Form
• SUSAR-USADE-URSAE Notification Form
• SCHN Procedure Clinical Trials – Safety Reporting
• SCH Radiation Safety Report Application Form

• CHW Radiation Safety Report Application Form

Important Information for Radiation Dosimetry Reports:

For submissions requiring Medical Physicist/Radiation Safety Officer review must be submitted via email to SCHN-CHW-RadiationSafetyOfficer@health.nsw.gov.au using the declaration form on the SCHN Ethics/Governance websites. There is a fee ($250 per report) associated with the generation of these reports as an external consultant is required.

• Please allow up to 1 month for the review and generation of a radiation dosimetry report from the date of your submission. If the report needs an independent review due to exceeding the dose constraints, please allow additional time.

• The following documents listed below must be submitted with this request form. The request will not be processed until all of the relevant documents are received:

                    i.            Study Protocol

                  ii.            Imaging Manual (if available)

                iii.            Medical Physicist radiation report from lead site* (if CHW not lead site)

                iv.            Participant and Information Consent Forms (PICF)