Cinicial Trials with Investigational Medical Devices

If the you are conducting clinical trial with an investigational medical device under the Clinical Trial Exemption Schemes (CTX/CTN Scheme) and UNSW is listed as the sponsor on the CTX/CTN Form safety monitoring and reporting must be conducted in accordance with the NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods and with the requirements outlined on this page.

Safety Monitoring Reporting Time frames where UNSW is the Sponsor

Type of Event	Who Reports	To Who	How	When
Adverse Event Adverse Device Effect	CPI or PI	Sponsor: Research Ethics Compliance Support Office	Adverse Event Form	24 hours of becoming aware of the event.
Serious Adverse Events Serious Adverse Device Effect Unanticipated Serious Adverse Device Effect	CPI or PI	Sponsor: Research Ethics Compliance Support Office	Adverse Event Form	24 hours of becoming aware of the event.
Significant Safety Issue (without an Urgent Safety Measure).	CPI or PI	Sponsor: Research Ethics Compliance Support Office	SSI notification form	24 hours of becoming aware of the event
Significant Safety Issue that meets the definition of an Urgent Safety Measure	CPI or PI	Sponsor: Research Ethics Compliance Support Office	SSI notification form	Immediately after an urgent safety measure has been put in place to eliminate an immediate hazard to a participants health or safety.
Investigator’s Brochure Updates/Addenda	CPI or PI	Sponsor: Research Ethics Compliance Support Office	Submitted with a Cover Sheet	Annually with the annual safety report, or as required.
Annual safety report	CPI or PI	Sponsor: Research Ethics Compliance Support Office	Annual Progress Report	Annual as required by the HREC
Serious Breach of Protocol	CPI or PI	Sponsor: Research Ethics Compliance Support Office	Suspected Serious Breach Report Form	24 hours of becoming aware of the event

Safety Monitoring Reporting Timeframes where UNSW is not the Sponsor

Type of Event	Who Reports	To Who	How	When
Adverse Event Adverse Device Effect Serious Adverse Events	CPI or PI to the Sponsor	The reviewing HREC	Adverse Device Event Report Form or the Sponsors Report Form	The CPI or PI must report to the Sponsor and the Site Governance Officer within 24 hours of becoming aware of the event. The sponsor must report a line listing summary of adverse events to the reviewing HREC on an annual basis.
Serious Adverse Device Effect. Unanticipated Serious Adverse Device Effect.	CPI, PI reports to the Sponsor	The reviewing HREC (and all investigators participating in the study.	Adverse Device Event Report Form or the Sponsors Report Form	The CPI or PI must report to the Sponsor and and the Site Governance immediately. The sponsor must report to the reviewing HREC and the TGA immediately but later than 7 calendar days of being made aware of the event.
Significant Safety Issue (without an Urgent Safety Measure).	CPI or PI	The reviewing HREC (and all investigators participating in the study.	SSI notification form or the sponsors report form.	The CPI or PI must report to the Sponsor and the Site Governance immediately. The sponsor must report to the reviewing HREC and the TGA within 15 calendar days of being made aware of the event.
Significant Safety Issue that meets the definition of an Urgent Safety Measure	CPI or PI	The reviewing HREC (and all investigators participating in the study.	SSI notification form the sponsors report form.	The CPI or PI must report to the Sponsor and the Site Governance immediately. The sponsor must report to the reviewing HREC and the TGA within 72 hours of being made aware of the event.
Annual safety report	CPI or PI	The reviewing HREC.	The reviewing HRECs Annual Progress Report Form.	Annual as required by the HREC.
Serious Breach of Protocol	CPI or PI	The reviewing HREC.	Suspected Serious Breach Report Form.	The CPI or PI must report to the sponsor and the Site Governance within 24 hours of becoming aware of the event. The sponsor must report to the reviewing HREC and the TGA within 7 days of confirming that a serious breach has occurred.

Adverse event (AE): Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and that does not necessarily have a causal relationship with this treatment and is not related to the investigational medical product.

Adverse Device Effect (ADE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, whether or not related to the investigational medical device.

Serious Adverse Events (SAE): Any adverse event/adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect and is not related to the investigational medical product.

Serious Adverse Reaction(SAR):Any adverse event/adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect and is related to the investigational medical product.

Suspected Unexpected Serious Adverse Reaction (SUSAR): An adverse reaction that is both serious and unexpected.

Unexpected Adverse Reaction (UAR): An adverse reaction, which is not consistent with the Reference Safety Information (RSI) that is provided in Investigator Brochure or the Product Information Brochure.

Significant Safety Issue (SSI): A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.

Urgent Safety Measure: A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety.

Serious Breach: A breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree:

The safety or rights of a trial participant, or
The reliability and robustness of the data generated in the clinical trial. Note: this guidance's definition of serious breach differs from the definition in the Australian Code for the Responsible Conduct of Research and is about deviations from the requirements of Good Clinical Practice or the clinical trials protocol.

Suspected Breach: A report that is judged by the reporter as a possible serious breach but has yet to be formally confirmed as a serious breach by the sponsor.

PI: The person responsible, individually or as a leader of the research team at a site, for the conduct of a trial at that site. In a single centre trial, the principal investigator may also be the coordinating principal investigator.

CPI: Coordinating Principal Investigator as defined below:

In relation to a clinical trial conducted at a single trial site, the principal investigator at that site
In relation to a clinical trial conducted at more than one trial site, the health professional, whether or not he or she is an investigator at any particular site, who takes primary responsibility for the conduct of the trial.

Site Governance Officer: The person responsible for the governance of the sites where a safety event occurs.

HREC: The human research ethics committee that reviewed and approved the clinical trial.

Sponsor: An individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study.