Clinical Trials Safety Reporting Guidelines

Cinicial Trials with Investgational Medical Products

If the you are conducting clinical trial with an investigational medical product 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 Events

Adverse Reactions

Serious Adverse Events

Serious Adverse Reactions

CPI or PI Sponsor: Research Ethics Compliance Support Office  24 hours of becoming aware of the event.

Serious Unexpected Serious Adverse Reaction

CPI or PI Sponsor: Research Ethics Compliance Support Office 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 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 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 as required by the HREC

Protocol Deviations CPI or PI Sponsor: Research Ethics Compliance Support Office 24 hours of becoming aware of the event

Serious Breach of Protocol

CPI or PI

Sponsor: Research Ethics Compliance Support Office

24 hours of becoming aware of the event

 

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Safety Monitoring Reporting Time frames where UNSW is not the Sponsor

Type of Event

Who Reports

To Who

How

When

Adverse Events

Serious Adverse Events

Serious Adverse Reactions

Adverse Reactions

CPI or PI to the Sponsor The reviewing HREC

The CPI or PI immediately or within 24 hours of becoming aware of the event.

The sponsor report a line listing summary of adverse events to the reviewing HREC on an annual basis. 

Serious Unexpected Serious Adverse Reaction

CPI, PI reports to the Sponsor The reviewing HREC (and all investigators participating in the study.

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.

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.

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.

Investigator’s Brochure Updates/Addenda

CPI or PI

The reviewing HREC.

  • Submitted with a Cover Sheet

As and when generated.

Annual safety report

CPI or PI

The reviewing HREC.

  • The reviewing HRECs Annual Progress Report Form.

Annual as required by the HREC.

Protocol Deviations CPI or PI UNSW RECs Office
  • The CPI or PI immediately or within 24 hours of becoming aware of the event.

Serious Breach of Protocol

CPI or PI

The reviewing HREC.

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. 

 

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Safety Reporting Definition

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 Reaction (AR): 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 is related to the investigational medical product.

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.

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Safety Reporting Assessments

Adverse Events

All reports are submitted as adverse events. Once submitted it is the sponsors responsibility to assess the report in accordance with the protocol to determine the seriousness/causality/expectedness of the adverse event.

  • Adverse Event (AE): If the event is “not serious” and "not related: to the investigational medical product it is categorised as an AE.
  • Adverse Reaction (AR): If the event is “not serious” and “related” to the investigational medical product it is categorised as an adverse reaction.
  • Serious Adverse Event (SAE): If the event is “serious” and “not related” to the investigational medical product it is categorised as an SAE.
  • Serious Adverse Reaction (SAR): If the event is “serious” and “related” to the investigational medical product and is expected (expected being it is listed in the trials safety information (current investigator brochure or the investigational product information) it is categorised as a SAR.
  • Suspected Unexpected Serious Adverse Reaction (SUSAR): If the event is “serious” and “related” to the investigational medical product and is unexpected (unexpected being it is not listed in the trials safety information (current investigator brochure or the investigational product information) it is categorised as a SUSAR.

Serious Breaches

All suspected serious breach reports are submitted to the sponsor. The sponsor will liase with the CPI, PI and the Data Safety Monitoring Board to assess whether the breach of Good Clinical Practice or Protocol is likely affect (a) The safety or rights of a trial participant or; (b)The reliability and robustness of the data generated in the clinical trial. 

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Protocol Deviations
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