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Defence Health

Australian Defence Human Research Ethics Committee

Progress & Final Reports and Adverse Events


Progress & Final Reports

Progress Reports

In accordance with Chapter 5.5 of the National Statement, ADHREC monitors approved research to verify that the research conforms to the approved proposal.

ADHREC requires six-monthly progress reports from all researchers to be submitted on the 1 June and 1 December each year until completion of the research project. Progress reports are to be submitted on the approved pro forma. (Research Project Progress Report)

Progress reports and any attachments are to be PDF’d into a single document and sent under a covering email to the ADHREC Inbox (ADHREC@defence.gov.au).

What happens next?

  • You will receive an acknowledgement that your progress report has been received.
  • The report will be reviewed by the ADHREC Executive Officer and the Director, Defence Health Research.
  • If areas of concern are identified further clarification may be required or advice will be sought from ADHREC.
  • A response email will be sent along with notification of your next due progress report.

For further reporting requirements see Health Manual Volume 23 Chapter 5 Monitoring of human research.

Final Reports

A final report is required on completion or abandonment of a research project. The first page is to be a summary of the overall project such that it could be used for reporting purposes or to provide an overview to other stakeholders (e.g. clinical or health personnel). Final reports are to be submitted on the approved pro forma.(Research Project Final Report)

Final reports and any attachments are to be PDF’d into a single document and sent under a covering email to the ADHREC Inbox (ADHREC@defence.gov.au).

What happens next?

  • You will receive an acknowledgement that your final report has been received.
  • The report will be reviewed by the ADHREC Executive Officer and the Director of Defence Health Research.
  • A completion letter will then be sent finalising your study.
  • Your protocol will then be closed.

For information on final reports and publication see Health Manual Volume 23 Chapter 5 Monitoring of human research.


Adverse Events & Serious Adverse Events

Adverse Events

An adverse event (AE) is defined as any unfavourable or unintended sign, symptom or disease temporarily associated with the use of an investigational product, whether or not related to the investigational product.

When do I need to advise ADHREC of an AE?

AE’s are to be reported to the ADHREC Executive Officer (ADHREC@defence.gov.au) within 30 calendar days on the Adverse and Serious Adverse Event Form. A summary of the AE is also to be included in the Progress Report (for that period) and as part of the Final Report (at the closure).

What happens next?

The AE Report will be reviewed by the Director, Defence Health Research or delegate, and where concerns are raised, escalated to the ADHREC for further advice

Serious Adverse Events

A serious adverse event (SAE) or reaction is any untoward medical occurrence occurring during a human research study that:

  • is fatal,
  • is life-threatening,
  • requires or prolongs hospitalisation,
  • is disabling or incapacitating, and/or
  • is associated with congenital abnormality or a birth defect

When do I need to advise ADHREC of a SAE?

SAE’s are to be reported to the ADHREC Executive Officer (ADHREC@defence.gov.au) within 72 hours of occurrence using the Adverse and Serious Adverse Event Form. A summary of the SAE is also to be included in the Progress Report (for that period) and as part of the Final Report (at the closure).

What happens next?

  • The SAE will be circulated to the committee and chair for review.
  • ADHREC may require that the research be suspended until such time that it is satisfied that it is safe to continue the trial.
For further information and reporting requirements see Health Manual Volume 23 Chapter 5 Monitoring of human research.


Suspension or Cessation of Research

National Statement 5.5.6 states - Researchers should inform the relevant institution/s, the review body/ies that approve the research and, wherever possible, the research participants, if the research project is to be discontinued before the expected date of completion, and why.

A condition of ADHREC approval is that researchers advise the committee in writing if they intend to suspend or cease their approved research, in accordance with the requirements of the National Statement (see above).

Processes for ADHREC initiated suspension or withdrawal of ethical is contained in Health Manual Volume 23 Chapter 5 Monitoring of human research.