Guidelines, tools and training

What are Ionising Radiation Procedures?

Ionising radiation procedures are:

• Radiotherapy
• Diagnostic imaging: e.g. CT scans (including CT guided biopsies), DEXA scans, x-rays, fluoroscopy (e.g. PICC line insertion under fluoroscopy guidance), OPG and Angiography
• Nuclear medicine: all scans, including Positron Emission Tomography (PET) and Gated blood pool scans (MUGA)

NOTE: Magnetic Resonance Imaging (MRI) is a non-ionising radiation procedure and does not require a radiation safety risk assessment.

Only ionising radiation exposure additional to standard of care is assessed by an approved medical physicist.

What is required to be submitted for HREC review?

If the radiation exposure is Standard of Care

It is the responsibility of the trial site Principal Investigator to determine if radiation required for the trial forms part of standard of care for participants. If you are unsure please seek advice from Alex Merchant, Barwon Health Medical Physicist.

If the use of ionising radiation exposure is deemed standard of care, the site Principal Investigator completes a HREC Radiation Notification Letter (click to download). The letter must be provided to the Coordinating Principal Investigator for inclusion in the ethics application.

The HREC Radiation Notification Letter must be submtted to the HREC for review (signed by Principal Investigator) via ERM (Ethical Review Manager)

If the radiation exposure is additional to Standard of Care

For Single site studies: The PI must submit an independent radiation safety risk assessment by a Medical Physicist for review by the HREC in ERM.  The assessment must include the effective dose, relevant organ doses, a risk assessment, and recommended text for the PICF.

For multi site studies: All sites must undergo an independent radiation safety risk assessment. However, the Coordinating PI only needs to submit one radiation safety risk assessment for the entire study for review by the HREC in ERM. Ideally this should be the highest site assessment dose available. The assessment must include the effective dose, relevant organ doses, a risk assessment, and recommended text for the PICF.

Both the Medical Physicists Risk Assessment Form (completed by the Investigator) and the Independent Radiation Risk Assessment Report from the Medical Physicist are required for submission to Barwon Health HREC. Other HRECs may request both, or the Report only.

What is required for Governance review?

For single site studies: Please upload the HREC Radiation Notification letter (if Standard of care) or HREC approval and corresponding Radiation risk assessment (if additional to Standard of care) in ERM.

For multi site studies: Please upload the HREC Radiation Notification letter (if Standard of care) or site specific independent radiation safety risk (if additional to Standard of Care) in addition to the HREC approval. 

If the radiation risk category is the same or lower than the risk category listed on the approval certificate, the site radiation exposure can be accepted.

If the site radiation risk category is higher than specified on the HREC approval, the site PI should seek additional HREC approval through the CPI and central HREC.

How to submit a Radiation Safety Risk assessment form

The Site Principal Investigators should submit a site Victorian Medical Physics Risk Assessment Form to the site Medical Physicist at Barwon Health – ensure section 1.1 to 1.6 is completed prior to submission. 

Download the form here: Medical Physics Risk Assessment Form 

The Medical Physicist completes the assessment report using the same form, and this assessment report must be provided to the Coordinating Principal Investigator for inclusion in the ethics application.

The site assessment report must also be provided in the relevant site governance submission to RDU as an attachment to the SSA in ERM.

A second medical physicist report may be required for verification of the expected dose or if the dose of radiation is above the dose constraint