Radiology Information

Radiology Trials Process Overview (2020)

Radiology is happy to provide imaging support for research when possible. Below is a guideline on how to most efficiently approach us for support and expedite the process.

Initial Contact

Send a quote request by email to RadiologyTrialsLiaison.SCGH@health.wa.gov.au and provide the following information:

• Trial protocol
• Patient Information and Consent Form - PICF (if available)
• Name of principal investigator
• RGS number
• Proposed start and end dates
• Proposed number of participants
• Summary of imaging requirements (type and frequency)
• Any specific Radiology reporting requirements
• Name of sponsor
• Name of central imaging reviewer (if being engaged)
• Imaging manual (if provided)
• Name of secondary contact persons (when the coordinator position is shared)

Radiology Quote

Radiology will provide a quote to the Principal Investigator and CC the Trial Coordinator. The quote will come from a Clerical Supervisor or from SCGH.RadiologyTrialsBilling@health.wa.gov.au.

In the RGS, Radiology is listed as Radiology. PET and NIISWA are separate departments.

The quoted costs should be entered into the RGS Imaging budget by the Trial Coordinator. Radiology staff generally do not have knowledge of the funding sources which are best filled in by the Research Department.

When imaging fees are waived, they should be listed in full on the funding page as “in kind support”. Partially discounted fees should show the discount as “in kind support” and the balance funded by the sponsor or research department. Example: Departmental Set Up fee of $150.00 discounted from $550.00 is funded “in kind” for $400.00 and by sponsor or department for $150.00.

SSA/Budget

Once the Imaging budget has been completed, send an RGS invitation to approve the budget to Head of Supporting Department (currently Jonathan Tibballs) and to Head of Supporting Department Delegate (currently Roslyn Knight).

Other Considerations

If x-rays are being used in the trial (plain x-ray, fluoroscopy, CT), it is important to answer “Yes” at section 15.4.1 in the SSA. If the imaging is beyond standard care, a Medical Physicist from Medical Technology and Physics (currently Ben Khoo) may need to do dosimetry.

Once Radiology have agreed to support the trial and approved the Imaging Budget, you will be sent a Radiology Trial Number (QETR number). This number must be cited in all imaging request forms related to the trial along with the appropriate clinical history. The trial name is not sufficient clinical history. The QETR number is based on the year the trial was initiated and the last 4 digits of the RGS number (QETRyyyy-RGSnnnn). The QETR number is used to track research activity and is cited in imaging protocols to specify the imaging requirements of the trial.

When the imaging for the trial is not variable, we may create a trial specific request form which will include the Radiology Trial Number.

All contact apart from bookings and invoicing should be made to RadiologyTrialsLiaison.SCGH@health.wa.gov.au. Booking queries can be made to 6457 2233 where they will be appropriately redirected. Invoicing queries should be made to SCGH.CT@health.wa.gov.au.

Requesting Imaging

Imaging request forms should be sent to Chute 17. Interventional examinations must be discussed with an Interventional Radiologist.

Obtaining De-identified Imaging

Queries should be made to RadiologyPACSDesk.SCGH@health.wa.gov.au

Technical Training

When trials require MITs and/or Radiologists to attend training, the time spent on training will be invoiced.

Invoicing

Invoicing queries should be directed to SCGH.RadiologyTrialsBilling@health.wa.gov.au

Radiological Council Review for Research Imaging above Standard of Care

Note: Dosimetry is done only for above standard of care imaging procedures.

Radiological Council Review Criteria

A project must be submitted to the Radiological Council for approval of the radiation aspect if any of the dose levels below are exceeded. The dose levels listed below are for dose received from examinations that are additional to standard of care and apply across the life of the study.

Adults:

• Total effective dose of 20 mSv or greater
• Equivalent dose of 200 mSv to skin, averaged over 1 cm², in a year
• Equivalent dose of 50 mSv to the lens of the eye in any year
• Equivalent dose of 100 mSv to any other organ or tissue in any year

Children (< 18 yrs):

• Total effective dose of 0.5 mSv in any year with 5 mSv total to age 18 yrs
• Effective dose from conception to birth 0.1 mSv
• Total equivalent dose of 100 mSv to any organ or tissue to age 18 yrs

In the first instance to obtain advice and support please contact:

Ben Khoo
Medical Physics Specialist
Sir Charles Gairdner Hospital
Medical Technology and Physics
G Block Ground Floor
(08) 6457 4283
Ben.khoo@health.wa.gov.au

Externally Funded Trials

Medical Technology and Physics (MTP), SCGH will apply the following dosimetry service charges for externally funded trials.

• $270 if study/trial does NOT go to Radiological Council (dosimetry report)
• $441 if study/trial does go to Radiological Council (dosimetry report + assistance in Radiological Council application & submission)

Radiological Council sessions are held once a month and require an application submission separate to the Ethics and Governance submissions.