Bellberry provides the following documents relating to applications that involve radiation:
BA G13 Ionising Radiation
This guidance outlines the requirements where research applications involve the use of ionising radiation.
BA F13.1.1 Standard clauses – ionising radiation
This form provides sites with example clauses for inclusion in the PICF.
If the medical imaging used is the same as standard care.
If extra, study-specific medical imaging is undertaken.
If there are no perceived benefits from participating.
BA F13.1.2 Standard imaging – definitions
This form provides sites with wording to describe different forms of standard imaging for inclusion in the PICF. Imaging covers CT, MRI, and PET scans.
BA F13.1.3 Standard of care declaration – template
Bellberry does not mandate the completion and submission of this form when a PI has made a standard of care declaration in the eProtocol application. If your institution requires the PI to provide a formal notification, please use BA F13.1.3 as a template and place it on your institutional letterhead. This template can be helpful if the PI needs to amend their standard of care declaration during the study.
BA F13.1.4 HREC reporting flowchart – radiation
This form shows the role and relationship between the PI, the HREC and the Medical Physicist when research involves the use of radiation. It also outlines how sites should present the radiation wording to the HREC within all 3 PICF pathways.
Bellberry has also updated the site-specific clauses document (BA F1.1.12) to include examples and a pre-submission checklist. Full details can be found here.
If you have any questions or queries regarding these updates, please contact the Quality Team at bellberry@bellberry.com.au.