Business Requirements
- If a study involves an Imaging Procedure that is listed below, the Coordinator may insert the approved language for each selected procedure.
- If the selected procedure used in the study follows the exact wording provided, the protocol and consent form will NOT need to be reviewed by the Radiation Safety Committee Subcommittee (HIRE - Human Investigations Involving Radiation Exposure).
- Include the selected procedures reviewed and confirmed exact wording provided in the study review submission to the IRB-HRS.
- All other language will need to be reviewed & approved.
Protocol Builder Interface
This workflow is required when the HIRE Standard Radiation Language document is on the PB Coversheet.
CRC1 Stats
This workflow does not have any CRC1 stats.
Study Dashboard Menu Dependencies
This workflow is part of the Coversheet Documents workflow and will be required if the HIRE Standard Radiation Language document is on the PB Coversheet.
Workflow Description
The Coversheet Documents workflow starts by loading the IRB Documents. The Standard Radiation Language workflow is one of the available options if the HIRE Standard Radiation Language document is on the PB Coversheet and will follow the Yes flow arrow out of the Standard Radiation Language required? Exclusive Gateway. If the HIRE Standard Radiation Language document is not on the PB Coversheet, the No flow arrow will be followed and the workflow will not be in shown as an option.
If in the PB Coversheet, a script task checks to see if the workflow was restarted and if so, the previously uploaded file is deleted.
Next the Select Standard Radiation Language User Task allows the Coordinator to select from a group of CT and XRay procedures, as well as if Fluoroscopy, Nuclear Medicine and Non-Ionizing Radiation studies will be included in the study. Once the selections are made and the Coordinator clicks the Save button, a Word document with the approved language is generated and uploaded. The Coordinator can then download it from the Document Pane, review and if necessary, select the completed workflow and adjust as needed.
Documents
The Ionizing Radiation Consents document is produced from this workflow and automatically uploaded.