Business Requirements
- Research teams using a new medical device in their clinical research must complete and submit the New Medical Device form to Clinical Engineering for review prior to the study being submitted for IRB-HSR approval.
- The Coordinator will be able to upload one or more approved New Medical Device forms.
Protocol Builder Interface
This workflow relies on the presence of the New Medical Device Form document on the PB coversheet.
CRC1 Stats
~9% (59/660) of studies require IBC Number since the beginning of 2020
Study Dashboard Menu Dependencies
This workflow is part of the Coversheet Documents workflow and will be required if the New Medical Device document is on the PB Coversheet.
Workflow Description
The Coversheet Documents workflow starts by loading the IRB Documents. The New Medical Device Form workflow is one of the available options if the New Medical Device Form document is on the PB Coversheet and will follow the Yes flow arrow out of the New Medical Device Form required? Exclusive Gateway. If the New Medical Device Form 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.
The workflow then allows the Coordinator to upload one or more approved New Medical Device forms and any supporting documents.
Generated Documents
No documents are generated from this workflow.