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Initial Considerations
This guide describes the process & steps needed to request a REDCap, CFR Part 11 Validated project.
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The project PI is responsible for ensuring both the above requirements are met throughout the life of their study. |
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Cost Factors
Note: There is a fee associated with use of REDCap CFR Part 11 Instance.
Self-built Validated projects require a flat-fee journal entry
Validated projects which will be built by the BMIC team required the flat-fee charge, plus additional project build fees
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The Process
Register project in: Protracks System
Select the below services:
Biomedical Informatics Core (REDCap Project Request)
Biomedical Informatics Core (21 CFR Part 11 Validated Request)
To complete the initial registration process for [validated projects] there will be total of 3 ProTracks forms which need completed (they will sequentially appear in the ProTracks registration process):
CTSI Services Requested
CTSI Project
BMIC Project Information
Upon selection of [21 CFR Part 11 Validated] service, a BMIC help ticket will be autmatically automatically generated for your project in the BMIC REDCap Service Desk
The BMIC team will then review your request
, and if all forms are adequately completed, a survey will be sent to the PI for acknowledgement of use of Validated instance and& schedule a meeting to proceed
Upon completion of meeting, a 2 survey(s) will be sent to study personnel for completion:
Work-auth form to capture details for flat fee / project build (as applicable)
PI sign-off & acknowledgement of REDCap Validated instance requirements & approval of project recharge fees.
Once After PI Sign-Off is captured, the BMIC team will communicate with key personnel using the BMIC help Help ticket to proceed perform the below tasks (as applicable):
Approve creation of study teams Validated Developmental project
Proceed with next steps for [BMIC built] project
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Additional Considerations
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In the event the projects assigned PI or Study Coordinator changes throughout the course of a Validated project, it is the PI’s responsibility to communicate this update to (cctshelpdesk@umail.utah.edu) in order for the Protracks CTSI project registration to be updated accordingly
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