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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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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 forms which need completed:
CTSI Services Requested
CTSI Project
BMIC Project Information
Upon selection of [21 CFR Part 11 Validated] service, a BMIC help ticket will be opened for support
The BMIC team will then review your request, and if all forms are adequately completed, a PI-Sign-Off form will be sent to the PI provided within the ‘Project Information’ form
Once PI Sign-Off is captured, the BMIC team will communicate with key personnel using the BMIC help ticket to proceed
Additional Considerations
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