Initial Considerations
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The project PI is responsible for ensuring both the above requirements are met throughout the life of their study. |
COST FACTORS
Note: There is a fee associated with use of REDCap CFR Part 11 Instance.
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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 opened for supportautmatically 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 PI-Sign-Off form survey will be sent to the PI provided within the ‘Project Information’ form for acknowledgement of use of Validated instance and approval of project recharge fees.
Once PI Sign-Off is captured, the BMIC team will communicate with key personnel using the BMIC help ticket to proceed with next steps
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