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Initial Considerations
This guide describes the process & steps needed to request a REDCap, 21 CFR Part 11 Validated project.
21 CFR Part 11 Compliance enforces provisions which requires that:
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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 for a 21 CFR Part 11 Instancevalidated project instance whether you build the project on your own or if BMIC project assistance is needed.
Self-built Validated projects require a flat-fee journal entry
Validated projects which will be built by the BMIC team required require the flat-fee charge, plus additional project build fees as determined by a statement of work and project design.
Projects NOT requiring 21 CFR Part 11 compliance under FDA regulations or sponsors requirements do not have this associated fee and should not be requested as a 21 CFR Part 11 REDCap project.
For instance if your general research project is using econsent for non-FDA regulated study and has no sponsor requirements for 21 CFR Part 11 compliance, no additional validation fee is required.
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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 automatically generated for your project in the BMIC REDCap Service Desk
The BMIC team will then review your request & 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
After PI Sign-Off is captured, the BMIC team will communicate with key personnel using the BMIC Help ticket to 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@umailredcap@ccts.utah.edu) in order for the Protracks CTSI project registration to be updated accordingly
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