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Initial Considerations

This guide describes the process & steps needed to request a REDCap, CFR Part 11 Validated project.

Part 11 Compliance enforces provisions which requires that:

  • Study personnel develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks.

  • Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures

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.

  • 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

The Process

  1. Register project in: Protracks System

  2. Select the below services:

    1. Biomedical Informatics Core (REDCap Project Request)

    2. Biomedical Informatics Core (21 CFR Part 11 Validated Request)

  3. 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):

    1. CTSI Services Requested

    2. CTSI Project

    3. BMIC Project Information

  4. 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

  5. The BMIC team will then review your request & schedule a meeting to proceed

  6. Upon completion of meeting, 2 survey(s) will be sent to study personnel for completion:

    1. Work-auth form to capture details for flat fee / project build (as applicable)

    2. PI sign-off & acknowledgement of REDCap Validated instance requirements & approval of project recharge fees

  7. 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):

    1. Approve creation of study teams Validated Developmental project

    2. Proceed with next steps for [BMIC built] project

Additional Considerations

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

  • NOTE: The PI and Study Coordinator emails provided within the Protracks registration forms will be used to send important notices regarding Validated features / functionalities as they are released or critically changed

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