Click on the magnifying glass to the right. Starting typing a topic you wish to learn about

Skip to end of metadata
Go to start of metadata

You are viewing an old version of this content. View the current version.

Compare with Current View Version History

« Previous Version 4 Next »

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.

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 forms which need completed:

    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 opened for support

    1. 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

  5. Once PI Sign-Off is captured, the BMIC team will communicate with key personnel using the BMIC help ticket to proceed

Additional Considerations

  • 1

  • 2

  • 3

  • No labels