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This articles describes the steps required for Creation and Validation of a new REDCap Project on the Brain-CODE Instance of REDCap. REDCap project Validation ensures tha t

Project Initiation

  1. Study Initiation:

    1. The Ontario Brain Institute reviews and approves the initiation of a new study

    2. The new study is added to the Brain-CODE Study Metadata Repository (MDR)

  2. REDCap Project Creation:

    1. An Indoc IDP Lead creates the study project on REDCap

    2. The Brain-CODE Subject Enrolment and Informed Consent Form is imported into the REDCap project

    3. Any Brain-CODE Common Data Elements (CDEs) that will be collected by the Study are imported into the new REDCap project

  3. REDCap Project Design:

    1. Additional electronic Case Report Forms (eCRFs) are created or imported by the NI Lead

    2. Any required modifications are made and thoroughly tested by the IDP Neuroinformatics Lead

  4. REDCap Project Submitted for Review:

    1. A request to have the project moved to Production is submitted by the IDP PM or Designer

    2. The Study Protocol, original Case Report Forms (CRFs) and all relevant Informed Consent Forms are sent to OBI and Indoc for review.

Project Validation

  1. Creation Validation: Indoc IDP Lead validates the project to ensure the data integrity standards are met using the Validation Checklist and creates a Validation Report.

  2. IDP Review and Amendments: Indoc IDP Lead sends the Validation Report to the NI Lead or Designer who reviews the project to correct warnings, apply applicable suggestions, and do any additional testing.

  3. Amendment Validation: Steps 1-2 are repeated until all standards are met, whereby the IDP Lead will approve the project status change to production.

  4. Push to Production: Once in production, coordinators or data entry persons can be granted access to the project and participant data can be entered. The Study MDR will be updated to mark the project as validated and federate any data to the Brain-CODE Federation System.

Project Amendment Validation

  1. REDCap Project Amendment: If the need arises for amendments to the project, the NI Lead can put the project into Draft mode and which will make changes without affecting the integrity of the database.

  2. Amendments Submitted for Validation: When changes are complete, the IDP PM or Designer submits the amendments for review.

  3. Amendment Validation: Indoc IDP Lead validates the project changes to ensure the data integrity standards are met and creates an Amendment Report which is sent to the NI Lead for review.

    1. Note - This step may involve the creation of a Test Version of the REDCap project where the changes are applied and tested outside of the production environment.

  4. IDP Review and Amendments: The NI Lead reviews the Amendment Report corrects any issues, applies applicable suggestions, and performs any necessary testing in the Test Version of the REDCap project.

  5. Amendment Validation: Steps 1-3 are repeated until all standards are met, whereby the IDP Lead will approve the project amendments and push them to production.

  6. Push to Production: Once in production, the project amendments will be visible to participants and researchers in the production project.

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