REDCap Project Creation and Validation

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

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 new project

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

3. REDCap Project Design:

   1. Additional electronic Case Report Forms (eCRFs) that will be collected as part of the study are imported or manually created by the IDP Neuroinformatics Lead

   2. Study arms, events, event designations, and other customizations are configured by the NI Lead in the Project Settings page.

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

   4. The NI Lead sends the REDCap project XML to the OBI Data Quality Team

   5. OBI generates the Participant Status Form (PSF) and Missing Data Flagging Form (MDFF) based on the project XML and sends them to the NI Lead

   6. The NI Lead imports the PSF and MDFF into the REDCap project and designates them to appear at the appropriate event.

   7. The NI Lead tests all forms and features of the REDCap project, ensuring they adhere to the Study Protocol and are working as expected.

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 who reviews the project to correct warnings, apply applicable suggestions, and perform any additional testing.

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

4. Push to Production: Once in production, access to the project can be requested for coordinators or data entry persons and participant data is permitted to be entered. The Study MDR will be updated to mark the project as validated and to 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 make changes without affecting the integrity of the database.

2. Amendments Submitted for Validation: When changes are complete, the NI Lead submits the amendments for review.

3. Amendment Validation: The 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, at which point 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.