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This articles describes the steps required for Creation the creation and Validation validation of a new REDCap Project project on the Brain-CODE Instance of REDCap. REDCap projects can be designed and amended by a Designated Project Designer who has completed the Advanced REDCap Training module. Please note that REDCap project creation, validation, and any changes to the Project Status in REDCap must be completed by an Indoc IDP Lead.

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 The by copying a template Brain-CODE project which contains all Common Data Elements (CDEs).

   2. The Indoc IDP lead ensures the Subject Enrolment and Informed Consent Form is imported into the new project Any Brain-CODE Common Data Elements (CDEsform and all of the CDE electronic Case Report Forms (eCRFs) that will be collected by the study are imported into the new projectincluded in the project and up-to-date.

   3. The Indoc IDP Lead grants access to the project to the Designated Project Designer.

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 or imported by the IDP Neuroinformatics LeadDesignated Project Designer.

   2. Study arms, events, event designations, and other customizations are configured by the NI Lead Designated Project Designer 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. to match the study protocol.

   7. The Designated Project Designer tests all forms and features of the REDCap project to ensure they adhere to the study protocol and are working as expected. Additional users can be added to test the project, provided no real participant data is entered, while the project is still in development

4. REDCap Project Submitted for Review:

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

   2. The Study ProtocolDesignated Project Designer sends the study protocol, original Case Report Forms (CRFs) and all relevant Informed Consent Forms are sent to OBI and Indoc for reviewthe Indoc IDP Lead and OBI Data Quality Team.

Project Validation (6-8 weeks)

1. Creation Validation:

   1. Indoc IDP Lead validates the project to ensure

   the data integrity standards

   1. case report form best practises are met using the Validation Checklist and creates a Validation Report which lists all flagged issues and suggested fixes.

   IDP Review and Amendments:

   1. Indoc IDP Lead sends the Validation Report to the

   NI Lead who reviews

   1. Designated Project Designer.

2. IDP Review and Amendments:

   1. The Designated Project Designer reviews the Validation Report, updates the project to correct

   warnings, apply applicable suggestions, and perform any additional testing

   1. any issues flagged during validation, and documents the rationale for any rejected suggestions.

   2. The Designated Project Designer thoroughly tests any changes made to the project.

   3. The Designated Project Designer sends the Validation Report back to the Indoc IDP Lead with details on changes and/or rationale for each flagged issue.

3. Amendment Validation:

   1. Steps 1-2 are repeated until the Indoc IDP Lead has confirmed that all standards

   are met, at which point

   1. have been met.

   2. Once validation is complete, the Indoc IDP Lead

   will approve the project status change to production

   1. updates the Brain-CODE Study MDR to mark the project as validated.

4. Push to Production: Once in production,

   1. The Indoc IDP Lead updates the study status in Brain-CODE Study MDR and enables federation of the data to the Brain-CODE Federation System.

   2. The Indoc IDP Lead deletes all test records from the project.

   3. Once in Production, participant data is permitted to be entered and 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:

   1. .

Project Amendment Validation

Any changes that need to be made to a project that is in Production must be reviewed and approved by an Indoc IDP Lead.

...

...

1. REDCap Project Amendment:

   1. For minor amendments, the Designated Project Designer puts the project into Draft mode in the online designer and makes their changes to the project.

   2. For major amendments, the Designated Project Designer requests a copy of the REDCap project that does not contain participant data, from the Indoc IDP Lead, and implements their changes in the test project.

2. Amendments Submitted for Validation: When changes are complete and have been thoroughly tested, the NI Lead submits Designated Project Designer can submit the amendments for review by emailing the following information to the Indoc IDP Lead:

   1. The Project ID of the project that requires validation.

   2. A list of the changes made to the project and their rationale.

   3. Documentation of REB Approval for any changes that would affect the Study Protocol.

   4. Original versions of any new eCRFs to be added.

3. Amendment Validation:

   1. The Indoc IDP Lead validates the project changes to ensure

   the data integrity standards

   1. case report form best practises are met and

   creates

   1. amendments will not cause any existing data to be altered, orphaned, or lost.

   2. The Indoc IDP Lead sends an Amendment Report

   which is sent

   1. 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.

   1. Designated Project Designer.

4. IDP Review and Amendments:

   1. The

   NI Lead

   1. Designated Project Designer reviews the Amendment Report,

   corrects

   1. updates the project to correct any issues

   , applies applicable suggestions, and performs any necessary testing in the Test Version of the REDCap project

   1. flagged, and documents the rationale for any rejected suggestions.

   2. The Designated Project Designer thoroughly tests any changes they made to the project.

   3. The Designated Project Designer sends the Amendment Report back to the Indoc IDP Lead with details on changes/rationale for flagged issues.

5. Amendment Validation:

   1. Steps 1-

   3

   1. 2 are repeated until the Indoc IDP Lead has confirmed that all standards

   are met, at which point the IDP Lead will approve the project amendments and push them to production

   1. have been met.

6. Push to Production: Once in production

   1. The Indoc IDP Lead approves the changes in REDCap. Once approved, the project amendments will be visible to

   participants and researchers

   1. data entry users and on survey pages sent to participants in the production project.

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