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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. New Please note that REDCap project creation, validation, and any changes to the Project Status in REDCap must be completed by an Indoc IDP Lead.

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

   2. The Indoc IDP lead ensures the Subject Enrolment and Informed Consent form and all of the most up-to-date CDEs CDE electronic Case Report Forms (eCRFs) that will be collected by the study are included 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 manually created or imported by the Designated Project Designer.

   2. Study arms, events, event designations, and other customizations are configured by the Designated Project Designer in the Project Settings page to match the Study Protocolstudy protocol.

   3. The Designated Project Designer tests all forms and features of the REDCap project , ensuring to ensure they adhere to the Study Protocol 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 Designated Project Designer.

   2. The Designated Project Designer sends the Study Protocolstudy protocol, original Case Report Forms (CRFs) and all relevant Informed Consent Forms to the Indoc IDP Lead and includes the OBI Data Quality teamTeam.

Project Validation (6-8 weeks)

1. Creation Validation:

   1. Indoc IDP Lead validates the project to ensure the case report form best practises are met using the Validation Checklist and creates a Validation Report which lists all flagged issues and suggested fixes.

   2. Indoc IDP Lead sends the Validation Report to the Designated Project Designer.

2. IDP Review and Amendments:

   1. The Designated Project Designer reviews the Validation Report, updates the project to correct any issues flagged during validation, 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 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 have been met.

   2. Once validation is complete, the Indoc IDP Lead updates the Brain-CODE Study MDR to mark the project as validated. and sends the project metadata XML file to the OBI Data Quality Team.

4. Data Quality Framework Implementation:

   1. The OBI Data Quality Team generates the Participant Status Form (PSF) and Missing Data Flagging Form (MDFF) using the project metadata XML file and sends to the Designated Project Designer.

   2. The Designated Project Designer imports the PSF and MDFF into their REDCap project and tests to ensure both forms are working as expected.

5. Push to Production:

   1. The Indoc IDP Lead confirms that the PSF and MDFF have been added to the REDCap project and updates the project status in REDCap to Production.

   2. The Indoc IDP Lead updates the study status in Brain-CODE Study MDR to mark the project as in Production and ready to federate and enables federation of the data to the Brain-CODE Federation System.

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

   4. Once in production, Production, participant data is permitted to be entered and access to the project can be requested for coordinators or data entry persons by an approved requester and participant data is permitted to be entered.

Project Amendment Validation

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

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1. REDCap Project Amendment:

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

   2. If complex changes are planned 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 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 case report form best practises are met and amendments will not cause any existing data to be altered, orphaned, or lost.

   2. The Indoc IDP Lead sends an Amendment Report to the Designated Project Designer.

4. IDP Review and Amendments:

   1. The Designated Project Designer reviews the Amendment Report, updates the project to correct any issues 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 1-2 are repeated until the Indoc IDP Lead has confirmed that all standards have been met.

   2. If eCRFs were added, removed, or renamed, or if any changes were made to the Study Event Schedule, the Indoc IDP Lead will send the project metadata XML file to the OBI Data Quality Team.

6. Data Quality Framework Implementation:

   1. The OBI Data Quality Team generates updated versions of the Participant Status Form (PSF) and Missing Data Flagging Form (MDFF) using the project metadata XML file and sends to the Designated Project Designer.

   2. The Designated Project Designer imports the PSF and MDFF into their REDCap project and tests to ensure both forms are working as expected.

7. Push to Production:

   1. The Indoc IDP Lead confirms that the PSF and MDFF have been updated (if required) and validates to ensure they are working as expected.

   2. The Indoc IDP Lead approves the changes in REDCap. Once approved, once approved the project amendments will be visible to data entry users and on survey pages sent to participants in the production project.

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