Content Comparison

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1. Creation Validation:

   1. Indoc IDP Lead validates the project to ensure 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 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.

   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.

4. 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. 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.

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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 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.

   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.

6. 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. The Indoc IDP Lead approves the changes in REDCap. 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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