Skip to end of metadata
Go to start of metadata

You are viewing an old version of this content. View the current version.

Compare with Current View Version History

« Previous Version 2 Next »

Reference eCRF Creation Validation Training:

Project Initiation

  1. Project Creation Process

  2. Initiation: OBI approves the initiation of a study.

  3. Creation: Indoc IDP Lead creates the study project on REDCap.

  4. Import: Standard forms for Participant Informed Consent, CDEs, etc. are imported by an IDP PM or IDP user with Designer permissions.

  5. Design: Additional electronic Case Report Forms (eCRFs) are created, modified, and tested thoroughly by the IDP.

  6. IDP Request: A request to have the project moved to production is submitted by the IDP PM or Designer.

Project Validation

  1. Validation: Indoc IDP Lead validates the project to ensure the data integrity standards are met using the Validation Checklist (Appendix Section 3) and creates a Validation Report.

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

  3. Approval: Steps 6-7 are repeated until all standards are met, whereby the IDP Lead will approve the project status change to production.

  4. Production: Once in production, coordinators or data entry persons can be granted access to the project and participant data can be entered.

  5. Design 2: If the need arises for amendments to the project, the IDP PM or Designer can put the project into Draft mode and can make changes without affecting the integrity of the database.

  6. IDP Request 2: When changes are complete, the IDP PM or Designer requests that the changes be moved into production.

  7. Validation 2: Indoc IDP Lead validates the project changes to ensure the data integrity standards are met and creates an Amendment Report. This step may involve the creation of a Test Version of the REDCap project where the changes are applied and testing outside of the production environment.

  8. IDP Review 2: Indoc IDP Lead sends the Amendment Report to the IDP PM or Designer who reviews the project to correct warnings, apply applicable suggestions, and do any additional testing in the Test Version of the REDCap project.

  9. Approval 2: Steps 12-13 are repeated until all standards are met, whereby the IDP Lead will approve the project changes.

  10. Steps 10-14 are repeated whenever any modifications need to be made to the REDCap project.

Push to Production

  • No labels