The accepted definition and use of workflow statuses for data elements and other administered items are explained below.
Status | Definition |
|---|---|
Draft New | Status assigned to new Administered Items created during protocol review or in response to another request. Changes do not require versioning of items. |
Draft Mod | Status assigned to new versions of existing Administered Items created to accommodate and represent requested changes. |
Approved for Trial Use | Status assigned to Draft New Data Elements included on CDE-compliant forms, as well as their associated Administered Items. Promotion to this status occurs when the Administered Component has been fully specified and CRFs with which the Data Element is associated are deemed CDE-compliant. |
Committee Submitted | Status assigned to new or modified Data Elements, and their associated Administered Items, created and submitted for review by a CDE Disease Committee. |
Committee Submitted Used | Status assigned to new or modified Data Elements, and their associated Administered Items, that have been approved for use on a trial and submitted to a CDE Disease Committee for review. Committee Submitted Used Administered Items must be fully specified. |
Committee Approved | Status assigned to Committee Submitted or Committee Submitted Used Data Elements, and their associated Administered Items that have been approved for general use by a CDE Disease Committee. Promotion to this status occurs upon consensus of the validity of the Data Element by the Committee. |
Released | Status assigned to new or modified Data Elements, and their associated Administered Items, that have been reviewed and approved by the owning Context's review process (by committee or other decision-maker). Released Administered Items must be fully specified and compliant with the ISO 11179 model and associated naming guidelines and conventions. Changes to Released items require adherence to versioning rules. |
Retired Withdrawn | Status assigned to Data Elements, and their associated Administered Items, that have not been subjected to the owning Context's review process (by committee or other decision-maker), including those created for grandfathered protocols (those approved prior to the creation of Released Data Elements for the disease under study). This also includes Draft New or Draft Mod Data Elements, and their associated Administered Items that are removed from submitted CRFs prior to the forms being deemed CDE-compliant and Data Elements, and their associated Administered Items that are removed from consideration prior to the owning Context's review process. Retirement may only occur if the Data Element is not being used on other CRFs. Retired Withdrawn Data Elements may be used on future CRFs as Draft New. |
Retired Phased Out | Status assigned to new Data Elements or modified versions (not old versions) of Data Elements, and their associated Administered Items, that have been rejected for general release during the owning Context's review process (by committee or other decision-maker). Retired Phased Out Data Elements should not be sent through another round of the owning Context's review process, but may be used as a last-resort on future protocols, if the need is determined by the CRF reviewer. |
Retired Archived | Status assigned to old versions of Administered Items that have been replaced with new versions. Retired Archived Data Elements should not be used on future trials and should not be sent through the owning Context's review process again. |
Retired Deleted | Status assigned to Administered Items that were created in error and may be deleted from the database. Retired Deleted Data Elements should not be viewed in the CDE Browser and should not be used on CRFs. |
Released-non-compliant | Temporary status assigned to Released Data Elements that are not fully specified or compliant with the ISO 11179 standards and guidelines; these Data Elements will be specified and assigned the Released workflow status. |
