(TBD: For each status, which description is most accurate? Legacy description, description in GUI, or comment in GUI?)
The following table explains the accepted definition and use of workflow statuses for data elements and other administered items.
Status | Definition |
|---|---|
Draft New | Legacy Description: Status assigned to new Administered Items created during protocol review or in response to another request. Changes do not require versioning of items. Description in GUI: Status assigned to a new Administered Item that is under development or pending review by the owning SO/Context. Comment in GUI: Status assigned to new Administered Component created during protocol review or in response to another request. |
Draft Mod | Legacy Description: Status assigned to new versions of existing Administered Items created to accommodate and represent requested changes. Description in GUI: Status assigned to a new version of an existing Administered Item while it is under review and pending approval by the owning SO/Context. Comment in GUI: Status assigned to new versions of existing Administered Components created to accommodate and represent requested changes. |
Released | Legacy Description: 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. Description in GUI: Status assigned to a new or modified Administered Item that has been reviewed and approved by the owning SO/Context. Comment in GUI: Status assigned to new or modified Data Elements, and their associated Administered Components, that have been reviewed and approved by the owning context's review process (by committee or other decision-maker). Released Administerd Components must be fully specified and compliant with the ISO 11179 model and associated naming guidelines and conventions. |
Retired Archived | Legacy Description: 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. Description in GUI: Status assigned to old or replaced versions of an Administered Item or Administered Items created for grandfathered protocols. Comment in GUI: Status assigned to old versions of Administered Components 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. |
Released-non-compliant | Legacy Description: 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. Description in GUI: Status for short-term use only, to be replaced long term Comment in GUI: Status not to be used long-term, but is needed temporarily; contexts that have EXISTING Released elements that are not compliant may direct NCICB to change their status to Released-non-compliant or to Approved for Trial Use. Otherwise, no new elements should be assigned to this status. 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 designated as Released. |
