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The following table explains the accepted definition and use of = workflow statuses for data elements and other administered items.
Status |
Definition |
---|---|
Draft New |
Status assigned to new Administered Items cre= ated during protocol review or in response to another request. Changes do n= ot require versioning of items. |
Draft Mod |
Status assigned to new versions of existing A= dministered Items created to accommodate and represent requested changes.= p> |
Released |
Status assigned to new or modified Data Eleme= nts, and their associated Administered Items, that have been reviewed and a= pproved by the owning Context's review process (by committee or other decis= ion-maker). Released Administered Items must be fully specified and complia= nt with the ISO 11179 model and associated naming guidelines and convention= s. Changes to Released items require adherence to versioning rules.= p> |
Retired Archived |
Status assigned to old versions of Administer= ed Items that have been replaced with new versions. Retired Archived Data E= lements should not be used on future trials and should not be sent through = the owning Context's review process again. |
Released-non-compliant |
Temporary status assigned to Released Data El= ements that are not fully specified or compliant with the ISO 11179 standar= ds and guidelines; these Data Elements will be specified and assigned the R= eleased workflow status. |