Notice: This application will enforce Multi-factor authentication (MFA) for NIH users beginning the evening of Wed Aug 3rd.
NIH | National Cancer Institute | NCI Wiki  

Status and Definitions

1. The accepted definition and use of Workflow Statuses for Data Elements and other Administered Items are explained below. Additional information about rules associated with Workflow Statuses is also available.(Updated 14 July 2003).

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Retired Withdrawn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.

2. The accepted definition and use of Registration Statuses for Data Elements and other Administered Items are explained below. A document outlining Registration Statuses is available  

Status

Definition

Standard

The Administered Component has all necessary metadata, has met all quality requirements, and has been approved for usage in all contexts.

Candidate

The Administered Component has all the necessary metadata, has met all quality requirements, and has been proposed for usage in all contexts.

Proposed

The Administered Component has met all quality requirements, and is ready to be proposed for usage in all contexts.

Qualified

The Administered Component has met all quality requirements, and is ready to be reviewed for usage in all contexts.

Retired

The Administered Component is no longer recommended for use as a NCI standard.

Superseded

The Administered Component is no longer recommended for use in the NCI community because it has been replaced by another preferred Administered Component.

Standardized Elsewhere

The Administered Component has been adopted for standard usage by a community outside of NCI.

Application

The Administered Component is part of a computer program or application and may not have all the metadata generally required by the registry.

Suspended

The Administered Component has been considered for standard status in the past and was not selected for promotion.

3. The Registration Status of Qualified, Candidate, and Standard will be assigned to Administered Items that are considered for usage across all NCI contexts. These three dynamic Registration Statuses address progression toward acceptance for general usage. The relationships with Workflow Statuses are explained below. (20 April 2005) A document outlining the relationship between Registration and Workflow Statuses is available

Registration Status

Workflow Status

Definition

Standard

Released

An Administered Component in the "Standard" status indicates that the Context Administrators confirm that the Administered Component is of sufficient quality and of broad interest for use in all contexts. There may be more than one "Standard" Administered Component that addresses the same function, concept, etc.

Candidate

Released

An Administered Component in the "Candidate" status shall indicate that it has been proposed for standardization review by the Context Administrators. To be considered a "Candidate" an Administered Component must be promoted to a Workflow Status of "Released".

Proposed

Released

An Administered Component has met all quality requirements, and is ready to be proposed for usage in all contexts. To be considered a "Proposed" an Administered Component must be promoted to a Workflow Status of "Released".

Qualified

Released
Committee Approved
Committee Submitted
Approved for Trial Use

An Administered Component has met all quality requirements, and is ready to be reviewed for usage in all contexts. The Context Administrators have confirmed that the mandatory metadata attributes are complete and conform to applicable quality requirements. An Administered Component can be assigned a "Qualified" Registration Status when it reaches one of the Workflow Statuses listed. It will be reviewed to determine if it represents an information concept of interest across contexts. If the context administrators determine the Administered Component should become a candidate for standardization, it can be promoted to a Registration Status of "Proposed." If the Context Administrators determine that the Administered Component is not a candidate for standardization, a Registration Status of "Suspended" will be assigned.

4. The following Registration Statuses will be assigned to Administered Items that have reached a stage where they are no longer being recommended for usage across contexts (Retired, Superseded, and Suspended) or have been recorded in the registry from another source (Standardized Elsewhere, Application.) These Registration Statuses are considered to be static with additional changes not anticipated once they have been assigned. The relationships with Workflow Statuses are explained below. (20 April 2005) A document outlining the relationship between Registration and Workflow Statuses is available.

Registration Status

Workflow Statuses

Notes

Superceded

Released
Retired Archived

An Administered Component in the "Superseded" status indicates that the Context Administrators have decided that the Administered Component is no longer recommended for use in the registry community. A "Superseded" Administered Component may be used but the successor-Administered Component is the preference for use. Such Administered Items are retained in the Registry for historic reference purposes.

Standardized Elsewhere

Released

A Standardized Elsewhere Administered Component carries its identification and meta-attributes from its originating registry, if available.

Retired

Released
Retired Withdrawn
Retired Phased Out
Retired Archived

A Retired Administered Component should not be used in new applications or studies but may continue to be used in applications or studies that were using the Administered Component before it was Retired. Retired Administered Items are retained in the Registry for historic reference purposes.

Application

Released-non-compliant

Administered Items with the "Application" status may be from application systems and not have fully attributed registry metadata.

Suspended

Released
Committee Approved
Committee Submitted
Approved for Trial Use

The Administered Component has been considered for standard status in the past and was not selected for promotion. This status will record historical decisions on a candidate standard.

 

5. Multiple versions of a Data Element should not exist with the same Workflow Status. (Determined 12 May 2003)

6. 'Released' Data Elements must be compliant with the ISO 11179 model and the naming conventions or the owning Context (to be discussed/determined) and have their attributes fully specified. (Determined 12 May 2003)

7. 'Released' Data Elements may not undergo any changes except those allowed in the released versioning rules. (Updated 14 July 2003)

8. 'Draft Mod' Data Elements are created to represent modifications to an existing Data Element that is in use or has been released. The in use/'Released' version is maintained and a new version is created and assigned the 'Draft Mod' status. The new and old versions will be considered side-by-side and result in one version being rejected and retired and the other version being approved and released. Should it be determined that both Data Elements are useful and distinct, the old version should be assigned a status of 'Released'; the new version should be retired and then copied and released to create a distinct Data Element. (Determined 12 May 2003)

9. The accepted rules for versioning Data Elements, Value Domains, and Data Element Concepts are explained in the Metadata Versioning Rules section. General rules are below. These rules can not be fully implemented until the release of caCORE 2.0 (functionality to specify whether version increment is "whole number" or "partial" anticipated in October 2003), but Contexts will immediately follow guidelines for when it is/is not necessary to create a new version. (Determined 30 June 2003)

a) The initial Version number assigned to all Administered Items is to be 1.0.
b) When a "whole number" version increment is required, the next Version number will be the next whole number (e.g., 2.3, 3.0).
c) Following nine "partial" version increments (i.e., by one-tenth), the next Version number will be the next whole number (e.g., 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0).

10. Users should not be able to view, select, or search for Data Elements with a workflow status of 'Retired Deleted' through the CDE Browser or CCRR. (Determined 12 May 2003)

11. Although preference shall be given to 'Released' Data Elements, a compliance reviewer may select Data Elements of any workflow status, including those that have been retired, to be used on CRFs for grandfathered protocols. Once Data Elements have been associated with a protocol/CRF, their workflow status may be changed without affecting their use for the protocol. (Determined 12 May 2003)

12. The accepted rules for Designations (designating a Data Element owned by another Context for use in yours) are explained in the Designations section. These rules can not be fully implemented until the release of caCORE 2.0 (functionality to designate non-Released Data Elements anticipated in October 2003), but Contexts will immediately use these rules to designate Released Data Elements. (Determined 28 July 2003)

  • No labels