ApprovalReview
Provides information about the Approval Review undertaken in relation to the activity. Identifies the organization processing the review, the role of the approval review organization, case number, description, and related dates. Allows the inclusion of a reference to an external source detailing the approval review.
Properties
Name |
Type |
Description |
|
|---|---|---|---|
TypeOfApprovalReview |
0..n |
A brief identification of the type of approval review such as IRB, ethical, compliance, etc. Supports the use of a controlled vocabulary. |
|
ReviewObjectReference |
0..n |
Reference to an existing identifiable object using the Reference structure. TypeOfObject should be set to any Versionable or Maintainable object. |
|
AgencyOrganizationReference |
0..n |
Reference to an organization or individual, that provided the approval review. TypeOfObject should be set to Organization. |
|
ReviewerRole |
0..1 |
Role of the reviewing organization or individual. Supports the use of a controlled vocabulary. |
|
ReferenceIdentifier |
0..n |
The reference or case identification of the review. Used to specify or track the case by the review organization |
|
Description |
0..1 |
Description of the approval review which can include requirements for the review, contents, or results. |
|
ApprovalReviewDocumentReference |
0..1 |
Link to a document related to the ethical review using the OtherMaterial structure. |
|
ApplicationDate |
0..1 |
Date materials submitted for approval review. |
|
ApprovalDate |
0..1 |
Date approval received from approval review organization. |
|
ApprovedPeriod |
0..1 |
Period for which the approval is valid. This may be a start date, and end date, or range specified as a start and end date. |
Properties Inherited from Versionable
Name |
Type |
Description |
|
|---|---|---|---|
URN |
1..1 |
||
Agency |
1..1 |
||
ID |
1..1 |
||
Version |
1..1 |
||
UserID |
0..n |
Allows for the specification of identifiers other than the specified DDI identification of the object. This may be a legacy ID from DDI-C, a system specific ID such as for a database or registry, or a non-DDI unique identifier. As the identifier is specific to a system the system must be identified with the UserID structure. |
|
UserAttributePair |
0..n |
A system specific user defined property of the object expressed as a key/value pair. As this is specific to an individual system the use of controlled vocabularies for the key is strongly recommended. |
|
VersionResponsibility |
0..1 |
Person or organization within the MaintenanceAgency responsible for the version change. If it is important to retain the affiliation between and individual responsible for the version and his/her agency, it may be included in this notation. This is primarily intended for internal use. |
|
VersionResponsibilityReference |
0..1 |
Reference person or organization within the MaintenanceAgency responsible for the version change, as described in an OrganizationScheme. If it is important to retain the affiliation between and individual responsible for the version and his/her agency, a Relation should be created between the individual referenced here and his/her organization. This is primarily intended for internal use. |
|
VersionRationale |
0..1 |
Textual description of the rationale/purpose for the version change and a coded value to provide an internal processing flag within and organization or system. Note that versioning can only take place on objects owned by the specified DDI Agency. If you are creating a local instance of an object from another agency for current or future modification use BasedOnObject. If the changes being made result in what you determine to be new object rather than a version of a previous object, i.e. the change is too extensive to consider it a version of the existing object, create a new object and use BasedOnObject to provide a link to the object or objects that were a basis for the new object. |
|
BasedOnObject |
0..1 |
Use when creating an object that is based on an existing object or objects that are managed by a different agency or when the new object is NOT simply a version change but you wish to maintain a reference to the object that served as a basis for the new object. BasedOnObject may contain references to any number of objects which serve as a basis for this object, a BasedOnRationalDescription of how the content of the referenced object was incorporated or altered, and a BasedOnRationalCode to allow for specific typing of the BasedOnReference according to an external controlled vocabulary. |
|
RelatedOtherMaterialReference |
0..n |
The inclusion of an existing OtherMaterial by reference. Use for any type of OtherMaterial not specifically addressed by an inline description for such as ExternalAid in QuestionItem. |
|
VersionDate |
0..1 |
Date of version using the union set BaseDateType. Duration should not be used in this field, even though allowed by the ISO format enforced by the parser. |
|
IsPublished |
0..1 |
Indicates that the maintainable will not be changed without versioning, and is a stable target for referencing. |
Item Type Hierarchy
- Versionable
ApprovalReview
Relationships
The following identified item types reference this type.
Item Type |
Property |
|---|---|
ReviewObjectReference |
|
LifecycleInformation/LifecycleEvent/Relationship/RelatedToReference_Versionable |
|
ItemMap/SourceItemReference |
|
ApprovalReviewReference |
|
LocalAddedContent/ContentLinkingMap/LinkingMap/LocalObjectReference_Versionable |
|
Note/Relationship/RelatedToReference_Versionable |
|
Relationship/RelatedToReference_Versionable |
|
ApprovalReviewReference |
|
ApprovalReviewReference |
|
BasedOnObject/BasedOnReference |
