Assignments to Specific Objects

Individual objects are classified as follows:

• Project. The Project 123 and Project 456 Domains are each assigned to the Project level with a value of Project 123 and Project 456 respectively. They do not have values assigned for the Study or Site level. The Companywide Reports and Company Standard Definitions Domains do not have any values assigned for any levels in the Project > Study > Site hierarchy, and neither do any of the objects they contain.

  Note:

  These Domains contain only definitions and definitions are not displayed in the Reports window, and they are not specific to any particular project, study, site, or patient so it is not necessary to classify this Domain to the Project > Study > Site > Patient hierarchy. These classifications would not be useful in either searching or browsing. However, Program, Report Set, and Workflow definitions within the Domain must be classified to a Group in the Division > Department > Group hierarchy; see Division > Department > Group.

  The project-level Application Areas are assigned to the Project level with a value of Inherited so that they are automatically classified to the same project as their Domain.

  The Work Areas within the project-level Application Areas are also assigned to the Project level with a value of Inherited so that they are automatically classified to the same project as their Application Area.

  All the object definitions in the project-level Application Area and in the Domain library, and all the object instances in their Work Areas, are also assigned to the Project level with a value of Inherited so that they are automatically classified to the same project as their container.

• Study. The study-level Application Areas are each assigned to the Study level with the value corresponding to their study: Study 123ABC, Study 123DEF, Study 456MNO, and Study 456PQR. The Project value they originally inherited has been explicitly removed.

  Each Work Area within each study-level Application Area is assigned to the Study level with a value of Inherited so that they are automatically classified to the same study as their Application Area.

  Most object definitions contained in the study-level Application Areas and object instances contained in their Work Areas are also assigned to the Study level with a value of Inherited so that they are automatically classified to the same study as their Application Area.

• Site. Some object definitions and instances within a study-level Application Area or Work Areas generate or contain information that is specific to a site rather than to the whole study. Those particular objects are classified to the Site level, with the value of the particular site or sites whose data they contain, transform, or report. The study-level classification value they inherited has been explicitly removed.
• Patient. Some object definitions and instances within the study-level Application Areas or Work Areas generate or contain information that is specific to a particular patient; for example, a serious adverse event report. Those objects are classified to the Patient level. When the Definer creates Program to generate a report on information about a single patient, the Definer does not know in advance which patient will require the report. Therefore the Definer must make the Patient ID an input/output Parameter of the report. The Definer can also use this Parameter to classify the report to the appropriate Patient ID.