Advantages

Although this definitional approach initially requires more work, it has the following advantages:

• Regulatory Compliance. Oracle LSH helps your company comply with industry regulations by maintaining version control over all definitional objects, and enabling you to set and meet criteria for validating all objects (see Validating Object Definitions and Instances).

  Note:

  You can recreate submitted (or other) data by running the same version of the program(s) that you originally used to generate the submitted data on the data that was current at that time, using a labeled or timestamp-based data snapshot.
• Reuse. You can reuse object definitions, reducing work and increasing consistency. You can create new instances of existing object definitions or you can copy object definitions and modify them as necessary (see Reusing Object Definitions).
• Security. You can develop a security system to control access to, and operations on, objects and outputs,which are stored as objects (see Designing a Security System).
• Classification. You can develop a classification system and classify objects and outputs accordingly. Classification allows you to label the many objects and outputs created in the course of a clinical trial to make them easier to find through searching and browsing (see Designing a Classification System for Searching and Browsing).

  The following sections describe each data handling stage and the object type(s) predefined for use in each stage. Further information on object definition is included in Designing an Organizational Structure and in "Applications User Interface" in the Oracle Life Sciences Data Hub Application Developer's Guide.