Example of an Oracle Clinical Distributed Study

Figure 13-1 illustrates a sample installation configuration for an Oracle Clinical study that is distributed over three physically separate locations.

In this installation:

• One study is being conducted at the investigation sites, that is, Hospital A, Hospital B, Hospital C, and Hospital CA.

• Location A is the Global Library-owning location.

• Location C is the study-owning location.

• Location A and Location B are study-sharing locations.

For more information , see:

• Location A Maintains Global Information
  
• Location C Replicates the Global Library
  
• Sharing Locations Replicate Study Design and Definitions
  
• Local Processing and Lab Replication
  

Location A Maintains Global Information

As the Global Library-owning location, Location A is responsible for maintaining Global Library objects, and global lab information (lab units and panels).

Location C Replicates the Global Library

Location C, which is the study-owning location, is responsible for designing the study and defining study elements. Before beginning the study design and definitions, Location C must replicate the Global Library from Location A. To complete the study definition, Location C may need the global lab information as well. The heavy black arrow between Location C and Location A represents this replication task.

Sharing Locations Replicate Study Design and Definitions

Once Location C completes the study design and definitions, and makes the study available for replication, then the other locations (Location A and Location B) must replicate these study elements from Location C. The heavy gray arrows from Location C to both Location A and Location B represent this replication task.

Location A and Location B cannot modify any of the study design or definition elements. However, these locations must maintain certain local responsibilities such as assigning sites and investigators.

Local Processing and Lab Replication

Each location in the installation deals with local facilities to conduct their part of the study.

Location A conducts investigations at Hospital A and processes results at Lab A. Likewise, Location B conducts investigations at Hospital B and processes results at Lab B. Each of these Oracle Clinical locations is a lab-owning location for its local lab.

Location C has two hospitals serving as investigation sites, but this setup has no ramifications for replication. However, the lab setup at Location C does have an effect on replication. Location C is the lab owner for Lab Central, which services Location C and also processes some tests for the other locations. As part of its lab owning responsibility, Location C maintains the lab ranges for Lab Central. Because the other locations (Location A and Location B) use Lab Central, they must replicate the ranges for Lab Central from Location C. The dotted-line arrows from Location C to both Location A and Location B represent this replication task.

Figure 13-1 Sample Installation with Three Physically Separate Locations

Description of "Figure 13-1 Sample Installation with Three Physically Separate Locations"

The following table summarizes the roles and responsibilities for each location (Location A, Location B, and Location C) in the sample Oracle Clinical distributed study.

Table 13-1 Roles and Responsibiliities for Locations of Distributed Studies

Location	Roles	Responsibilities
Location A	Global Library Owner	Maintain Global Library objects Maintain global lab informatin--lab units and panels Maintain textbook ranges
Location A	Lab Owner (Lab A)	Maintain lab units Maintain ranges for this lab
Location A	Study-sharing location	Replicate study design Replicate study definition (initial) Replication study definition (periodic)
Location A	Lab user (Central Lab)	Replicate lab range information
Location B	Non-Global Library owner	Replicate Global Library (initial) Replicate Global lab data (initial) Replicate Global Library (periodic) Replicate Global lab data (periodic)
Location B	Lab owner (Lab B)	Maintain lab units Maintain ranges for this lab
Location B	Study-sharing location	Same as Location A
Location B	Lab user (Central Lab)	Same as Location A
Location C	Non-Global Library owner	Same as Location B
Location C	Lab owner (Central Lab)	Maintain lab units Maintain ranges for this lab
Location C	Study-owning location	Replicate Global Library (initial) Replicate Global Library (periodic)