Integration Entitles for Siebel Clinical and Oracle Clinical

Table 16-2 lists the entities for the areas of the Siebel Clinical and Oracle Clinical applications that the integration supports, and describes the entity mapping between Siebel Clinical and Oracle Clinical.

Table 16-2 Integration Entitles for Siebel Clinical and Oracle Clinical

Siebel Clinical Entity	Oracle Clinical Entity	Description
Protocol	Study	A document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. In Siebel Clinical, protocol is synonymous with study.
Protocol site	Study site	A protocol site, or study site, is the site at which an investigator carries out a clinical trial. It is used for planning, budgeting, and payments related to a clinical trial. In Siebel Clinical, you create sites at the protocol level to associate accounts (locations) with investigators (physicians). Oracle Clinical uses study sites at a protocol level to associate sites (locations) with investigators (physicians).
Account address	Site	The organization that is associated with the investigator on the study. This entity is not associated with a study. An account is not equivalent to a site in Oracle Clinical. In Siebel Clinical, the account includes all the locations of an organization. In Oracle Clinical, a site is a particular location where a clinical study can be conducted. In Oracle Clinical, the same site cannot be included in the study with different principal investigators. In Siebel Clinical, an account can belong to multiple protocol sites in a protocol with a different principal investigator assigned to each one. The account and primary address for the protocol site is used to create a site in Oracle Clinical.
Principal investigator (PI)	Investigator	The physician or clinician responsible for conducting the trial.
Not applicable	Patient position	In Oracle Clinical, an identifier or a placeholder for a participant in a clinical study. Patient positions are created using the target enrollment in a study and assigned to a study site. As each subject is enrolled, or data is collected for that subject, the subject is assigned to a patient position.
Subject	Patient	Persons that investigators recruit. Patients participate in a clinical trial at a study site.
Subject visit template	Data Collection Instrument (DCI) Book	The expected events that you conduct during the clinical trial, as specified in the study protocol. Expected events include visits and activities or procedures.
Subject visit schedule	Not applicable	The planned schedule of events for a particular subject at a site, as specified in the subject visit template. After the events occur, you update the information in the Siebel Subject Visit Schedule, and mark as complete the activities for subject visits.
Not applicable	Completion criteria	A set of parameters in Oracle Clinical. The parameters are based on responses to the following: visit, clinical planned event, received Data Collection Instrument, received Data Collection Module, or question responses that can be used to assign a completion date to an activity in Siebel Clinical.
Activity	Not applicable	In Siebel Clinical, required procedures or tasks in the visit schedule.