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, sites are created 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 the investigator on the study is associated with. 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 is 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 recruited by investigators. Patients participate in a clinical trial at a study site.

Subject visit template

Data Collection Instrument (DCI) Book

The expected events that are conducted 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, defined in the subject visit template. After the events occur, the information in the Siebel Subject Visit Schedule is updated, and the activities for subject visits are marked as complete.

Not applicable

Completion criteria

A set of parameters that is defined 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.