Design

The Design subsystem provides the facilities to model a clinical study after a study protocol. It provides a set of planning and recording facilities to handle diverse studies. No single study would use all its functions and options. Oracle Clinical provides two approaches to modeling a protocol: applying the Easy Study Design module, or applying the full complement of standard design modules.

During the early phases of study design, some details are often either unclear or disputed. For this reason, the Design subsystem enables you to design a study as a series of refinements. You can design the study's basic outlines early in its lifecycle, and refine it, exploring alternatives, until it matures into a fully operational study.

The following sections describe the major levels and components of this subsystem:

• Easy Study Design
  
• Standard Design
  

Easy Study Design

You can employ the Easy Study Design module—an integrated subset of the standard Design modules—to develop the fundamental details of a study to a testable stage of development. Oracle Clinical recommends that you begin creating a study with the Easy Study Design module, then clarify the details, as necessary, with the standard modules. If you have study planning privileges, you can create a planned study and a live study simultaneously. You also have the option to create or assign Intervals, planned events, treatment patterns, and patient positions.

Standard Design

Use the standard Design subsystem modules to refine the properties of a study originating in the Easy Study Design module, or to create new properties. The Design subsystem includes the following facilities:

Planning - At the planning level, you establish the organizational and geographic relationships for a new study and the program and project it belongs to.

Clinical Study - As the design of your study matures, you move it to the clinical study level. The clinical study record holds the basic details about the study.

Clinical Study Versions - A version is a variation on a proposed study design. Often basic study objectives and strategy are clear, but doubt remains about the effects that different stratifications, randomizations, or schedules of events might have on the results. Because a study has many variables, it is often difficult to predict which variation of a study would produce the clearest results. Clinical study versions contribute to solving this problem in two ways: (1) they facilitate building and comparing variations on one basic study design; (2) they permit altering one component, such as the stratification, without redesigning the entire study.

Planned Study Intervals - The planned study Intervals in a study make up the study timeline. A timeline is composed of phases, divided into periods, further divided into sub-periods. Each of these represents a planned study Interval.

Clinical Planned Events and Clinical Processes - A clinical process is a name for a type of visit in a study, such as a normal dosing visit. The clinical process is then used to describe the clinical planned event (CPE). A clinical process can be scheduled to occur several times within a study.

Treatment Patterns - A study's treatment patterns—one or more treatment regimens in a particular sequence—specify the drugs and medical procedures. You can assign a patient to a treatment pattern and then follow the course of treatment specified by the treatment regimens during parts of the study.

Patient Positions - With patient positions you specify the number of screening patients, "normal" patients, and replacement patients in the study.

Blinding - Details of pattern assignment are usually kept secret until after completion of a study's inclusion/exclusion process. If an Investigator discovers details of the pattern for a patient, creating a blind break, Oracle Clinical provides facilities to record and report it.

Stratification - Strata are groups of people with a common characteristic. Stratifying your patient population ensures the soundness of the analysis of the study's results.

Randomization - Oracle Clinical provides four randomization styles you can apply to the distribution of treatments among the study's patients. The randomization modules include facilities for bringing randomization data into or out of the Oracle Clinical database.