The phase structure serves several purposes in the clinical trials messages. Other computer systems may need to know that the patient has begun a phase with a particular treatment regimen or diagnostic schedule, such as the pharmacy or order entry systems. When reporting study data, observations and variables often describe particular phase instances. For example, each course of treatment may have its own values for the same set of observations or variables. Phase instances may also have distinct data schedules that need to be linked to submitted data.
Several examples follow with each line depicting a phase.
Rx A Rx B Rx A Rx B 7.5.1.2.2 Example 2 Random assignment to two courses each of treatment A or B, all responding patients to treatment C, continue with observation and a diagnostic regimen after all treatment phases are completed. As data are reported, they may need to reflect the scheduled time point that they satisfy. Clinical trials quality control requires attention to compliance between the protocol's schedule and patient data records. The data schedule will be keyed by time points relative to the study. Some are interim within the study or its phases depending on protocol events such as administration of treatment, arbitrary time intervals instated to make and record assessments, or some clinical milestone such as relapse of disease.