The Clinical Study Data Schedule (CSS) segment is optional depending on whether messaging of study data needs to be linked to the scheduled data time points for the study. (See Section 188.8.131.52, "Data schedule:".) The CSS segment enables communication of data schedules and adherence that ranges from the basic to the elaborate. Use of the segment must be planned for each implementation. Each CSS segment will subsume observation and drug administration segments that follow, indicating that they satisfy this scheduled time point.
|1||01055||Study Scheduled Time Point||SHALL||[1..1]||CWE|
|2||01056||Study Scheduled Patient Time Point||[0..1]||DTM|
|3||01057||Study Quality Control Codes||[0..3]||CWE|
(Definition from CSS.1 in Ch. 7)
Definition: This field contains the time point for which some instance of data for the clinical trial was scheduled. The time point may be expressed in any coded format. Some examples of time point values are: Prestudy, Pretreatment, 4 times/day, Weekly, Every 3 days, Every course, At Relapse, At Off Study. Alternatively, frequency values from Section 2.A.81.2, "Interval component (RI)," (the Interval component of the TQ Timing/Quantity data type could be used; however, note that as of version 2.5, the TQ data type is retained only for backward compatibility). Time point naming conventions and usage must be specified by implementers. Refer to Table 0595 - Study Scheduled Time Point in Chapter 2C for valid values.
(Definition from CTI.3 in Ch. 7)
Definition: This field identifies a time point in the clinical trial phase. CTI-2 Study Phase Identifier must be valued if CTI-3 Study Scheduled Time Point is valued. Should correspond to CSS-1 Study Scheduled Time Point. Refer to Table 0598 - Study Scheduled Time Point in Chapter 2C for valid values.
Definition: This field contains the date/time that the scheduled time point should occur for this patient. The date/time may be used for a reference in reviewing the actual dates on which scheduled items that follow in OBR segments occur for the patient. The time component is optional.
Definition: In clinical settings, the actual date of a treatment or procedure may vary considerably from the due date. Various coding systems may be used to evaluate the adherence to the schedule or acceptability of the data. Coding systems will vary among trials. Refer to Table 0596 - Study Quality Control Codes in Chapter 2C for valid values.