HL7 CSP Clinical Study Phase

Clinical study and trial fields from experience.
HL7 field reference CSP fields from HL7 v2.5.1 Show fields

These are the generated fields for the version selected at the top of the page. The document stays the same, but the reference panel follows that version.

Fields

FieldNameRequiredRepeatableTypeTable
CSP.1 Study Phase Identifier Yes No CE
CSP.2 Date/time Study Phase Began Yes No TS
CSP.3 Date/time Study Phase Ended No No TS
CSP.4 Study Phase Evaluability No No CE

CSP identifies the clinical-study phase attached to a patient, study event, or product-experience message.

The standard describes CSP this way: The CSP segment contains information on a patient's status for a particular phase of the study. This segment is optional and is useful when a study has different evaluation intervals within it. The CSP segment is implemented on a study specific basis for messaging purposes. The fact that the patient has entered a phase of the study that represents a certain treatment approach may need to be messaged to other systems, like pharmacy, nursing, or order entry. It is also important to sponsors and data management centers for tracking patient progress through the study and monitoring the data schedule defined for each phase. It may subsume OBR and OBX segments that follow it to indicate that these data describe the phase.

Clinical-study segments tie a message back to a trial, phase, schedule, subject registration, and protocol-specific events. They are not general observation notes; they support trial governance and reporting.

The useful data is usually the combination of study identifiers, phase identifiers, schedule timing, and subject status. Keep protocol codes and local study IDs aligned with the system that is managing the trial.

The v2.5.1 structures show CSP in CRM_C01 - CRM - Register a patient on a clinical trial, CSU_C09 - CSU - Automated time intervals for reporting like monthly, and PEX_P07 - PEX - Unsolicited initial individual product experience report. That tells you where it can appear, but the implementation guide still decides which optional fields are meaningful.

For practical interface work, read the generated field panel for datatype, required, repeatable, and table details, then use the notes below to decide what the field should mean in the receiving workflow.

CSP-1 Study Phase Identifier RequiredR SingleS TypeCE

CSP-1 identifies the Study Phase Identifier for this study workflow. Send the identifier that the receiving system actually keys on, and keep the assigning authority or coding system visible when the datatype supports it.

CSP-2 Date/time Study Phase Began RequiredR SingleS TypeTS

CSP-2 is a timing field. Send the real source-system precision, do not pad unknown dates or times, and agree how timezone offsets are handled when time of day matters.

CSP-3 Date/time Study Phase Ended OptionalO SingleS TypeTS

CSP-3 is a timing field. Send the real source-system precision, do not pad unknown dates or times, and agree how timezone offsets are handled when time of day matters.

CSP-4 Study Phase Evaluability OptionalO SingleS TypeCE

CSP-4 carries Study Phase Evaluability for this study workflow. Populate it only when the receiver has a clear use for it, and keep the value in the datatype shape shown in the generated field panel.

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