HL7 CM0 Clinical Study Master
HL7 field reference CM0 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
| Field | Name | Required | Repeatable | Type | Table |
|---|---|---|---|---|---|
| CM0.1 | Set ID - CM0 | No | No | SI | |
| CM0.2 | Sponsor Study ID | Yes | No | EI | |
| CM0.3 | Alternate Study ID | No | Yes | EI | |
| CM0.4 | Title of Study | Yes | No | ST | |
| CM0.5 | Chairman of Study | No | Yes | XCN | |
| CM0.6 | Last IRB Approval Date | No | No | DT | |
| CM0.7 | Total Accrual to Date | No | No | NM | |
| CM0.8 | Last Accrual Date | No | No | DT | |
| CM0.9 | Contact for Study | No | Yes | XCN | |
| CM0.10 | Contact's Telephone Number | No | No | XTN | |
| CM0.11 | Contact's Address | No | Yes | XAD |
CM0 is the master record for a clinical study, carrying the study identifier, sponsor, chair, timing, and related administrative details.
The standard describes CM0 this way: The Clinical Study Master (CM0) segment contains the information about the study itself. The sending application study number for each patient is sent in the CSR segment. The optional CM0 enables information about the study at the sending application that may be useful to the receiving systems. All of the fields in the segment describe the study status at the sending facility unless otherwise agreed upon.
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 CM0 in MFN_M06 - Clinical study with phases and schedules master file, MFN_M07 - Clinical study without phases but with schedules master file, MFR_M06 - Clinical study with phases and schedules master file, and MFR_M07 - Clinical study without phases but with schedules master file. 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.
CM0-1 is the sequence number for this CM0 segment within its repeating group. It keeps multiple CM0 lines in order; it is not the business identifier for the study workflow.
CM0-2 identifies the Sponsor Study ID 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.
CM0-3 identifies the Alternate Study ID 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.
If there are several identifiers, use repetitions deliberately and make each repeat self-explanatory rather than relying on position alone.
CM0-4 carries Title of Study 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.
CM0-5 carries Chairman of Study 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.
This field can repeat. Use repetitions for separate real-world values, not as a workaround for putting several unrelated ideas in one field.
CM0-6 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.
CM0-7 is used for reconciliation. The receiver may compare it with the segments, batches, messages, rows, or items actually received, so do not populate it from a stale estimate.
CM0-8 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.
CM0-9 identifies a person, provider, staff member, or contact involved in this study workflow. Use the structured name or provider datatype instead of flattening everything into display text.
When more than one person is sent, repeats should carry role or identifier context so the receiver can tell who did what.
CM0-10 carries contact details. Use the datatype components for use code, equipment type, address type, country, and other qualifiers rather than squeezing everything into one formatted string.
CM0-11 carries contact details. Use the datatype components for use code, equipment type, address type, country, and other qualifiers rather than squeezing everything into one formatted string.
This field can repeat. Use repetitions for separate real-world values, not as a workaround for putting several unrelated ideas in one field.
Related links
- CM1 - Clinical Study Phase Master
- CM2 - Clinical Study Schedule Master
- CSR - Clinical Study Registration
- CSP - Clinical Study Phase
- CSS - Clinical Study Data Schedule Segment
- CTI - Clinical Trial Identification
- OBX - Observation/Result
- MFN_M06 - Clinical study with phases and schedules master file
- MFN_M07 - Clinical study without phases but with schedules master file
- MFR_M06 - Clinical study with phases and schedules master file