Draft Website - For Review Purposes Only

The Technical Steward for the CM1 segment is Orders and Observations.

Each Clinical Study Phase Master (CM1) segment contains the information about one phase of a study identified in the preceding CM0. This is an optional structure to be used if the study has more than one treatment or evaluation phase within it. The identification of study phases that the patient enters are sent in the CSP segment: sequence 2. The CM1 segment describes the phase in general for the receiving system.

HL7 Attribute Table - CM1 - Clinical Study Phase Master Segment

Seq#	DataElement	Description	Must Implement	Flags	Cardinality	Length	C.LEN	Vocabulary	DataType
CM1
1	01021	Set ID - CM1	SHALL		[1..1]	[1..4]			SI
2	01022	Study Phase Identifier	SHALL		[1..1]			0587	CWE
3	01023	Description of Study Phase	SHALL	=	[1..1]		300		ST

Definition: This field contains a number that uniquely identifies this transaction for the purpose of adding, changing, or deleting the transaction. For those messages that permit segments to repeat, the Set IF field is used to identify the repetitions.

(Definition from CSP.1 in Ch. 7)

Definition: This field identifies the phase of the study that a patient has entered. The set of codes will generally be developed for each clinical trial, although there are patterns that trials in particular disease or prevention categories may follow. The phase structure will be based on data collation and reporting needs for the study. It is an operational structure and need not be discussed in the clinical trial protocol documentation or even made known to patient care or data collection personnel. The coding system will usually be developed by the sponsor for multicentered clinical trials to standardize the receipt of automated data. Local codes could be added if an additional local message is desired. Otherwise, local coding conventions will be used. Refer to Table 0587 - Study Phase Identifier in Chapter 2C for valid values.

Example:

2^Init Rx, Crs 1^NCI T93-0807 Phases

(Definition from CTI.2 in Ch. 7)

Definition: This field identifies the phase of the study that a patient has entered. See CSP-1 Study Phase Identifier for details of coding systems. Refer to Table 0597 - Study Phase Identifier in Chapter 2C for valid values.

(Definition from CM1.2 in Ch. 8)

Definition: This field should correspond to the study phase ID coding system in Chapter 7, section 7.7.2.1, "Study Phase ID."

Definition: This field contains a brief explanation for recipients to understand what the phase represents.