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CTI - Clinical Trial Identification Segment

The CTI segment is an optional segment that contains information to identify the clinical trial, phase and time point with which an order or result is associated.

HL7 Attribute Table - CTI - Clinical Trial Identification Segment
Seq# DataElement Description Must Implement Flags Cardinality Length C.LEN Vocabulary DataType
CTI
1 01011 Sponsor Study ID SHALL [1..1] EI
2

01022 Study Phase Identifier MAY
True:
False:
C
[1..1]
[0..1]
CWE
3 01055 Study Scheduled Time Point [0..1] CWE
4 00816 Action Code [0..1] [2..2] ID

CTI-1: Sponsor Study ID (EI) 01011

(Definition from CSR.1 in Ch. 7)

Definition: The field contains the universal identifier for the clinical trial. Since many clinical trials are collaborative and multi-centered, and since one goal of these standards is to promote automated data exchange among sites, the primary identifier should come from the sponsor. The coding system component may reference the sponsor. Example:

T93-0807^NCI (where NCI refers to the National Cancer Institute).

(Definition from CTI.1 in Ch. 7)

Definition: This field contains the universal identifier for the clinical trial. The coding system is as described in CSR-1 Sponsor Study ID.

(Definition from CM0.2 in Ch. 8)

Definition: This field contains the study number established by the study sponsor. Please see discussion in Chapter 7, section 7.7.1.1, "Sponsor study ID."

CTI-2: Study Phase Identifier (CWE) 01022

(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."

CTI-3: Study Scheduled Time Point (CWE) 01055

(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.

CTI-4: Action Code (ID) 00816

(Definition from OH1.2 in Ch. 3)

Definition: This field contains a code defining the action to be taken for this segment. It allows this segment to be sent to delete or update, for example, previously sent information. Refer to HL7 Table 0206 – Segment Action Code in Chapter 2C, Code Tables, for valid values.

(Definition from OH2.2 in Ch. 3)

Definition: This field contains a code defining the action to be taken for this segment. It allows this segment to be sent to delete or update, for example, previously sent information. Refer to HL7 Table 0206 – Segment Action Code in Chapter 2C, Code Tables, for valid values.

(Definition from OH3.2 in Ch. 3)

Definition: This field contains a code defining the action to be taken for this segment. It allows this segment to be sent to delete or update, for example, previously sent information. Refer to HL7 Table 0206 – Segment Action Code in Chapter 2C, Code Tables, for valid values.

(Definition from OH4.2 in Ch. 3)

Definition: This field contains a code defining the action to be taken for this segment. It allows this segment to be sent to delete or update, for example, previously sent information. Refer to HL7 Table 0206 – Segment Action Code in Chapter 2C, Code Tables, for valid values.

(Definition from ORC.35 in Ch. 4)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when either ORC-2 and/or ORC 3 is valued with a unique identifier in accordance with Chapter 2, Section 2.10.4.2.

(Definition from OBR.55 in Ch. 4)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when either an OBR-2 and/or OBR-3 is valued with unique identifier in accordance with Chapter 2, Section 2.10.4.2.

(Definition from IPC.10 in Ch. 4)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when the combination of IPC-1, IPC-2, IPC-3, and IPC-4 represents a unique identifier according to Chapter 2, Section 2.10.4.2.

(Definition from BPX.22 in Ch. 4)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when an BPX is uniquely identified sufficiently within the specific implementation using BPX-17 or BPX-6 as agreed to by the trading partners and in accordance with Chapter 2, Section 2.10.4.2.

(Definition from BTX.21 in Ch. 4)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when an BTX is uniquely identified sufficiently within the specific implementation using BTX-20 or BTX-3 as agreed to by the trading partners in accordance with Chapter 2, Section 2.10.4.2.

(Definition from DON.34 in Ch. 4)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when an DON is uniquely identified sufficiently within the specific implementation using DON-1 in accordance with Chapter 2, Section 2.10.4.2.

(Definition from BUI.13 in Ch. 4)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when an BUI is uniquely identified sufficiently within the specific implementation using BUI-2 in accordance with Chapter 2, Section 2.10.4.2

(Definition from RXV.22 in Ch. 4A)

Definition: The intended handling by the receiver of the infusion order is represented by this segment. Refer to HL7 Table 0206 – Segment Action Code in Chapter 2C, Code Tables, for valid values.

(Definition from CDO.2 in Ch. 4A)

Definition: The Action Code indicates whether the cumulative dosage segment is intended to be added, deleted, updated, or did not change. If the field is not valued in any CDO segments for the order, the segments are considered to have been sent in snapshot mode. If some but not all CDO segments for the order do not have the action code valued, the default value is Add. Refer to HL7 Table 0206 - Segment Action Code in Chapter 2C, Code Tables, for valid values.

(Definition from OBR.55 in Ch. 7)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when an either OBR-2 and/or OBR-3 is valued with unique identifier in accordance with Chapter 2, Section 2.10.4.2.

(Definition from OBX.31 in Ch. 7)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when an OBX-21 is valued in accordance with guidance in Chapter 2, Section 2.10.4.2.

(Definition from SPM.35 in Ch. 7)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when an SPM-2 or SPM-31 is valued in accordance with the guidance in Chapter 2, Section 2.10.4.2.

(Definition from PRT.2 in Ch. 7)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0287 – Problem/goal action code for valid values.

(Definition from CSR.17 in Ch. 7)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when CSR-1 and CSR-4, or CSR-2 and CSR-5 are valued as agreed to by the trading partners in accordance with the guidance in Chapter 2, Section 2.10.4.2.

(Definition from CTI.4 in Ch. 7)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when CTI-1 is valued in accordance with the guidance in Chapter 2, Section 2.10.4.2.

(Definition from SHP.12 in Ch. 7)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when SHP-1 is valued in accordance with the guidance in Chapter 2, Section 2.10.4.2.

(Definition from PAC.9 in Ch. 7)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when PAC-2 is valued in accordance with the guidance in Chapter 2, Section 2.10.4.2.

(Definition from GOL.1 in Ch. 12)

Definition: The action code field gives the intent of the problem or goal. Refer to HL7 Table 0287 – Problem/Goal Action Code in Chapter 2C, Code Tables, for valid values.

(Definition from PRB.1 in Ch. 12)

Definition: This field contains the intent of the message. Refer to HL7 Table 0287 – Problem/Goal Action Code in Chapter 2C, Code Tables, for valid values.

(Definition from PTH.1 in Ch. 12)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0287 – Problem/Goal Action Code in Chapter 2C, Code Tables, for valid values.

(Definition from DEV.1 in Ch. 17)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0287 – Problem/goal action code for valid values.