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18.8.36 CTI - Clinical Trial Identification Segment (7.8.4)

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

Base Framework
Seq#Data ElementDescriptionFlagsImplementCardinalityLengthC.LENVocabularyData Type
CTI
101011Sponsor Study ID SHOULD[1..1] 
EI

Entity Identifier


201022Study Phase Identifier
C

Condition defined for this element

MAY[0..1] 
CWE

Coded with Exceptions

301055Study Scheduled Time Point MAY[0..1] StudyScheduledTimePoint (CD)
CWE

Coded with Exceptions

400816Action Code MAY[0..1][2..2]univ: SegmentActionCode (CD) hl7VS-segmentActionCode (VS) segmentAction (CS)
ID

Coded Value for HL7 Defined Tables

Conditions/Invariants

The root for the expression is on the segment.

Seq. Referenced Elements Introduction Invariant Comment
1 ?

Seq#Data ElementDescriptionFlagsImplementCardinalityLengthC.LENVocabularyData Type
CTI
101011Sponsor Study ID SHALL[1..1] 
EI

Entity Identifier


201022Study Phase Identifier
C

Condition defined for this element

MAY[0..1] 
CWE

Coded with Exceptions

301055Study Scheduled Time Point MAY[0..1] StudyScheduledTimePoint (CD)
CWE

Coded with Exceptions

400816Action Code MAY[0..1][2..2]univ: SegmentActionCode (CD) hl7VS-segmentActionCode (VS) segmentAction (CS)
ID

Coded Value for HL7 Defined Tables

Base FrameworkBase Standard Profile
Seq#Data ElementDescriptionFlagsImplementCardinalityLengthC.LENVocabularyData TypeImplementVocabulary
CTI 
101011Sponsor Study ID SHOULD[1..1] 
EI

Entity Identifier

SHALL

201022Study Phase Identifier
C

Condition defined for this element

MAY[0..1] 
CWE

Coded with Exceptions

MAY
301055Study Scheduled Time Point MAY[0..1] StudyScheduledTimePoint (CD)
CWE

Coded with Exceptions

MAY
400816Action Code MAY[0..1][2..2]univ: SegmentActionCode (CD) hl7VS-segmentActionCode (VS) segmentAction (CS)
ID

Coded Value for HL7 Defined Tables

MAY 
Base Framework Base Standard Profile
Seq# Data Element Description Flags Optionality Repetition Length C.LEN Table Data Type Optionality Table
CTI  
1 01011 Sponsor Study ID   O      
EI

Entity Identifier

R  

2 01022 Study Phase Identifier
C

Condition defined for this element

O      
CWE

Coded with Exceptions

   
3 01055 Study Scheduled Time Point   O      
CWE

Coded with Exceptions

  (0595)
4 00816 Action Code   O   [2..2]  
ID

Coded Value for HL7 Defined Tables

  (0206)
Seq# Data Element Description Optionality Repetition Length C.LEN Table Data Type
CTI
1 01011 Sponsor Study ID R      
EI

Entity Identifier

2 01022 Study Phase Identifier C      
CWE

Coded with Exceptions

3 01055 Study Scheduled Time Point O     (0595)
CWE

Coded with Exceptions

4 00816 Action Code O   [2..2] (0206)
ID

Coded Value for HL7 Defined Tables

18.8.36.1 CTI field definitions (7.8.4.0)

18.8.36.2 CTI-1 Sponsor Study ID (EI) 01011 (7.8.4.1)

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

18.8.36.3 CTI-2 Study Phase Identifier (CWE) 01022 (7.8.4.2)

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.

18.8.36.4 CTI-3 Study Scheduled Time Point (CWE) 01055 (7.8.4.3)

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.

18.8.36.5 CTI-4 Action Code (ID) 00816 (7.8.4.4)

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 CTI-1 is valued in accordance with the guidance in Chapter 2, Section 2.10.4.2.