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18.8.27 CM0 - Clinical Study Master Segment (8.11.2)

The Technical Steward for the CM0 segment is Orders and Observations.

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.

HL7 Attribute Table - CM0 - Clinical Study Master

Base Framework
Seq#Data ElementDescriptionFlagsImplementCardinalityLengthC.LENVocabularyData Type
CM0
101010Set ID - CM0 MAY[0..1][1..4]
SI

Sequence ID

201011Sponsor Study ID SHOULD[1..1] 
EI

Entity Identifier

301036Alternate Study ID MAY[0..3] 
EI

Entity Identifier

401013Title of Study
=

Truncation allowed.

SHOULD[1..1] 300
ST

String Data

501014Chairman of Study MAY[0..*] 
XCN

Extended Composite ID Number and Name for Persons

601015Last IRB Approval Date MAY[0..1] 
DT

Date

701016Total Accrual to Date
=

Truncation not allowed!

MAY[0..1] 8
NM

Numeric

801017Last Accrual Date MAY[0..1] 
DT

Date

901018Contact for Study MAY[0..*] 
XCN

Extended Composite ID Number and Name for Persons

1001019Contact's Telephone Number MAY[0..1] 
XTN

Extended Telecommunication Number

1101020Contact's Address MAY[0..*] 
XAD

Extended Address

Seq#Data ElementDescriptionFlagsImplementCardinalityLengthC.LENVocabularyData Type
CM0
101010Set ID - CM0 MAY[0..1][1..4]
SI

Sequence ID

201011Sponsor Study ID SHALL[1..1] 
EI

Entity Identifier

301036Alternate Study ID MAY[0..3] 
EI

Entity Identifier

401013Title of Study
=

Truncation allowed.

SHALL[1..1] 300
ST

String Data

501014Chairman of Study MAY[0..*] 
XCN

Extended Composite ID Number and Name for Persons

601015Last IRB Approval Date MAY[0..1] 
DT

Date

701016Total Accrual to Date
=

Truncation not allowed!

MAY[0..1] 8
NM

Numeric

801017Last Accrual Date MAY[0..1] 
DT

Date

901018Contact for Study MAY[0..*] 
XCN

Extended Composite ID Number and Name for Persons

1001019Contact's Telephone Number MAY[0..1] 
XTN

Extended Telecommunication Number

1101020Contact's Address MAY[0..*] 
XAD

Extended Address

Base FrameworkBase Standard Profile
Seq#Data ElementDescriptionFlagsImplementCardinalityLengthC.LENVocabularyData TypeImplementVocabulary
CM0 
101010Set ID - CM0 MAY[0..1][1..4]
SI

Sequence ID

MAY
201011Sponsor Study ID SHOULD[1..1] 
EI

Entity Identifier

SHALL
301036Alternate Study ID MAY[0..3] 
EI

Entity Identifier

MAY
401013Title of Study
=

Truncation allowed.

SHOULD[1..1] 300
ST

String Data

SHALL
501014Chairman of Study MAY[0..*] 
XCN

Extended Composite ID Number and Name for Persons

MAY
601015Last IRB Approval Date MAY[0..1] 
DT

Date

MAY
701016Total Accrual to Date
=

Truncation not allowed!

MAY[0..1] 8
NM

Numeric

MAY
801017Last Accrual Date MAY[0..1] 
DT

Date

MAY
901018Contact for Study MAY[0..*] 
XCN

Extended Composite ID Number and Name for Persons

MAY
1001019Contact's Telephone Number MAY[0..1] 
XTN

Extended Telecommunication Number

MAY
1101020Contact's Address MAY[0..*] 
XAD

Extended Address

MAY
Base Framework Base Standard Profile
Seq# Data Element Description Flags Optionality Repetition Length C.LEN Table Data Type Optionality Table
CM0  
1 01010 Set ID - CM0   O   [1..4]  
SI

Sequence ID

   
2 01011 Sponsor Study ID   O      
EI

Entity Identifier

R  
3 01036 Alternate Study ID   O Y/3    
EI

Entity Identifier

   
4 01013 Title of Study   O     300#  
ST

String Data

R  
5 01014 Chairman of Study   O Y    
XCN

Extended Composite ID Number and Name for Persons

   
6 01015 Last IRB Approval Date   O      
DT

Date

   
7 01016 Total Accrual to Date   O     8=  
NM

Numeric

   
8 01017 Last Accrual Date   O      
DT

Date

   
9 01018 Contact for Study   O Y    
XCN

Extended Composite ID Number and Name for Persons

   
10 01019 Contact's Telephone Number   O      
XTN

Extended Telecommunication Number

   
11 01020 Contact's Address   O Y    
XAD

Extended Address

   
Seq# Data Element Description Optionality Repetition Length C.LEN Table Data Type
CM0
1 01010 Set ID - CM0 O   [1..4]  
SI

Sequence ID

2 01011 Sponsor Study ID R      
EI

Entity Identifier

3 01036 Alternate Study ID O Y/3    
EI

Entity Identifier

4 01013 Title of Study R     300#  
ST

String Data

5 01014 Chairman of Study O Y    
XCN

Extended Composite ID Number and Name for Persons

6 01015 Last IRB Approval Date O      
DT

Date

7 01016 Total Accrual to Date O     8=  
NM

Numeric

8 01017 Last Accrual Date O      
DT

Date

9 01018 Contact for Study O Y    
XCN

Extended Composite ID Number and Name for Persons

10 01019 Contact's Telephone Number O      
XTN

Extended Telecommunication Number

11 01020 Contact's Address O Y    
XAD

Extended Address

18.8.27.1 CM0 Field Definitions (8.11.2.0)

18.8.27.2 CM0-1 Set ID - CM0 (SI) 01010 (8.11.2.1)

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 ID field is used to identify the repetitions.

18.8.27.3 CM0-2 Sponsor Study ID (EI) 01011 (8.11.2.2)

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."

18.8.27.4 CM0-3 Alternate Study ID (EI) 01036 (8.11.2.3)

Definition: This field contains the local or collaborators' cross-referenced study numbers.

18.8.27.5 CM0-4 Title of Study (ST) 01013 (8.11.2.4)

Definition: This field contains the sending institution's title for the clinical trial. It gives recipients further identification of the study.

18.8.27.6 CM0-5 Chairman of Study (XCN) 01014 (8.11.2.5)

Definition: This field contains the sending institution's chairman. It further identifies the study. The chairman's name may be needed for communication purposes.

18.8.27.7 CM0-6 Last IRB Approval Date (DT) 01015 (8.11.2.6)

Definition: This field contains an institution's Internal Review Board approval dates which are required annually to continue participation in a clinical trial.

18.8.27.8 CM0-7 Total Accrual to Date (NM) 01016 (8.11.2.7)

Definition: This field is a quality control field to enable checks that patient data have been transmitted on all registered patients.

18.8.27.9 CM0-8 Last Accrual Date (DT) 01017 (8.11.2.8)

Definition: This field contains the status information on the patient registration activity for quality control and operations purposes.

18.8.27.10 CM0-9 Contact for Study (XCN) 01018 (8.11.2.9)

Definition: This field contains the name of the individual who should be contacted for inquiries about data transmitted for this study.

18.8.27.11 CM0-10 Contact's Telephone Number (XTN) 01019 (8.11.2.10)

Definition: This field contains the phone number of the study contact identified in CM0-9 - Contact for Study.

18.8.27.12 CM0-11 Contact's Address (XAD) 01020 (8.11.2.11)

Definition: This field contains the address of the study contact identified in CM0-9 - Contact for Study.