CM0 - Clinical Study Master Segment

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 Segment

Seq#	Data Element Name	DataType	Usage	Vocabulary	Cardinality	Item #	Length	C.LEN	Flags
CM0
1	Set ID - CM0	SI	O		[0..1]	01010	[1..4]
2	Sponsor Study ID	EI	R		[1..1]	01011
3	Alternate Study ID	EI	O		[0..3]	01036
4	Title of Study	ST	R		[1..1]	01013		300	#
5	Chairman of Study	XCN	O		[0..*]	01014
6	Last IRB Approval Date	DT	O		[0..1]	01015
7	Total Accrual to Date	NM	O		[0..1]	01016		8	#
8	Last Accrual Date	DT	O		[0..1]	01017
9	Contact for Study	XCN	O		[0..*]	01018
10	Contact's Telephone Number	XTN	O		[0..1]	01019
11	Contact's Address	XAD	O		[0..*]	01020

CM0-1: Set ID - CM0 (SI) 01010

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.

CM0-2: Sponsor Study ID (EI) 01011

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."

CM0-3: Alternate Study ID (EI) 01036

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

CM0-4: Title of Study (ST) 01013

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

CM0-5: Chairman of Study (XCN) 01014

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

CM0-6: Last IRB Approval Date (DT) 01015

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

CM0-7: Total Accrual to Date (NM) 01016

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

CM0-8: Last Accrual Date (DT) 01017

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

CM0-9: Contact for Study (XCN) 01018

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

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

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

CM0-11: Contact's Address (XAD) 01020

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