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.
|1||01010||Set ID - CM0||[0..1]||[1..4]||SI|
|2||01011||Sponsor Study ID||SHALL||[1..1]||EI|
|3||01036||Alternate Study ID||[0..3]||EI|
|4||01013||Title of Study||SHALL||#||[1..1]||300||ST|
|5||01014||Chairman of Study||[0..*]||XCN|
|6||01015||Last IRB Approval Date||[0..1]||DT|
|7||01016||Total Accrual to Date||=||[0..1]||8||NM|
|8||01017||Last Accrual Date||[0..1]||DT|
|9||01018||Contact for Study||[0..*]||XCN|
|10||01019||Contact's Telephone Number||[0..1]||XTN|
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.
(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 184.108.40.206, "Sponsor study ID."
(Definition from CSR.2 in Ch. 7)
Definition: This field contains an alternate identifier that may be used as agreed upon by messaging parties. For example, the sending application may code its internal study number here.
(Definition from CM0.3 in Ch. 8)
Definition: This field contains the local or collaborators' cross-referenced study numbers.
Definition: This field contains the sending institution's title for the clinical trial. It gives recipients further identification of the study.
Definition: This field contains the sending institution's chairman. It further identifies the study. The chairman's name may be needed for communication purposes.
Definition: This field contains an institution's Internal Review Board approval dates which are required annually to continue participation in a clinical trial.
Definition: This field is a quality control field to enable checks that patient data have been transmitted on all registered patients.
Definition: This field contains the status information on the patient registration activity for quality control and operations purposes.
Definition: This field contains the name of the individual who should be contacted for inquiries about data transmitted for this study.
Definition: This field contains the phone number of the study contact identified in CM0-9 - Contact for Study.
Definition: This field contains the address of the study contact identified in CM0-9 - Contact for Study.