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.
Figure 8-20. CM0 attributes
SEQ |
LEN |
DT |
OPT |
RP/# |
TBL# |
ITEM# |
ELEMENT NAME |
1 |
4 |
SI |
O |
01010 |
Set ID - CM0 |
||
2 |
60 |
CE |
R |
01011 |
Sponsor Study ID |
||
3 |
60 |
CE |
O |
Y/3 |
01012 |
Alternate Study ID's |
|
4 |
300 |
ST |
R |
01013 |
Title of Study |
||
5 |
60 |
XCN |
O |
01014 |
Chairman of Study |
||
6 |
8 |
DT |
O |
01015 |
Last IRB Approval Date |
||
7 |
8 |
NM |
O |
01016 |
Total Accrual to Date |
||
8 |
8 |
DT |
O |
01017 |
Last Accrual Date |
||
9 |
60 |
XCN |
O |
01018 |
Contact for Study |
||
10 |
40 |
XTN |
O |
01019 |
Contact's Tel. Number |
||
11 |
100 |
XAD |
O |
01020 |
Contact's Address |
8.10.2.0 CM0 field definitions
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.
Components: <identifier (ST)> ^ <text (ST)> ^ <name of coding system (ST)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^ <name of alternate coding system (ST)>
Definition: This field contains the study number established by the study sponsor. Please see discussion in Section 7.7.1.1, "Sponsor study ID."
Components: <identifier (ST)> ^ <text (ST)> ^ <name of coding system (ST)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^ <name of alternate coding system (ST)>
Definition: This field contains the local or collaborators cross-referenced study numbers.
Definition: This field contains the sending institutions title for the clinical trial. It gives recipients further identification of the study.
Components: <ID number (ST)> ^ <family name (ST)> ^ <given name (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR or III) (ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (ST)> ^ <source table (IS)> ^ <assigning authority (HD)> ^ <name type (ID)> ^ <identifier check digit (ST)> ^ <code identifying the check digit scheme employed (ID) ^ <identifier type code (IS)> ^ <assigning facility ID (HD)>
Subcomponents of assigning authority: <namespace ID (IS)> & <universal ID (ST)> & <universal ID type (ID)>
Subcomponents of assigning facility ID: <namespace ID (IS)> & <universal ID (ST)> & <universal ID type (ID)>
Definition: This field contains the sending institutions chairman. It further identifies the study. The chairmans name may be needed for communication purposes.
Definition: This field contains an institutions 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.
Components: <ID number (ST)> ^ <family name (ST)> ^ <given name (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR or III) (ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (ST)> ^ <source table (IS)> ^ <assigning authority (HD)> ^ <name type (ID)> ^ <identifier check digit (ST)> ^ <code identifying the check digit scheme employed (ID) ^ <identifier type code (IS)> ^ <assigning facility ID (HD)>
Subcomponents of assigning authority: <namespace ID (IS)> & <universal ID (ST)> & <universal ID type (ID)>
Subcomponents of assigning facility ID: <namespace ID (IS)> & <universal ID (ST)> & <universal ID type (ID)>
Definition: This field contains the name of the individual who should be contacted for inquiries about data transmitted for this study.
Components: [NNN] [(999)]999-9999 [X9999] [C any text] ^ <telecommunication use code (ID)> ^ <telecommunication equipment type (ID)> ^ <email address (ST)> ^ <county code (NM)> ^ <area/city code (NM)> ^ <phone number (NM)> ^ <extension (NM)> ^ <any test (ST)>
Definition: This field contains the phone number of the study contact identified in CM0-9-contact for study
Components: <street address (ST)> ^ <other designation (ST)> ^ <city (ST)> ^ <state or province (ST)> ^ <zip or postal code (ST)> ^ <country (ID)> ^ <address type (ID)> ^ <other geographic designation (ST)> ^ <county/parish code (IS)> ^ <census tract (IS)>
Definition: This field contains the address of the study contact identified in CM0-9contact for study.