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8.10.2 CM0 - clinical study master segment

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

8.10.2.1 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.

8.10.2.2 Sponsor study ID (CE) 01011

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."

8.10.2.3 Alternate study ID (CE) 01012

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.

8.10.2.4 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.

8.10.2.5 Chairman (XCN) 01014

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 institution’s chairman. It further identifies the study. The chairman’s name may be needed for communication purposes.

8.10.2.6 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.

8.10.2.7 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.

8.10.2.8 Last accrual date (DT) 01017

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

8.10.2.9 Contact for study (XCN) 01018

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.

8.10.2.10 Contact’s telephone (XTN) 01019

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

8.10.2.11 Contact's address (XAD) 01020

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.

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