Global Profile (Differential) | ||||||||||
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Seq# | Data Element | Description | Flags | Implement | Vocabulary | |||||
CSR | ||||||||||
1 | 01011 | Sponsor Study ID | SHALL | |||||||
4 | 01038 | Sponsor Patient ID | SHALL | |||||||
6 | 01040 | Date/Time of Patient Study Registration | SHALL | |||||||
8 | 01042 | Study Authorizing Provider | SHALL |
Global Profile (Snapshot) | ||||||||||
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Seq# | Data Element | Description | Flags | Implement | Cardinality | Vocabulary | Data Type | |||
CSR | ||||||||||
1 | 01011 | Sponsor Study ID | SHALL | [1..1] | EI Entity Identifier | |||||
2 | 01036 | Alternate Study ID | MAY | [0..1] | EI Entity Identifier | |||||
3 | 01037 | Institution Registering the Patient | MAY | [0..1] | InstitutionRegisteringthePatient (CD) | CWE Coded with Exceptions | ||||
4 | 01038 | Sponsor Patient ID | SHALL | [1..1] | CX Extended Composite ID with Check Digit | |||||
5 | 01039 | Alternate Patient ID - CSR | MAY | [0..1] | CX Extended Composite ID with Check Digit | |||||
6 | 01040 | Date/Time of Patient Study Registration | SHALL | [1..1] | DTM Date/Time | |||||
7 | 01041 | Person Performing Study Registration | MAY | [0..*] | XCN Extended Composite ID Number and Name for Persons | |||||
8 | 01042 | Study Authorizing Provider | SHALL | [1..*] | XCN Extended Composite ID Number and Name for Persons | |||||
9 | 01043 | Date/Time Patient Study Consent Signed | C Condition defined for this element | MAY | [0..1] | DTM Date/Time | ||||
10 | 01044 | Patient Study Eligibility Status | C Condition defined for this element | MAY | [0..1] | PatientStudyEligibilityStatus (CD) | CWE Coded with Exceptions | |||
11 | 01045 | Study Randomization Date/time | MAY | [0..3] | DTM Date/Time | |||||
12 | 01046 | Randomized Study Arm | MAY | [0..3] | RandomizedStudyArm (CD) | CWE Coded with Exceptions | ||||
13 | 01047 | Stratum for Study Randomization | MAY | [0..3] | StratumforStudyRandomization (CD) | CWE Coded with Exceptions | ||||
14 | 01048 | Patient Evaluability Status | C Condition defined for this element | MAY | [0..1] | PatientEvaluabilityStatus (CD) | CWE Coded with Exceptions | |||
15 | 01049 | Date/Time Ended Study | C Condition defined for this element | MAY | [0..1] | DTM Date/Time | ||||
16 | 01050 | Reason Ended Study | C Condition defined for this element | MAY | [0..1] | ReasonEndedStudy (CD) | CWE Coded with Exceptions | |||
17 | 00816 | Action Code | MAY | [0..1] | univ: SegmentActionCode (CD) hl7VS-segmentActionCode (VS) segmentAction (CS) | ID Coded Value for HL7 Defined Tables |