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CSR - Clinical Study Registration Segment (CSR)

Global Profile (Differential)
Seq#Data ElementDescriptionFlagsImplementVocabulary
CSR
101011Sponsor Study ID SHALL
401038Sponsor Patient ID  SHALL
601040Date/Time of Patient Study Registration SHALL
801042Study Authorizing Provider  SHALL
Global Profile (Snapshot)
Seq#Data ElementDescriptionFlagsImplementCardinalityVocabularyData Type
CSR
101011Sponsor Study ID SHALL[1..1]
EI

Entity Identifier

201036Alternate Study ID MAY[0..1]
EI

Entity Identifier

301037Institution Registering the Patient MAY[0..1]InstitutionRegisteringthePatient (CD)
CWE

Coded with Exceptions

401038Sponsor Patient ID  SHALL[1..1]
CX

Extended Composite ID with Check Digit

501039Alternate Patient ID - CSR MAY[0..1]
CX

Extended Composite ID with Check Digit

601040Date/Time of Patient Study Registration SHALL[1..1]
DTM

Date/Time

701041Person Performing Study Registration MAY[0..*]
XCN

Extended Composite ID Number and Name for Persons

801042Study Authorizing Provider  SHALL[1..*]
XCN

Extended Composite ID Number and Name for Persons


901043Date/Time Patient Study Consent Signed
C

Condition defined for this element

MAY[0..1]
DTM

Date/Time


1001044Patient Study Eligibility Status
C

Condition defined for this element

MAY[0..1]PatientStudyEligibilityStatus (CD)
CWE

Coded with Exceptions

1101045Study Randomization Date/time MAY[0..3]
DTM

Date/Time

1201046Randomized Study Arm MAY[0..3]RandomizedStudyArm (CD)
CWE

Coded with Exceptions

1301047Stratum for Study Randomization MAY[0..3]StratumforStudyRandomization (CD)
CWE

Coded with Exceptions


1401048Patient Evaluability Status
C

Condition defined for this element

MAY[0..1]PatientEvaluabilityStatus (CD)
CWE

Coded with Exceptions


1501049Date/Time Ended Study
C

Condition defined for this element

MAY[0..1]
DTM

Date/Time


1601050Reason Ended Study
C

Condition defined for this element

MAY[0..1]ReasonEndedStudy (CD)
CWE

Coded with Exceptions

1700816Action Code MAY[0..1]univ: SegmentActionCode (CD) hl7VS-segmentActionCode (VS) segmentAction (CS)
ID

Coded Value for HL7 Defined Tables