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Observation Class: Special Purpose - Domain: Subject Elements

59 forms  
  1. StudyEvent: ODM
    1. Observation Class: Special Purpose - Domain: Comments
    2. Observation Class: Special Purpose - Domain: Demographics
    3. Observation Class: Special Purpose - Domain: Subject Elements
    4. Observation Class: Special Purpose - Domain: Subject Disease Milestones
    5. Observation Class: Special Purpose - Domain: Subject Visits
    6. Observation Class: Interventions - Domain: Procedure Agents
    7. Observation Class: Interventions - Domain: Concomitant/Prior Medications
    8. Observation Class: Interventions - Domain: Exposure
    9. Observation Class: Interventions - Domain: Exposure as Collected
    10. Observation Class: Interventions - Domain: Meal Data
    11. Observation Class: Interventions - Domain: Procedures
    12. Observation Class: Interventions - Domain: Substance Use
    13. Observation Class: Events - Domain: Adverse Events
    14. Observation Class: Events - Domain: Clinical Events
    15. Observation Class: Events - Domain: Disposition
    16. Observation Class: Events - Domain: Protocol Deviations
    17. Observation Class: Events - Domain: Healthcare Encounters
    18. Observation Class: Events - Domain: Medical History
    19. Observation Class: Findings - Domain: Drug Accountability
    20. Observation Class: Findings - Domain: Death Details
    21. Observation Class: Findings - Domain: ECG Test Results
    22. Observation Class: Findings - Domain: Inclusion/Exclusion Criteria Not Met
    23. Observation Class: Findings - Domain: Immunogenicity Specimen Assessments
    24. Observation Class: Findings - Domain: Laboratory Test Results
    25. Observation Class: Findings - Domain: Microbiology Specimen
    26. Observation Class: Findings - Domain: Microbiology Susceptibility
    27. Observation Class: Findings - Domain: Microscopic Findings
    28. Observation Class: Findings - Domain: Morphology
    29. Observation Class: Findings - Domain: Cardiovascular System Findings
    30. Observation Class: Findings - Domain: Musculoskeletal System Findings
    31. Observation Class: Findings - Domain: Nervous System Findings
    32. Observation Class: Findings - Domain: Ophthalmic Examinations
    33. Observation Class: Findings - Domain: Reproductive System Findings
    34. Observation Class: Findings - Domain: Respiratory System Findings
    35. Observation Class: Findings - Domain: Urinary System Findings
    36. Observation Class: Findings - Domain: Pharmacokinetics Concentrations
    37. Observation Class: Findings - Domain: Pharmacokinetics Parameters
    38. Observation Class: Findings - Domain: Physical Examination
    39. Observation Class: Findings - Domain: Functional Tests
    40. Observation Class: Findings - Domain: Questionnaires
    41. Observation Class: Findings - Domain: Disease Response and Clin Classification
    42. Observation Class: Findings - Domain: Subject Characteristics
    43. Observation Class: Findings - Domain: Subject Status
    44. Observation Class: Findings - Domain: Tumor/Lesion Identification
    45. Observation Class: Findings - Domain: Tumor/Lesion Results
    46. Observation Class: Findings - Domain: Vital Signs
    47. Observation Class: Findings - Domain: Findings About Events or Interventions
    48. Observation Class: Findings - Domain: Skin Response
    49. Observation Class: Trial Design - Domain: Trial Arms
    50. Observation Class: Trial Design - Domain: Trial Elements
    51. Observation Class: Trial Design - Domain: Trial Visits
    52. Observation Class: Trial Design - Domain: Trial Disease Assessments
    53. Observation Class: Trial Design - Domain: Trial Disease Milestones
    54. Observation Class: Trial Design - Domain: Trial Inclusion/Exclusion Criteria
    55. Observation Class: Trial Design - Domain: Trial Summary Information
    56. Observation Class: Relationships - Domain: Related Records
    57. Observation Class: Relationships - Domain: Supplemental Qualifiers for [domain name]
    58. Observation Class: Relationships - Domain: Related Subjects
    59. Observation Class: Study Reference - Domain: Non-host Organism Identifiers
Subject Elements
Description

Subject Elements

Alias
SDTMIG v3.3
SE
UMLS CUI-1
C1705189
NCIt V19.10d:
C49616
Study Identifier
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Unique identifier for a study. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1]
C2826693
SDTMIG 3.3
STUDYID
NCIt V19.10d
C83082
Domain Abbreviation
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain. Controlled Terms or Format (if applicable): SE

Data type

text

Alias
UMLS CUI [1]
C0000723
SDTMIG 3.3
DOMAIN
NCIt V19.10d
C49556
Unique Subject Identifier
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1710548
UMLS CUI [1,2]
C2826693
SDTMIG 3.3
USUBJID
NCIt V19.10d
C70731
Sequence Number
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sequence number given to ensure uniqueness of subject records within a domain. Should be assigned to be consistent chronological order. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C1705189
UMLS CUI [1,2]
C2348184
SDTMIG 3.3
SESEQ
NCIt V19.10d
C87999
Element Code
Description

Role: Topic CDISC Notes (for domains) Description (for General Classes): 1. ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name. 2. If an encountered Element differs from the planned Element to the point that it is considered a new Element, then use "UNPLAN" as the value for ETCD to represent this Element. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C3812827
UMLS CUI [1,2]
C0805701
SDTMIG 3.3
ETCD
NCIt V19.10d
C83275
Description of Element
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT should be null. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C3812827
SDTMIG 3.3
ELEMENT
NCIt V19.10d
C105752
Planned Order of Element within Arm
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Number that gives the planned order of the Element within the subject's assigned Arm. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C3812827
UMLS CUI [1,3]
C1705175
UMLS CUI [1,4]
C1522541
SDTMIG 3.3
TAETORD
NCIt V19.10d
C83438
Epoch
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Epoch associated with the Element in the planned sequence of Elements for the Arm to which the subject was assigned. Controlled Terms or Format (if applicable): (EPOCH), extensible

Data type

text

Alias
UMLS CUI [1]
C2347803
SDTMIG 3.3
EPOCH
NCIt V19.10d
C71738
Start Date/Time of Element
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Start date/time for an Element for each subject. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C3812827
UMLS CUI [2,1]
C0805701
UMLS CUI [2,2]
C1301880
UMLS CUI [2,3]
C3812827
SDTMIG 3.3
SESTDTC
NCIt V19.10d
C83411
End Date/Time of Element
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): End date/time for an Element for each subject. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C3812827
UMLS CUI [2,1]
C0805701
UMLS CUI [2,2]
C1522314
UMLS CUI [2,3]
C3812827
SDTMIG 3.3
SEENDTC
NCIt V19.10d
C83410
Description of Unplanned Element
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): Description of what happened to the subject during an unplanned Element. Used only if ETCD has the value of "UNPLAN". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C3854240
UMLS CUI [1,4]
C3812827
SDTMIG 3.3
SEUPDES
NCIt V19.10d
C83412
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Similar models

Observation Class: Special Purpose - Domain: Subject Elements

59 forms
  1. StudyEvent: ODM
    1. Observation Class: Special Purpose - Domain: Comments
    2. Observation Class: Special Purpose - Domain: Demographics
    3. Observation Class: Special Purpose - Domain: Subject Elements
    4. Observation Class: Special Purpose - Domain: Subject Disease Milestones
    5. Observation Class: Special Purpose - Domain: Subject Visits
    6. Observation Class: Interventions - Domain: Procedure Agents
    7. Observation Class: Interventions - Domain: Concomitant/Prior Medications
    8. Observation Class: Interventions - Domain: Exposure
    9. Observation Class: Interventions - Domain: Exposure as Collected
    10. Observation Class: Interventions - Domain: Meal Data
    11. Observation Class: Interventions - Domain: Procedures
    12. Observation Class: Interventions - Domain: Substance Use
    13. Observation Class: Events - Domain: Adverse Events
    14. Observation Class: Events - Domain: Clinical Events
    15. Observation Class: Events - Domain: Disposition
    16. Observation Class: Events - Domain: Protocol Deviations
    17. Observation Class: Events - Domain: Healthcare Encounters
    18. Observation Class: Events - Domain: Medical History
    19. Observation Class: Findings - Domain: Drug Accountability
    20. Observation Class: Findings - Domain: Death Details
    21. Observation Class: Findings - Domain: ECG Test Results
    22. Observation Class: Findings - Domain: Inclusion/Exclusion Criteria Not Met
    23. Observation Class: Findings - Domain: Immunogenicity Specimen Assessments
    24. Observation Class: Findings - Domain: Laboratory Test Results
    25. Observation Class: Findings - Domain: Microbiology Specimen
    26. Observation Class: Findings - Domain: Microbiology Susceptibility
    27. Observation Class: Findings - Domain: Microscopic Findings
    28. Observation Class: Findings - Domain: Morphology
    29. Observation Class: Findings - Domain: Cardiovascular System Findings
    30. Observation Class: Findings - Domain: Musculoskeletal System Findings
    31. Observation Class: Findings - Domain: Nervous System Findings
    32. Observation Class: Findings - Domain: Ophthalmic Examinations
    33. Observation Class: Findings - Domain: Reproductive System Findings
    34. Observation Class: Findings - Domain: Respiratory System Findings
    35. Observation Class: Findings - Domain: Urinary System Findings
    36. Observation Class: Findings - Domain: Pharmacokinetics Concentrations
    37. Observation Class: Findings - Domain: Pharmacokinetics Parameters
    38. Observation Class: Findings - Domain: Physical Examination
    39. Observation Class: Findings - Domain: Functional Tests
    40. Observation Class: Findings - Domain: Questionnaires
    41. Observation Class: Findings - Domain: Disease Response and Clin Classification
    42. Observation Class: Findings - Domain: Subject Characteristics
    43. Observation Class: Findings - Domain: Subject Status
    44. Observation Class: Findings - Domain: Tumor/Lesion Identification
    45. Observation Class: Findings - Domain: Tumor/Lesion Results
    46. Observation Class: Findings - Domain: Vital Signs
    47. Observation Class: Findings - Domain: Findings About Events or Interventions
    48. Observation Class: Findings - Domain: Skin Response
    49. Observation Class: Trial Design - Domain: Trial Arms
    50. Observation Class: Trial Design - Domain: Trial Elements
    51. Observation Class: Trial Design - Domain: Trial Visits
    52. Observation Class: Trial Design - Domain: Trial Disease Assessments
    53. Observation Class: Trial Design - Domain: Trial Disease Milestones
    54. Observation Class: Trial Design - Domain: Trial Inclusion/Exclusion Criteria
    55. Observation Class: Trial Design - Domain: Trial Summary Information
    56. Observation Class: Relationships - Domain: Related Records
    57. Observation Class: Relationships - Domain: Supplemental Qualifiers for [domain name]
    58. Observation Class: Relationships - Domain: Related Subjects
    59. Observation Class: Study Reference - Domain: Non-host Organism Identifiers
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject Elements
SE (SDTMIG v3.3)
C1705189 (UMLS CUI-1)
C49616 (NCIt V19.10d:)
STUDYID
Item
Study Identifier
text
C2826693 (UMLS CUI [1])
STUDYID (SDTMIG 3.3)
C83082 (NCIt V19.10d)
DOMAIN
Item
Domain Abbreviation
text
C0000723 (UMLS CUI [1])
DOMAIN (SDTMIG 3.3)
C49556 (NCIt V19.10d)
USUBJID
Item
Unique Subject Identifier
text
C1710548 (UMLS CUI [1,1])
C2826693 (UMLS CUI [1,2])
USUBJID (SDTMIG 3.3)
C70731 (NCIt V19.10d)
SEQ
Item
Sequence Number
integer
C1705189 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
SESEQ (SDTMIG 3.3)
C87999 (NCIt V19.10d)
ETCD
Item
Element Code
text
C3812827 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
ETCD (SDTMIG 3.3)
C83275 (NCIt V19.10d)
ELEMENT
Item
Description of Element
text
C0678257 (UMLS CUI [1,1])
C3812827 (UMLS CUI [1,2])
ELEMENT (SDTMIG 3.3)
C105752 (NCIt V19.10d)
TAETORD
Item
Planned Order of Element within Arm
integer
C1301732 (UMLS CUI [1,1])
C3812827 (UMLS CUI [1,2])
C1705175 (UMLS CUI [1,3])
C1522541 (UMLS CUI [1,4])
TAETORD (SDTMIG 3.3)
C83438 (NCIt V19.10d)
Item
Epoch
text
C2347803 (UMLS CUI [1])
EPOCH (SDTMIG 3.3)
C71738 (NCIt V19.10d)
EPOCH
Code List
Epoch
CL Item
BASELINE (BASELINE)
C1552824 (UMLS CUI-1)
C125938 (NCIt V19.10d)
CL Item
BLINDED TREATMENT (BLINDED TREATMENT)
C3640651 (UMLS CUI-1)
C102255 (NCIt V19.10d)
CL Item
Continuation Phase (CONTINUATION TREATMENT)
C4055184 (UMLS CUI-1)
C123452 (NCIt V19.10d)
CL Item
FOLLOW-UP (FOLLOW-UP)
C3274571 (UMLS CUI-1)
C99158 (NCIt V19.10d)
CL Item
Induction Phase; Intensive Phase (INDUCTION TREATMENT)
C4049995 (UMLS CUI-1)
C123453 (NCIt V19.10d)
CL Item
LONG-TERM FOLLOW-UP (LONG-TERM FOLLOW-UP)
C1517942 (UMLS CUI-1)
C16032 (NCIt V19.10d)
CL Item
OPEN LABEL TREATMENT (OPEN LABEL TREATMENT)
C3640652 (UMLS CUI-1)
C102256 (NCIt V19.10d)
CL Item
RUN-IN (RUN-IN)
C3274438 (UMLS CUI-1)
C98779 (NCIt V19.10d)
CL Item
SCREENING (SCREENING)
C1710477 (UMLS CUI-1)
C48262 (NCIt V19.10d)
CL Item
TREATMENT (TREATMENT)
C3538994 (UMLS CUI-1)
C101526 (NCIt V19.10d)
CL Item
WASHOUT (WASHOUT)
C1710661 (UMLS CUI-1)
C42872 (NCIt V19.10d)
STDTC
Item
Start Date/Time of Element
datetime
C0805701 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C3812827 (UMLS CUI [1,3])
C0805701 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C3812827 (UMLS CUI [2,3])
SESTDTC (SDTMIG 3.3)
C83411 (NCIt V19.10d)
ENDTC
Item
End Date/Time of Element
datetime
C0805701 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C3812827 (UMLS CUI [1,3])
C0805701 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C3812827 (UMLS CUI [2,3])
SEENDTC (SDTMIG 3.3)
C83410 (NCIt V19.10d)
UPDES
Item
Description of Unplanned Element
text
C0805701 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
C3812827 (UMLS CUI [1,4])
SEUPDES (SDTMIG 3.3)
C83412 (NCIt V19.10d)
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