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Observation Class: Trial Design - Domain: Trial 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
Trial Elements
Description

Trial Elements

Alias
SDTMIG v3.3
TE
NCIt V19.10d:
C49619
UMLS CUI-1
C1705540
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): TE

Data type

text

Alias
UMLS CUI [1,1]
C1705540
UMLS CUI [1,2]
C1883204
UMLS CUI [1,3]
C0000723
SDTMIG 3.3
DOMAIN
NCIt V19.10d
C49556
Element Code
Description

Role: Topic CDISC Notes (for domains) Description (for General Classes): 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. 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. 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
Rule for Start of Element
Description

Role: Rule CDISC Notes (for domains) Description (for General Classes): Expresses rule for beginning Element. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1705540
UMLS CUI [1,2]
C0870077
UMLS CUI [1,3]
C0439659
UMLS CUI [1,4]
C3812827
SDTMIG 3.3
TESTRL
NCIt V19.10d
C83442
Rule for End of Element
Description

Role: Rule CDISC Notes (for domains) Description (for General Classes): Expresses rule for ending Element. Either TEENRL or TEDUR must be present for each Element. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1705540
UMLS CUI [1,2]
C0870077
UMLS CUI [1,3]
C0444930
UMLS CUI [1,4]
C3812827
SDTMIG 3.3
TEENRL
NCIt V19.10d
C83441
Planned Duration of Element
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Planned Duration of Element in ISO 8601 format. Used when the rule for ending the Element is applied after a fixed duration. Controlled Terms or Format (if applicable): ISO 8601

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C1705540
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0449238
UMLS CUI [1,4]
C3812827
SDTMIG 3.3
TEDUR
NCIt V19.10d
C83440
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Similar models

Observation Class: Trial Design - Domain: Trial 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
Trial Elements
TE (SDTMIG v3.3)
C49619 (NCIt V19.10d:)
C1705540 (UMLS CUI-1)
STUDYID
Item
Study Identifier
text
C2826693 (UMLS CUI [1])
STUDYID (SDTMIG 3.3)
C83082 (NCIt V19.10d)
DOMAIN
Item
Domain Abbreviation
text
C1705540 (UMLS CUI [1,1])
C1883204 (UMLS CUI [1,2])
C0000723 (UMLS CUI [1,3])
DOMAIN (SDTMIG 3.3)
C49556 (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)
STRL
Item
Rule for Start of Element
text
C1705540 (UMLS CUI [1,1])
C0870077 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C3812827 (UMLS CUI [1,4])
TESTRL (SDTMIG 3.3)
C83442 (NCIt V19.10d)
ENRL
Item
Rule for End of Element
text
C1705540 (UMLS CUI [1,1])
C0870077 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C3812827 (UMLS CUI [1,4])
TEENRL (SDTMIG 3.3)
C83441 (NCIt V19.10d)
DUR
Item
Planned Duration of Element
durationDatetime
C1705540 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C3812827 (UMLS CUI [1,4])
TEDUR (SDTMIG 3.3)
C83440 (NCIt V19.10d)
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