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Observation Class: Special Purpose - Domain: Subject Disease Milestones

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 Disease Milestones
Description

Subject Disease Milestones

Alias
SDTMIG v3.3
SM
UMLS CUI-1
C4553627
NCIt V19.10d:
C147184
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
Description

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

Data type

text

Alias
UMLS CUI [1]
C1883204
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. 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 to ensure uniqueness of subject records. Should be assigned to be consistent chronological order. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C4553627
UMLS CUI [1,2]
C2348184
SDTMIG 3.3
SMSEQ
NCIt V19.10d
C70710
NCIt V19.10d-2
C147184
Disease Milestone Instance Name
Description

Role: Topic CDISC Notes (for domains) Description (for General Classes): Name of the specific Disease Milestone. For types of Disease Milestone that can occur multiple times, the name will end with a sequence number. Example: "HYPO1". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C4553627
UMLS CUI [1,2]
C1550608
UMLS CUI [1,3]
C0027365
SDTMIG 3.3
MIDS
NCIt V19.10d
C162265
Disease Milestone Type
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): The type of Disease Milestone. Example: "HYPOGLYCEMIC EVENT". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C4553627
UMLS CUI [1,2]
C0332307
SDTMIG 3.3
MIDSTYPE
Start Date/Time of Milestone
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): State date/time of Milestone Instance, if Milestone is an intervention or event, or date of Milestone if Milestone is a finding. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C4553627
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C4553627
SDTMIG 3.3
SMSTDTC
NCIt V19.10d
C147184
NCIt V19.10d-2
C82517
End Date/Time of Milestone
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): End date/time of Disease Milestone Instance. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C4553627
UMLS CUI [2,1]
C1522314
UMLS CUI [2,2]
C4553627
SDTMIG 3.3
SMENDTC
NCIt V19.10d
C147184
NCIt V19.10d-2
C82516
Study Day of Start of Milestone
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of start of Disease Milestone Instance, relative to the sponsor-defined RFSTDTC. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C2826182
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C4553627
SDTMIG 3.3
SMSTDY
NCIt V19.10d
C82570
NCIt V19.10d-2
C147184
Study Day of End of Milestone
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of end of Disease Milestone Instance, relative to the sponsor-defined RFSTDTC. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C2826182
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C4553627
SDTMIG 3.3
SMENDY
NCIt V19.10d
C82569
NCIt V19.10d-2
C147184
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Similar models

Observation Class: Special Purpose - Domain: Subject Disease Milestones

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 Disease Milestones
SM (SDTMIG v3.3)
C4553627 (UMLS CUI-1)
C147184 (NCIt V19.10d:)
STUDYID
Item
Study Identifier
text
C2826693 (UMLS CUI [1])
STUDYID (SDTMIG 3.3)
C83082 (NCIt V19.10d)
DOMAIN
Item
Domain
text
C1883204 (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
C4553627 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
SMSEQ (SDTMIG 3.3)
C70710 (NCIt V19.10d)
C147184 (NCIt V19.10d-2)
MIDS
Item
Disease Milestone Instance Name
text
C4553627 (UMLS CUI [1,1])
C1550608 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,3])
MIDS (SDTMIG 3.3)
C162265 (NCIt V19.10d)
MIDSTYPE
Item
Disease Milestone Type
text
C4553627 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
MIDSTYPE (SDTMIG 3.3)
STDTC
Item
Start Date/Time of Milestone
datetime
C0808070 (UMLS CUI [1,1])
C4553627 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C4553627 (UMLS CUI [2,2])
SMSTDTC (SDTMIG 3.3)
C147184 (NCIt V19.10d)
C82517 (NCIt V19.10d-2)
ENDTC
Item
End Date/Time of Milestone
datetime
C0806020 (UMLS CUI [1,1])
C4553627 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C4553627 (UMLS CUI [2,2])
SMENDTC (SDTMIG 3.3)
C147184 (NCIt V19.10d)
C82516 (NCIt V19.10d-2)
STDY
Item
Study Day of Start of Milestone
text
C2826182 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C4553627 (UMLS CUI [1,3])
SMSTDY (SDTMIG 3.3)
C82570 (NCIt V19.10d)
C147184 (NCIt V19.10d-2)
ENDY
Item
Study Day of End of Milestone
text
C2826182 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C4553627 (UMLS CUI [1,3])
SMENDY (SDTMIG 3.3)
C82569 (NCIt V19.10d)
C147184 (NCIt V19.10d-2)
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