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Observation Class: Special Purpose - Domain: Subject Visits

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 Visits
Description

Subject Visits

Alias
SDTMIG v3.3
SV
UMLS CUI-1
C1704677
NCIt V19.10d:
C49617
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): SV

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
Visit Number
Description

Role: Topic CDISC Notes (for domains) Description (for General Classes): 1. Clinical encounter number. (Decimal numbering may be useful for inserting unplanned visits.) 2. Numeric version of VISIT, used for sorting. Controlled Terms or Format (if applicable): NA

Data type

float

Alias
UMLS CUI [1]
C1549755
SDTMIG 3.3
VISITNUM
NCIt V19.10d
C83101
Visit Name
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY as a text description of the clinical encounter. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1]
C2826704
SDTMIG 3.3
VISIT
NCIt V19.10d
C83093
Planned Study Day of Visit
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Planned study day of the start of the visit based upon RFSTDTC in Demographics. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C2826182
SDTMIG 3.3
VISITDY
NCIt V19.10d
C83450
Start Date/Time of Visit
Description

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

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0545082
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C0545082
SDTMIG 3.3
SVSTDTC
NCIt V19.10d
C83436
End Date/Time of Visit
Description

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

Data type

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0545082
UMLS CUI [2,1]
C1522314
UMLS CUI [2,2]
C0545082
SDTMIG 3.3
SVENDTC
NCIt V19.10d
C83435
Study Day of Start of Visit
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0439659
UMLS CUI [1,2]
C2826182
SDTMIG 3.3
SVSTDY
NCIt V19.10d
C88001
Study Day of End of Visit
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0444930
UMLS CUI [1,2]
C2826182
SDTMIG 3.3
SVENDY
NCIt V19.10d
C88000
Description of Unplanned Visit
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): Description of what happened to the subject during an unplanned visit. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C3854240
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0678257
SDTMIG 3.3
SVUPDES
NCIt V19.10d
C88009
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Similar models

Observation Class: Special Purpose - Domain: Subject Visits

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 Visits
SV (SDTMIG v3.3)
C1704677 (UMLS CUI-1)
C49617 (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)
VISITNUM
Item
Visit Number
float
C1549755 (UMLS CUI [1])
VISITNUM (SDTMIG 3.3)
C83101 (NCIt V19.10d)
VISIT
Item
Visit Name
text
C2826704 (UMLS CUI [1])
VISIT (SDTMIG 3.3)
C83093 (NCIt V19.10d)
VISITDY
Item
Planned Study Day of Visit
text
C1301732 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
VISITDY (SDTMIG 3.3)
C83450 (NCIt V19.10d)
STDTC
Item
Start Date/Time of Visit
datetime
C0808070 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
SVSTDTC (SDTMIG 3.3)
C83436 (NCIt V19.10d)
ENDTC
Item
End Date/Time of Visit
datetime
C0806020 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
SVENDTC (SDTMIG 3.3)
C83435 (NCIt V19.10d)
STDY
Item
Study Day of Start of Visit
text
C0439659 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
SVSTDY (SDTMIG 3.3)
C88001 (NCIt V19.10d)
ENDY
Item
Study Day of End of Visit
text
C0444930 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
SVENDY (SDTMIG 3.3)
C88000 (NCIt V19.10d)
UPDES
Item
Description of Unplanned Visit
text
C0545082 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
SVUPDES (SDTMIG 3.3)
C88009 (NCIt V19.10d)
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