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

Trial Visits

Alias
SDTMIG v3.3
TV
NCIt V19.10d:
C49621
UMLS CUI-1
C1704705
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): TV

Data type

text

Alias
UMLS CUI [1,1]
C1883204
UMLS CUI [1,2]
C0000723
SDTMIG 3.3
DOMAIN
NCIt V19.10d
C49556
Visit Number
Description

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

Data type

integer

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): 1. Planned study day of VISIT. 2. Due to its sequential nature, used for sorting. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C2826182
UMLS CUI [1,3]
C0545082
SDTMIG 3.3
VISITDY
NCIt V19.10d
C83450
Planned Arm Code
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): 1. ARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than for other "short" variables to accommodate the kind of values that are likely to be needed for crossover trials. For example, if ARMCD values for a seven-period crossover were constructed using two-character abbreviations for each treatment and separating hyphens, the length of ARMCD values would be 20. 2. If the timing of Visits for a trial does not depend on which Arm a subject is in, then ARMCD should be null. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C1522541
UMLS CUI [1,3]
C0805701
SDTMIG 3.3
ARMCD
NCIt V19.10d
C83216
Description of Planned Arm
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): 1. Name given to an Arm or Treatment Group. 2. If the timing of Visits for a trial does not depend on which Arm a subject is in, then Arm should be left blank. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C1522541
SDTMIG 3.3
ARM
NCIt V19.10d
C83216
Visit Start Rule
Description

Role: Rule CDISC Notes (for domains) Description (for General Classes): Rule describing when the Visit starts, in relation to the sequence of Elements. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1704705
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0439659
UMLS CUI [1,4]
C0870077
SDTMIG 3.3
TVSTRL
NCIt V19.10d
C83449
Visit End Rule
Description

Role: Rule CDISC Notes (for domains) Description (for General Classes): Rule describing when the Visit ends, in relation to the sequence of Elements. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1704705
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0444930
UMLS CUI [1,4]
C0870077
SDTMIG 3.3
TVENRL
NCIt V19.10d
C83448
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Similar models

Observation Class: Trial Design - Domain: Trial 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
Trial Visits
TV (SDTMIG v3.3)
C49621 (NCIt V19.10d:)
C1704705 (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
C1883204 (UMLS CUI [1,1])
C0000723 (UMLS CUI [1,2])
DOMAIN (SDTMIG 3.3)
C49556 (NCIt V19.10d)
VISITNUM
Item
Visit Number
integer
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
integer
C1301732 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
VISITDY (SDTMIG 3.3)
C83450 (NCIt V19.10d)
ARMCD
Item
Planned Arm Code
text
C1301732 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
ARMCD (SDTMIG 3.3)
C83216 (NCIt V19.10d)
ARM
Item
Description of Planned Arm
text
C0678257 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,3])
ARM (SDTMIG 3.3)
C83216 (NCIt V19.10d)
STRL
Item
Visit Start Rule
text
C1704705 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0870077 (UMLS CUI [1,4])
TVSTRL (SDTMIG 3.3)
C83449 (NCIt V19.10d)
ENRL
Item
Visit End Rule
text
C1704705 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0870077 (UMLS CUI [1,4])
TVENRL (SDTMIG 3.3)
C83448 (NCIt V19.10d)
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