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Observation Class: Trial Design - Domain: Trial Disease Assessments

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 Disease Assessments
Description

Trial Disease Assessments

Alias
SDTMIG v3.3
TD
NCIt V19.10d:
C117699
UMLS CUI-1
C3889651
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): TD

Data type

text

Alias
UMLS CUI [1,1]
C1883204
UMLS CUI [1,2]
C0000723
SDTMIG 3.3
DOMAIN
NCIt V19.10d
C49556
Sequence of Planned Assessment Schedule
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): A number given to ensure ordinal sequencing of the planned assessment schedules within a trial. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C3889651
UMLS CUI [1,2]
C1519249
UMLS CUI [1,3]
C1301732
UMLS CUI [1,4]
C0392366
UMLS CUI [1,5]
C0086960
SDTMIG 3.3
TDORDER
NCIt V19.10d
C117700
Anchor Variable Name
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): A reference to the date variable name that provides the start point from which the planned disease assessment schedule is measured. This must be a referenced from the ADaM ADSL dataset, e.g. "ANCH1DT". Note: TDANCVAR will contain the name of a reference date variable. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C3889651
UMLS CUI [1,2]
C3900042
SDTMIG 3.3
TDANCVAR
NCIt V19.10d
C117701
Offset from the Anchor
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): A fixed offset from the date provided by the variable referenced in TDANCVAR. This is used when the timing of planned cycles does not start on the exact day referenced in the variable indicated in TDANCVAR. The value of this variable will be either zero or a positive value and will be represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C3889651
UMLS CUI [1,2]
C1711330
UMLS CUI [1,3]
C3854239
SDTMIG 3.3
TDSTOFF
NCIt V19.10d
C117702
Planned Assessment Interval
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): The planned interval between disease assessments represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C3889651
UMLS CUI [1,2]
C3897889
SDTMIG 3.3
TDTGTPAI
NCIt V19.10d
C117703
Planned Assessment Interval Minimum
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): The lower limit of the allowed range for the planned interval between disease assessments represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C3889651
UMLS CUI [1,2]
C3897889
UMLS CUI [1,3]
C1524031
SDTMIG 3.3
TDMINPAI
NCIt V19.10d
C117704
Planned Assessment Interval Maximum
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): The upper limit of the allowed range for the planned interval between disease assessments represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C3889651
UMLS CUI [1,2]
C3897889
UMLS CUI [1,3]
C0806909
SDTMIG 3.3
TDMAXPAI
NCIt V19.10d
C117705
Maximum Number of Actual Assessments
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): This variable must represent the maximum number of actual assessments for the analysis that this disease assessment schedule describes. In a trial where the maximum number of assessments is not defined explicitly in the protocol (e.g., assessments occur until death), TDNUMRPT should represent the maximum number of disease assessments that support the efficacy analysis encountered by any subject across the trial at that point in time. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C3889651
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0237753
SDTMIG 3.3
TDNUMRPT
NCIt V19.10d
C117706
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Similar models

Observation Class: Trial Design - Domain: Trial Disease Assessments

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 Disease Assessments
TD (SDTMIG v3.3)
C117699 (NCIt V19.10d:)
C3889651 (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)
ORDER
Item
Sequence of Planned Assessment Schedule
integer
C3889651 (UMLS CUI [1,1])
C1519249 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0392366 (UMLS CUI [1,4])
C0086960 (UMLS CUI [1,5])
TDORDER (SDTMIG 3.3)
C117700 (NCIt V19.10d)
ANCVAR
Item
Anchor Variable Name
text
C3889651 (UMLS CUI [1,1])
C3900042 (UMLS CUI [1,2])
TDANCVAR (SDTMIG 3.3)
C117701 (NCIt V19.10d)
STOFF
Item
Offset from the Anchor
durationDatetime
C3889651 (UMLS CUI [1,1])
C1711330 (UMLS CUI [1,2])
C3854239 (UMLS CUI [1,3])
TDSTOFF (SDTMIG 3.3)
C117702 (NCIt V19.10d)
TGTPAI
Item
Planned Assessment Interval
durationDatetime
C3889651 (UMLS CUI [1,1])
C3897889 (UMLS CUI [1,2])
TDTGTPAI (SDTMIG 3.3)
C117703 (NCIt V19.10d)
MINPAI
Item
Planned Assessment Interval Minimum
durationDatetime
C3889651 (UMLS CUI [1,1])
C3897889 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
TDMINPAI (SDTMIG 3.3)
C117704 (NCIt V19.10d)
MAXPAI
Item
Planned Assessment Interval Maximum
durationDatetime
C3889651 (UMLS CUI [1,1])
C3897889 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
TDMAXPAI (SDTMIG 3.3)
C117705 (NCIt V19.10d)
NUMRPT
Item
Maximum Number of Actual Assessments
integer
C3889651 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
TDNUMRPT (SDTMIG 3.3)
C117706 (NCIt V19.10d)
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