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Observation Class: Trial Design - Domain: Trial Inclusion/Exclusion Criteria

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 Inclusion/Exclusion Criteria
Description

Trial Inclusion/Exclusion Criteria

Alias
SDTMIG v3.3
TI
NCIt V19.10d:
C49620
UMLS CUI-1
C1512693
UMLS CUI-2
C0680251
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): TI

Data type

text

Alias
UMLS CUI [1,1]
C1883204
UMLS CUI [1,2]
C0000723
SDTMIG 3.3
DOMAIN
NCIt V19.10d
C49556
Incl/Excl Criterion Short Name
Description

Role: Topic CDISC Notes (for domains) Description (for General Classes): Short name IETEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in IETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). IETESTCD cannot contain characters other than letters, numbers, or underscores. The prefix "IE" is used to ensure consistency with the IE domain. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1806781
UMLS CUI [1,3]
C0027365
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C1806781
UMLS CUI [2,3]
C0027365
SDTMIG 3.3
IETESTCD
NCIt V19.10d
C83144
Inclusion/Exclusion Criterion
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): Full text of the inclusion or exclusion criterion. The prefix "IE" is used to ensure consistency with the IE domain. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0392366
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0392366
SDTMIG 3.3
IETEST
NCIt V19.10d
C83147
Inclusion/Exclusion Category
Description

Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): Used for categorization of the inclusion or exclusion criteria. Controlled Terms or Format (if applicable): (IECAT), not extensible

Data type

text

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0683312
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0683312
SDTMIG 3.3
IECAT
NCIt V19.10d
C83016
Inclusion/Exclusion Subcategory
Description

Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): A further categorization of the exception criterion. Can be used to distinguish criteria for a sub-study or to categorize as major or minor exceptions. Examples: "MAJOR", "MINOR". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1515010
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C1515010
SDTMIG 3.3
IESCAT
NCIt V19.10d
C83298
Inclusion/Exclusion Criterion Rule
Description

Role: Rule CDISC Notes (for domains) Description (for General Classes): Rule that expresses the criterion in computer-executable form. See Assumption 4. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0870077
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0870077
SDTMIG 3.3
TIRL
NCIt V19.10d
C83443
Protocol Criteria Versions
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): The number of this version of the Inclusion/Exclusion criteria. May be omitted if there is only one version. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0333052
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0333052
SDTMIG 3.3
TIVERS
NCIt V19.10d
C83444
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Similar models

Observation Class: Trial Design - Domain: Trial Inclusion/Exclusion Criteria

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 Inclusion/Exclusion Criteria
TI (SDTMIG v3.3)
C49620 (NCIt V19.10d:)
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
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)
IETESTCD
Item
Incl/Excl Criterion Short Name
text
C1512693 (UMLS CUI [1,1])
C1806781 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2,1])
C1806781 (UMLS CUI [2,2])
C0027365 (UMLS CUI [2,3])
IETESTCD (SDTMIG 3.3)
C83144 (NCIt V19.10d)
IETEST
Item
Inclusion/Exclusion Criterion
text
C1512693 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C0392366 (UMLS CUI [2,2])
IETEST (SDTMIG 3.3)
C83147 (NCIt V19.10d)
Item
Inclusion/Exclusion Category
text
C1512693 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C0683312 (UMLS CUI [2,2])
IECAT (SDTMIG 3.3)
C83016 (NCIt V19.10d)
IECAT
Code List
Inclusion/Exclusion Category
CL Item
EXCLUSION (EXCLUSION)
C0680251 (UMLS CUI-1)
C25370 (NCIt V19.10d)
CL Item
INCLUSION (INCLUSION)
C1512693 (UMLS CUI-1)
C25532 (NCIt V19.10d)
IESCAT
Item
Inclusion/Exclusion Subcategory
text
C1512693 (UMLS CUI [1,1])
C1515010 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C1515010 (UMLS CUI [2,2])
IESCAT (SDTMIG 3.3)
C83298 (NCIt V19.10d)
RL
Item
Inclusion/Exclusion Criterion Rule
text
C1512693 (UMLS CUI [1,1])
C0870077 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C0870077 (UMLS CUI [2,2])
TIRL (SDTMIG 3.3)
C83443 (NCIt V19.10d)
VERS
Item
Protocol Criteria Versions
integer
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0333052 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0333052 (UMLS CUI [2,3])
TIVERS (SDTMIG 3.3)
C83444 (NCIt V19.10d)
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