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Observation Class: Trial Design - Domain: Trial Arms

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 Arms
Description

Trial Arms

Alias
SDTMIG v3.3
TA
NCIt V19.10d:
C49618
UMLS CUI-1
C1705538
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): TA

Data type

text

Alias
UMLS CUI [1,1]
C1705538
UMLS CUI [1,2]
C1883204
UMLS CUI [1,3]
C0000723
SDTMIG 3.3
DOMAIN
NCIt V19.10d
C49556
Planned Arm Code
Description

Role: Topic CDISC Notes (for domains) Description (for General Classes): ARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than that 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. 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): Name given to an Arm or treatment group. 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
Planned Order of Element within Arm
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Number that gives the order of the Element within the Arm. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C1705175
UMLS CUI [1,3]
C3812827
UMLS CUI [1,4]
C1522541
SDTMIG 3.3
TAETORD
NCIt V19.10d
C83438
Element Code
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C3812827
UMLS CUI [1,2]
C0805701
SDTMIG 3.3
ETCD
NCIt V19.10d
C83275
Description of Element
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): The name of the Element. The same Element may occur more than once within an Arm. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C3812827
SDTMIG 3.3
ELEMENT
NCIt V19.10d
C105752
Branch
Description

Role: Rule CDISC Notes (for domains) Description (for General Classes): Condition subject met, at a "branch" in the trial design at the end of this Element, to be included in this Arm (e.g., "Randomization to DRUG X"). Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1705538
UMLS CUI [1,2]
C0870077
SDTMIG 3.3
TABRANCH
NCIt V19.10d
C83437
Epoch
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Name of the Trial Epoch with which this Element of the Arm is associated. Controlled Terms or Format (if applicable): (EPOCH), extensible

Data type

text

Alias
UMLS CUI [1]
C2347803
SDTMIG 3.3
EPOCH
NCIt V19.10d
C71738
Transition Rule
Description

Role: Rule CDISC Notes (for domains) Description (for General Classes): If the trial design allows a subject to transition to an Element other than the next Element in sequence, then the conditions for transitioning to those other Elements, and the alternative Element sequences, are specified in this rule (e.g., "Responders go to washout"). Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1705538
UMLS CUI [1,2]
C2700061
UMLS CUI [1,3]
C0870077
SDTMIG 3.3
TATRANS
NCIt V19.10d
C83439
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Similar models

Observation Class: Trial Design - Domain: Trial Arms

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 Arms
TA (SDTMIG v3.3)
C49618 (NCIt V19.10d:)
C1705538 (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
C1705538 (UMLS CUI [1,1])
C1883204 (UMLS CUI [1,2])
C0000723 (UMLS CUI [1,3])
DOMAIN (SDTMIG 3.3)
C49556 (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)
ETORD
Item
Planned Order of Element within Arm
integer
C1301732 (UMLS CUI [1,1])
C1705175 (UMLS CUI [1,2])
C3812827 (UMLS CUI [1,3])
C1522541 (UMLS CUI [1,4])
TAETORD (SDTMIG 3.3)
C83438 (NCIt V19.10d)
ETCD
Item
Element Code
text
C3812827 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
ETCD (SDTMIG 3.3)
C83275 (NCIt V19.10d)
ELEMENT
Item
Description of Element
text
C0678257 (UMLS CUI [1,1])
C3812827 (UMLS CUI [1,2])
ELEMENT (SDTMIG 3.3)
C105752 (NCIt V19.10d)
BRANCH
Item
Branch
text
C1705538 (UMLS CUI [1,1])
C0870077 (UMLS CUI [1,2])
TABRANCH (SDTMIG 3.3)
C83437 (NCIt V19.10d)
Item
Epoch
text
C2347803 (UMLS CUI [1])
EPOCH (SDTMIG 3.3)
C71738 (NCIt V19.10d)
EPOCH
Code List
Epoch
CL Item
BASELINE (BASELINE)
C1552824 (UMLS CUI-1)
C125938 (NCIt V19.10d)
CL Item
BLINDED TREATMENT (BLINDED TREATMENT)
C3640651 (UMLS CUI-1)
C102255 (NCIt V19.10d)
CL Item
Continuation Phase (CONTINUATION TREATMENT)
C4055184 (UMLS CUI-1)
C123452 (NCIt V19.10d)
CL Item
FOLLOW-UP (FOLLOW-UP)
C3274571 (UMLS CUI-1)
C99158 (NCIt V19.10d)
CL Item
Induction Phase; Intensive Phase (INDUCTION TREATMENT)
C4049995 (UMLS CUI-1)
C123453 (NCIt V19.10d)
CL Item
LONG-TERM FOLLOW-UP (LONG-TERM FOLLOW-UP)
C1517942 (UMLS CUI-1)
C16032 (NCIt V19.10d)
CL Item
OPEN LABEL TREATMENT (OPEN LABEL TREATMENT)
C3640652 (UMLS CUI-1)
C102256 (NCIt V19.10d)
CL Item
RUN-IN (RUN-IN)
C3274438 (UMLS CUI-1)
C98779 (NCIt V19.10d)
CL Item
SCREENING (SCREENING)
C1710477 (UMLS CUI-1)
C48262 (NCIt V19.10d)
CL Item
TREATMENT (TREATMENT)
C3538994 (UMLS CUI-1)
C101526 (NCIt V19.10d)
CL Item
WASHOUT (WASHOUT)
C1710661 (UMLS CUI-1)
C42872 (NCIt V19.10d)
TRANS
Item
Transition Rule
text
C1705538 (UMLS CUI [1,1])
C2700061 (UMLS CUI [1,2])
C0870077 (UMLS CUI [1,3])
TATRANS (SDTMIG 3.3)
C83439 (NCIt V19.10d)
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