English

Observation Class: Trial Design - Domain: Trial Summary Information

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 Summary Information
Description

Trial Summary Information

Alias
SDTMIG v3.3
TS
NCIt V19.10d:
C53483
UMLS CUI-1
C0008976
UMLS CUI-2
C0242482
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): TS

Data type

text

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

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same TSPARMCD. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0242482
UMLS CUI [1,3]
C2348184
SDTMIG 3.3
TSSEQ
NCIt V19.10d
C83446
Group ID
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Used to tie together a group of related records. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0242482
UMLS CUI [1,3]
C0441833
UMLS CUI [1,4]
C0600091
SDTMIG 3.3
TSGRPID
NCIt V19.10d
C88007
Trial Summary Parameter Short Name
Description

Role: Topic CDISC Notes (for domains) Description (for General Classes): TSPARMCD (the companion to TSPARM) 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 TSPARMCD will need to serve as variable names. Examples: "AGEMIN", "AGEMAX". Controlled Terms or Format (if applicable): (TSPARMCD), extensible

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0242482
UMLS CUI [1,3]
C0549193
UMLS CUI [1,4]
C1806781
UMLS CUI [1,5]
C0027365
SDTMIG 3.3
TSPARMCD
NCIt V19.10d
C83445
Trial Summary Parameter
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): Term for the Trial Summary Parameter. The value in TSPARM cannot be longer than 40 characters. Examples: "Planned Minimum Age of Subjects", "Planned Maximum Age of Subjects". Controlled Terms or Format (if applicable): (TSPARM), extensible

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0242482
UMLS CUI [1,3]
C0549193
SDTMIG 3.3
TSPARM
NCIt V19.10d
C49691
Parameter Value
Description

Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): Value of TSPARM. Example: "ASTHMA" when TSPARM value is "Trial Indication". TSVAL can only be null when TSVALNF is populated. Text over 200 characters can be added to additional columns TSVAL1-TSVALn. See Assumption 8. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0242482
UMLS CUI [1,3]
C0549193
SDTMIG 3.3
TSVAL
NCIt V19.10d
C83447
Parameter Null Flavor
Description

Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): Null flavor for the value of TSPARM, to be populated if and only if TSVAL is null. Controlled Terms or Format (if applicable): ISO 21090 NullFlavor enumeration

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0242482
UMLS CUI [1,3]
C0549193
UMLS CUI [1,4]
C3897207
SDTMIG 3.3
TSVALNF
NCIt V19.10d
C117459
Parameter Value Code
Description

Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): This is the code of the term in TSVAL. For example, "6CW7F3G59X" is the code for Gabapentin; "C49488" is the code for Y. The length of this variable can be longer than 8 to accommodate the length of the external terminology. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0242482
UMLS CUI [1,3]
C0549193
UMLS CUI [1,4]
C0805701
SDTMIG 3.3
TSVALCD
NCIt V19.10d
C117458
Name of the Reference Terminology
Description

Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): The name of the Reference Terminology from which TSVALCD is taken. For example; CDISC, SNOMED, ISO 8601. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0242482
UMLS CUI [1,3]
C0027365
UMLS CUI [1,4]
C0034925
UMLS CUI [1,5]
C0028275
SDTMIG 3.3
TSVCDREF
NCIt V19.10d
C117460
Version of the Reference Terminology
Description

Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): The version number of the Reference Terminology, if applicable. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0242482
UMLS CUI [1,3]
C0333052
UMLS CUI [1,4]
C0034925
UMLS CUI [1,5]
C0028275
SDTMIG 3.3
TSVCDVER
NCIt V19.10d
C117461
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Similar models

Observation Class: Trial Design - Domain: Trial Summary Information

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 Summary Information
TS (SDTMIG v3.3)
C53483 (NCIt V19.10d:)
C0008976 (UMLS CUI-1)
C0242482 (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)
SEQ
Item
Sequence Number
integer
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
TSSEQ (SDTMIG 3.3)
C83446 (NCIt V19.10d)
GRPID
Item
Group ID
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
TSGRPID (SDTMIG 3.3)
C88007 (NCIt V19.10d)
Item
Trial Summary Parameter Short Name
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
C1806781 (UMLS CUI [1,4])
C0027365 (UMLS CUI [1,5])
TSPARMCD (SDTMIG 3.3)
C83445 (NCIt V19.10d)
PARMCD
Code List
Trial Summary Parameter Short Name
CL Item
Actual Number of Subjects (ACTSUB)
C3274372 (UMLS CUI-1)
C98703 (NCIt V19.10d)
CL Item
Adaptive Design (ADAPT)
C3274373 (UMLS CUI-1)
C146995 (NCIt V19.10d)
CL Item
Added on to Existing Treatments (ADDON)
C1710375 (UMLS CUI-1)
C49703 (NCIt V19.10d)
CL Item
Planned Maximum Age of Subjects (AGEMAX)
C1709559 (UMLS CUI-1)
C49694 (NCIt V19.10d)
CL Item
Planned Minimum Age of Subjects (AGEMIN)
C1709560 (UMLS CUI-1)
C49693 (NCIt V19.10d)
CL Item
Biospecimen Retention Contains DNA (BIOSPRET)
C4289919 (UMLS CUI-1)
C126058 (NCIt V19.10d)
CL Item
Blinded Status SDTM Dataset Generation; Blinded Status at SDTM Dataset Generation (BLNDSTAT)
C4528391 (UMLS CUI-1)
C139272 (NCIt V19.10d)
CL Item
Citation Used in Study (CITNSTDY)
C4289774 (UMLS CUI-1)
C127788 (NCIt V19.10d)
CL Item
Commercial Sponsor Status (CMSPSTAT)
C4288190 (UMLS CUI-1)
C127789 (NCIt V19.10d)
CL Item
Comparative Treatment Name (COMPTRT)
C2347178 (UMLS CUI-1)
C68612 (NCIt V19.10d)
CL Item
Confirmed Response Minimum Duration (CRMDUR)
C3274382 (UMLS CUI-1)
C98715 (NCIt V19.10d)
CL Item
Clinical Study Report Archive Date (CSRARDTC)
C4528392 (UMLS CUI-1)
C139273 (NCIt V19.10d)
CL Item
CDISC Therapeutic Area User Guide (CTAUG)
C4744931 (UMLS CUI-1)
C156602 (NCIt V19.10d)
CL Item
Current Therapy or Treatment (CURTRT)
C2827774 (UMLS CUI-1)
C85582 (NCIt V19.10d)
CL Item
Data Cutoff Description (DCUTDESC)
C3274385 (UMLS CUI-1)
C98718 (NCIt V19.10d)
CL Item
Data Cutoff Date (DCUTDTC)
C3274384 (UMLS CUI-1)
C98717 (NCIt V19.10d)
CL Item
Delayed Graft Function Diagnostic Criteria; Delayed Graft Function Dx Criteria (DGFCRIT)
C4525846 (UMLS CUI-1)
C135514 (NCIt V19.10d)
CL Item
Data Monitoring Committee Indicator (DMCIND)
C4289704 (UMLS CUI-1)
C127790 (NCIt V19.10d)
CL Item
Dose Level; Dose per Administration (DOSE)
C0178602 (UMLS CUI-1)
C25488 (NCIt V19.10d)
CL Item
Dose Form (DOSFRM)
C0013058 (UMLS CUI-1)
C42636 (NCIt V19.10d)
CL Item
Dosing Frequency (DOSFRQ)
C2982514 (UMLS CUI-1)
C89081 (NCIt V19.10d)
CL Item
Dose Regimen (DOSRGM)
C2348331 (UMLS CUI-1)
C71137 (NCIt V19.10d)
CL Item
Dose Units (DOSU)
C2348328 (UMLS CUI-1)
C73558 (NCIt V19.10d)
CL Item
Diagnostic Criteria (DXCRIT)
C0679228 (UMLS CUI-1)
C117960 (NCIt V19.10d)
CL Item
ECG Reading Blinded (EGBLIND)
C3899330 (UMLS CUI-1)
C119560 (NCIt V19.10d)
CL Item
ECG Continuous Monitoring (EGCTMON)
C3899331 (UMLS CUI-1)
C119561 (NCIt V19.10d)
CL Item
ECG Planned Primary Lead (EGLEADPR)
C3899329 (UMLS CUI-1)
C119562 (NCIt V19.10d)
CL Item
ECG Used Same Lead (EGLEADSM)
C3899319 (UMLS CUI-1)
C119563 (NCIt V19.10d)
CL Item
ECG Read Method (EGRDMETH)
C3899328 (UMLS CUI-1)
C119564 (NCIt V19.10d)
CL Item
ECG Replicates at Baseline (EGREPLBL)
C3899325 (UMLS CUI-1)
C119565 (NCIt V19.10d)
CL Item
ECG Replicates On-Treatment (EGREPLTR)
C3899326 (UMLS CUI-1)
C119566 (NCIt V19.10d)
CL Item
ECG Twave Algorithm (EGTWVALG)
C3899324 (UMLS CUI-1)
C119582 (NCIt V19.10d)
CL Item
Email Address for XML File (EMAILXML)
C4289662 (UMLS CUI-1)
C127791 (NCIt V19.10d)
CL Item
EMA Decision Number for PIP (EMPIPDCN)
C4289652 (UMLS CUI-1)
C126059 (NCIt V19.10d)
CL Item
EudraCT Resubmission Indicator (EURSBIND)
C4289562 (UMLS CUI-1)
C126060 (NCIt V19.10d)
CL Item
EudraVigilance Sender ID (EVSNDID)
C4289561 (UMLS CUI-1)
C126061 (NCIt V19.10d)
CL Item
EudraVigilance Sender Organization (EVSNDORG)
C4289560 (UMLS CUI-1)
C126090 (NCIt V19.10d)
CL Item
Expanded Access Record NCT Number (EXPARECN)
C4287891 (UMLS CUI-1)
C127792 (NCIt V19.10d)
CL Item
Expanded Access Status (EXPASTAT)
C4288105 (UMLS CUI-1)
C127793 (NCIt V19.10d)
CL Item
Extension Trial Indicator (EXTTIND)
C4528393 (UMLS CUI-1)
C139274 (NCIt V19.10d)
CL Item
Planned Country of Investigational Sites (FCNTRY)
C3274431 (UMLS CUI-1)
C98770 (NCIt V19.10d)
CL Item
FDA-Regulated Device Study Indicator (FDADEIND)
C4055026 (UMLS CUI-1)
C123629 (NCIt V19.10d)
CL Item
FDA-Regulated Drug Study Indicator (FDADRIND)
C4055025 (UMLS CUI-1)
C123630 (NCIt V19.10d)
CL Item
FDA Technical Specification (FDATCHSP)
C4744932 (UMLS CUI-1)
C156603 (NCIt V19.10d)
CL Item
Healthy Subject Indicator (HLTSUBJI)
C3274404 (UMLS CUI-1)
C98737 (NCIt V19.10d)
CL Item
Trial Disease/Condition Indication (INDIC)
C4316939 (UMLS CUI-1)
C112038 (NCIt V19.10d)
CL Item
Intervention Model (INTMODEL)
C3274411 (UMLS CUI-1)
C98746 (NCIt V19.10d)
CL Item
Intervention Type (INTTYPE)
C3274412 (UMLS CUI-1)
C98747 (NCIt V19.10d)
CL Item
Protocol Keyword (KEYWORD)
C4284778 (UMLS CUI-1)
C126062 (NCIt V19.10d)
CL Item
Trial Length (LENGTH)
C1706316 (UMLS CUI-1)
C49697 (NCIt V19.10d)
CL Item
Country of Manufacture (MNFCNTRY)
C4086226 (UMLS CUI-1)
C124455 (NCIt V19.10d)
CL Item
Multiple Site EU State Trial Indicator (MSEUTIND)
C4288708 (UMLS CUI-1)
C127794 (NCIt V19.10d)
CL Item
Planned Number of Arms (NARMS)
C3274432 (UMLS CUI-1)
C98771 (NCIt V19.10d)
CL Item
Number of Groups/Cohorts (NCOHORT)
C4288576 (UMLS CUI-1)
C126063 (NCIt V19.10d)
CL Item
Number of Trial Sites EU State (NUMSEUST)
C4288574 (UMLS CUI-1)
C127795 (NCIt V19.10d)
CL Item
Trial Exploratory Objective (OBJEXP)
C4552789 (UMLS CUI-1)
C4687738 (UMLS CUI-2)
C163559 (NCIt V19.10d)
CL Item
Trial Primary Objective (OBJPRIM)
C2827976 (UMLS CUI-1)
C85826 (NCIt V19.10d)
CL Item
Trial Secondary Objective (OBJSEC)
C2827977 (UMLS CUI-1)
C85827 (NCIt V19.10d)
CL Item
Observational Model (OBSMODEL)
C4288563 (UMLS CUI-1)
C126064 (NCIt V19.10d)
CL Item
Observational Time Perspective (OBSTIMP)
C4288560 (UMLS CUI-1)
C126065 (NCIt V19.10d)
CL Item
Obs Study Population Description (OBSTPOPD)
C4288562 (UMLS CUI-1)
C126066 (NCIt V19.10d)
CL Item
Observational Study Sampling Method (OBSTSMM)
C4284893 (UMLS CUI-1)
C126067 (NCIt V19.10d)
CL Item
Obs Study Sampling Method Description (OBSTSMMD)
C4288561 (UMLS CUI-1)
C126068 (NCIt V19.10d)
CL Item
Additional Outcome Measure (OUTMSADD)
C4744930 (UMLS CUI-1)
C156601 (NCIt V19.10d)
CL Item
Exploratory Outcome Measure (OUTMSEXP)
C3274391 (UMLS CUI-1)
C98724 (NCIt V19.10d)
CL Item
Primary Outcome Measure (OUTMSPRI)
C3274433 (UMLS CUI-1)
C98772 (NCIt V19.10d)
CL Item
Secondary Outcome Measure (OUTMSSEC)
C3274440 (UMLS CUI-1)
C98781 (NCIt V19.10d)
CL Item
Post Authorization Safety Study Ind (PASSIND)
C4528727 (UMLS CUI-1)
C139275 (NCIt V19.10d)
CL Item
Pharmacologic Class (PCLAS)
C3274429 (UMLS CUI-1)
C98768 (NCIt V19.10d)
CL Item
Pediatric Postmarket Study Indicator (PDPSTIND)
C4054220 (UMLS CUI-1)
C123631 (NCIt V19.10d)
CL Item
Pediatric Study Indicator (PDSTIND)
C4054218 (UMLS CUI-1)
C123632 (NCIt V19.10d)
CL Item
Pediatric Investigation Plan Indicator (PIPIND)
C4288416 (UMLS CUI-1)
C126069 (NCIt V19.10d)
CL Item
Anticipated Enrollment; Planned Enrollment; Planned Number of Subjects; Target Enrollment (PLANSUB)
C1709561 (UMLS CUI-1)
C49692 (NCIt V19.10d)
CL Item
Planned Trial Duration (PLNTRDUR)
C4288390 (UMLS CUI-1)
C127796 (NCIt V19.10d)
CL Item
Protocol Risk Assessment (PROTRSK)
C4528395 (UMLS CUI-1)
C139277 (NCIt V19.10d)
CL Item
Planned Treatment Duration (PTRTDUR)
C4528394 (UMLS CUI-1)
C139276 (NCIt V19.10d)
CL Item
PubMed ID for Citation Used in Study (PUBMEDID)
C4288349 (UMLS CUI-1)
C127797 (NCIt V19.10d)
CL Item
Trial is Randomized (RANDOM)
C0034656 (UMLS CUI-1)
C25196 (NCIt V19.10d)
CL Item
Randomization Quotient (RANDQT)
C3274436 (UMLS CUI-1)
C98775 (NCIt V19.10d)
CL Item
Rare Disease Indicator (RDIND)
C4288309 (UMLS CUI-1)
C126070 (NCIt V19.10d)
CL Item
Registry Identifier (REGID)
C3274381 (UMLS CUI-1)
C98714 (NCIt V19.10d)
CL Item
Resubmission Letter (RESUBLTR)
C4288288 (UMLS CUI-1)
C126071 (NCIt V19.10d)
CL Item
Relapse Criteria (RLPSCRIT)
C3897727 (UMLS CUI-1)
C117961 (NCIt V19.10d)
CL Item
Route of Administration (ROUTE)
C0013153 (UMLS CUI-1)
C38114 (NCIt V19.10d)
CL Item
Retained Biospecimen Description (RTSPCDES)
C4288287 (UMLS CUI-1)
C126072 (NCIt V19.10d)
CL Item
Request for XML Copy of Study Indicator (RXMLCIND)
C4288173 (UMLS CUI-1)
C127798 (NCIt V19.10d)
CL Item
Stable Disease Minimum Duration (SDMDUR)
C3274442 (UMLS CUI-1)
C98783 (NCIt V19.10d)
CL Item
SDTM IG Version; SDTM Implementation Guide Version (SDTIGVER)
C4744933 (UMLS CUI-1)
C156604 (NCIt V19.10d)
CL Item
SDTM Version (SDTMVER)
C4745323 (UMLS CUI-1)
C156605 (NCIt V19.10d)
CL Item
Secure Delivery XML Required Indicator (SDXMLIND)
C4288299 (UMLS CUI-1)
C127799 (NCIt V19.10d)
CL Item
Study End Date (SENDTC)
C2983670 (UMLS CUI-1)
C90462 (NCIt V19.10d)
CL Item
Severity Criteria (SEVCRIT)
C3897634 (UMLS CUI-1)
C117962 (NCIt V19.10d)
CL Item
Sex of Participants (SEXPOP)
C1710068 (UMLS CUI-1)
C49696 (NCIt V19.10d)
CL Item
Clinical Study Sponsor; Sponsor; Study Sponsor (SPONSOR)
C2347796 (UMLS CUI-1)
C70793 (NCIt V19.10d)
CL Item
SUSAR Reporting to EVCTM Indicator (SREVIND)
C4288259 (UMLS CUI-1)
C126073 (NCIt V19.10d)
CL Item
SUSAR Reporting to NCA Indicator (SRNCAIND)
C4288258 (UMLS CUI-1)
C126074 (NCIt V19.10d)
CL Item
Single Site EU State Trial Indicator (SSEUTIND)
C4288220 (UMLS CUI-1)
C127800 (NCIt V19.10d)
CL Item
Study Start Date (SSTDTC)
C2348558 (UMLS CUI-1)
C69208 (NCIt V19.10d)
CL Item
Substudy Details (SSTDYDTL)
C4288169 (UMLS CUI-1)
C126075 (NCIt V19.10d)
CL Item
Substudy Planned Indicator (SSTDYIND)
C4288168 (UMLS CUI-1)
C126076 (NCIt V19.10d)
CL Item
Study Stop Rules (STOPRULE)
C1710222 (UMLS CUI-1)
C49698 (NCIt V19.10d)
CL Item
Stratification Factor (STRATFCT)
C1514984 (UMLS CUI-1)
C16153 (NCIt V19.10d)
CL Item
Study Type (STYPE)
C0035171 (UMLS CUI-1)
C142175 (NCIt V19.10d)
CL Item
Trial Blinding Schema (TBLIND)
C1710473 (UMLS CUI-1)
C49658 (NCIt V19.10d)
CL Item
Control Type (TCNTRL)
C1707504 (UMLS CUI-1)
C49647 (NCIt V19.10d)
CL Item
Diagnosis Group (TDIGRP)
C1707731 (UMLS CUI-1)
C49650 (NCIt V19.10d)
CL Item
Therapeutic Area (THERAREA)
C3640078 (UMLS CUI-1)
C101302 (NCIt V19.10d)
CL Item
Trial Intent Type (TINDTP)
C1710474 (UMLS CUI-1)
C49652 (NCIt V19.10d)
CL Item
Trial Title (TITLE)
C1705824 (UMLS CUI-1)
C49802 (NCIt V19.10d)
CL Item
Trial Phase Classification (TPHASE)
C1710475 (UMLS CUI-1)
C48281 (NCIt V19.10d)
CL Item
Target Follow-Up Duration (TRGFUDUR)
C4288391 (UMLS CUI-1)
C126077 (NCIt V19.10d)
CL Item
Investigational Therapy or Treatment (TRT)
C1521826 (UMLS CUI-1)
C41161 (NCIt V19.10d)
CL Item
Trial Scope; Trial Type (TTYPE)
C0680731 (UMLS CUI-1)
C49660 (NCIt V19.10d)
CL Item
URL Related to Study (URLSTDY)
C4288174 (UMLS CUI-1)
C127801 (NCIt V19.10d)
CL Item
URL Related to Study Description (URLSTDYD)
C4288175 (UMLS CUI-1)
C127802 (NCIt V19.10d)
Item
Trial Summary Parameter
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
TSPARM (SDTMIG 3.3)
C49691 (NCIt V19.10d)
PARM
Code List
Trial Summary Parameter
CL Item
Actual Number of Subjects (Actual Number of Subjects)
C3274372 (UMLS CUI-1)
C98703 (NCIt V19.10d)
CL Item
Adaptive Design (Adaptive Design)
C3274373 (UMLS CUI-1)
C146995 (NCIt V19.10d)
CL Item
Added on to Existing Treatments (Added on to Existing Treatments)
C1710375 (UMLS CUI-1)
C49703 (NCIt V19.10d)
CL Item
Additional Outcome Measure (Additional Outcome Measure)
C4744930 (UMLS CUI-1)
C156601 (NCIt V19.10d)
CL Item
Biospecimen Retention Contains DNA (Biospecimen Retention Contains DNA)
C4289919 (UMLS CUI-1)
C126058 (NCIt V19.10d)
CL Item
Blinded Status SDTM Dataset Generation; Blinded Status at SDTM Dataset Generation (Blinded Status SDTM Dataset Generation)
C4528391 (UMLS CUI-1)
C139272 (NCIt V19.10d)
CL Item
CDISC Therapeutic Area User Guide (CDISC Therapeutic Area User Guide)
C4744931 (UMLS CUI-1)
C156602 (NCIt V19.10d)
CL Item
Citation Used in Study (Citation Used in Study)
C4289774 (UMLS CUI-1)
C127788 (NCIt V19.10d)
CL Item
Clinical Study Report Archive Date (Clinical Study Report Archive Date)
C4528392 (UMLS CUI-1)
C139273 (NCIt V19.10d)
CL Item
Clinical Study Sponsor; Sponsor; Study Sponsor (Clinical Study Sponsor)
C2347796 (UMLS CUI-1)
C70793 (NCIt V19.10d)
CL Item
Commercial Sponsor Status (Commercial Sponsor Status)
C4288190 (UMLS CUI-1)
C127789 (NCIt V19.10d)
CL Item
Comparative Treatment Name (Comparative Treatment Name)
C2347178 (UMLS CUI-1)
C68612 (NCIt V19.10d)
CL Item
Confirmed Response Minimum Duration (Confirmed Response Minimum Duration)
C3274382 (UMLS CUI-1)
C98715 (NCIt V19.10d)
CL Item
Control Type (Control Type)
C1707504 (UMLS CUI-1)
C49647 (NCIt V19.10d)
CL Item
Country of Manufacture (Country of Manufacture)
C4086226 (UMLS CUI-1)
C124455 (NCIt V19.10d)
CL Item
Current Therapy or Treatment (Current Therapy or Treatment)
C2827774 (UMLS CUI-1)
C85582 (NCIt V19.10d)
CL Item
Data Cutoff Date (Data Cutoff Date)
C3274384 (UMLS CUI-1)
C98717 (NCIt V19.10d)
CL Item
Data Cutoff Description (Data Cutoff Description)
C3274385 (UMLS CUI-1)
C98718 (NCIt V19.10d)
CL Item
Data Monitoring Committee Indicator (Data Monitoring Committee Indicator)
C4289704 (UMLS CUI-1)
C127790 (NCIt V19.10d)
CL Item
Delayed Graft Function Diagnostic Criteria; Delayed Graft Function Dx Criteria (Delayed Graft Function Dx Criteria)
C4525846 (UMLS CUI-1)
C135514 (NCIt V19.10d)
CL Item
Diagnosis Group (Diagnosis Group)
C1707731 (UMLS CUI-1)
C49650 (NCIt V19.10d)
CL Item
Diagnostic Criteria (Diagnostic Criteria)
C0679228 (UMLS CUI-1)
C117960 (NCIt V19.10d)
CL Item
Dose Form (Dose Form)
C0013058 (UMLS CUI-1)
C42636 (NCIt V19.10d)
CL Item
Dose Level; Dose per Administration (Dose per Administration)
C0178602 (UMLS CUI-1)
C25488 (NCIt V19.10d)
CL Item
Dose Regimen (Dose Regimen)
C2348331 (UMLS CUI-1)
C71137 (NCIt V19.10d)
CL Item
Dose Units (Dose Units)
C2348328 (UMLS CUI-1)
C73558 (NCIt V19.10d)
CL Item
Dosing Frequency (Dosing Frequency)
C2982514 (UMLS CUI-1)
C89081 (NCIt V19.10d)
CL Item
ECG Continuous Monitoring (ECG Continuous Monitoring)
C3899331 (UMLS CUI-1)
C119561 (NCIt V19.10d)
CL Item
ECG Planned Primary Lead (ECG Planned Primary Lead)
C3899329 (UMLS CUI-1)
C119562 (NCIt V19.10d)
CL Item
ECG Read Method (ECG Read Method)
C3899328 (UMLS CUI-1)
C119564 (NCIt V19.10d)
CL Item
ECG Reading Blinded (ECG Reading Blinded)
C3899330 (UMLS CUI-1)
C119560 (NCIt V19.10d)
CL Item
ECG Replicates at Baseline (ECG Replicates at Baseline)
C3899325 (UMLS CUI-1)
C119565 (NCIt V19.10d)
CL Item
ECG Replicates On-Treatment (ECG Replicates On-Treatment)
C3899326 (UMLS CUI-1)
C119566 (NCIt V19.10d)
CL Item
ECG Twave Algorithm (ECG Twave Algorithm)
C3899324 (UMLS CUI-1)
C119582 (NCIt V19.10d)
CL Item
ECG Used Same Lead (ECG Used Same Lead)
C3899319 (UMLS CUI-1)
C119563 (NCIt V19.10d)
CL Item
EMA Decision Number for PIP (EMA Decision Number for PIP)
C4289652 (UMLS CUI-1)
C126059 (NCIt V19.10d)
CL Item
Email Address for XML File (Email Address for XML File)
C4289662 (UMLS CUI-1)
C127791 (NCIt V19.10d)
CL Item
EudraCT Resubmission Indicator (EudraCT Resubmission Indicator)
C4289562 (UMLS CUI-1)
C126060 (NCIt V19.10d)
CL Item
EudraVigilance Sender ID (EudraVigilance Sender ID)
C4289561 (UMLS CUI-1)
C126061 (NCIt V19.10d)
CL Item
EudraVigilance Sender Organization (EudraVigilance Sender Organization)
C4289560 (UMLS CUI-1)
C126090 (NCIt V19.10d)
CL Item
Expanded Access Record NCT Number (Expanded Access Record NCT Number)
C4287891 (UMLS CUI-1)
C127792 (NCIt V19.10d)
CL Item
Expanded Access Status (Expanded Access Status)
C4288105 (UMLS CUI-1)
C127793 (NCIt V19.10d)
CL Item
Exploratory Outcome Measure (Exploratory Outcome Measure)
C3274391 (UMLS CUI-1)
C98724 (NCIt V19.10d)
CL Item
Extension Trial Indicator (Extension Trial Indicator)
C4528393 (UMLS CUI-1)
C139274 (NCIt V19.10d)
CL Item
FDA Technical Specification (FDA Technical Specification)
C4744932 (UMLS CUI-1)
C156603 (NCIt V19.10d)
CL Item
FDA-Regulated Device Study Indicator (FDA-Regulated Device Study Indicator)
C4055026 (UMLS CUI-1)
C123629 (NCIt V19.10d)
CL Item
FDA-Regulated Drug Study Indicator (FDA-Regulated Drug Study Indicator)
C4055025 (UMLS CUI-1)
C123630 (NCIt V19.10d)
CL Item
Healthy Subject Indicator (Healthy Subject Indicator)
C3274404 (UMLS CUI-1)
C98737 (NCIt V19.10d)
CL Item
Intervention Model (Intervention Model)
C3274411 (UMLS CUI-1)
C98746 (NCIt V19.10d)
CL Item
Intervention Type (Intervention Type)
C3274412 (UMLS CUI-1)
C98747 (NCIt V19.10d)
CL Item
Investigational Therapy or Treatment (Investigational Therapy or Treatment)
C1521826 (UMLS CUI-1)
C41161 (NCIt V19.10d)
CL Item
Multiple Site EU State Trial Indicator (Multiple Site EU State Trial Indicator)
C4288708 (UMLS CUI-1)
C127794 (NCIt V19.10d)
CL Item
Number of Groups/Cohorts (Number of Groups/Cohorts)
C4288576 (UMLS CUI-1)
C126063 (NCIt V19.10d)
CL Item
Number of Trial Sites EU State (Number of Trial Sites EU State)
C4288574 (UMLS CUI-1)
C127795 (NCIt V19.10d)
CL Item
Obs Study Population Description (Obs Study Population Description)
C4288562 (UMLS CUI-1)
C126066 (NCIt V19.10d)
CL Item
Obs Study Sampling Method Description (Obs Study Sampling Method Description)
C4288561 (UMLS CUI-1)
C126068 (NCIt V19.10d)
CL Item
Observational Model (Observational Model)
C4288563 (UMLS CUI-1)
C126064 (NCIt V19.10d)
CL Item
Observational Study Sampling Method (Observational Study Sampling Method)
C4284893 (UMLS CUI-1)
C126067 (NCIt V19.10d)
CL Item
Observational Time Perspective (Observational Time Perspective)
C4288560 (UMLS CUI-1)
C126065 (NCIt V19.10d)
CL Item
Pediatric Investigation Plan Indicator (Pediatric Investigation Plan Indicator)
C4288416 (UMLS CUI-1)
C126069 (NCIt V19.10d)
CL Item
Pediatric Postmarket Study Indicator (Pediatric Postmarket Study Indicator)
C4054220 (UMLS CUI-1)
C123631 (NCIt V19.10d)
CL Item
Pediatric Study Indicator (Pediatric Study Indicator)
C4054218 (UMLS CUI-1)
C123632 (NCIt V19.10d)
CL Item
Pharmacologic Class (Pharmacologic Class)
C3274429 (UMLS CUI-1)
C98768 (NCIt V19.10d)
CL Item
Planned Country of Investigational Sites (Planned Country of Investigational Sites)
C3274431 (UMLS CUI-1)
C98770 (NCIt V19.10d)
CL Item
Planned Maximum Age of Subjects (Planned Maximum Age of Subjects)
C1709559 (UMLS CUI-1)
C49694 (NCIt V19.10d)
CL Item
Planned Minimum Age of Subjects (Planned Minimum Age of Subjects)
C1709560 (UMLS CUI-1)
C49693 (NCIt V19.10d)
CL Item
Planned Number of Arms (Planned Number of Arms)
C3274432 (UMLS CUI-1)
C98771 (NCIt V19.10d)
CL Item
Anticipated Enrollment; Planned Enrollment; Planned Number of Subjects; Target Enrollment (Planned Number of Subjects)
C1709561 (UMLS CUI-1)
C49692 (NCIt V19.10d)
CL Item
Planned Treatment Duration (Planned Treatment Duration)
C4528394 (UMLS CUI-1)
C139276 (NCIt V19.10d)
CL Item
Planned Trial Duration (Planned Trial Duration)
C4288390 (UMLS CUI-1)
C127796 (NCIt V19.10d)
CL Item
Post Authorization Safety Study Ind (Post Authorization Safety Study Ind)
C4528727 (UMLS CUI-1)
C139275 (NCIt V19.10d)
CL Item
Primary Outcome Measure (Primary Outcome Measure)
C3274433 (UMLS CUI-1)
C98772 (NCIt V19.10d)
CL Item
Protocol Keyword (Protocol Keyword)
C4284778 (UMLS CUI-1)
C126062 (NCIt V19.10d)
CL Item
Protocol Risk Assessment (Protocol Risk Assessment)
C4528395 (UMLS CUI-1)
C139277 (NCIt V19.10d)
CL Item
PubMed ID for Citation Used in Study (PubMed ID for Citation Used in Study)
C4288349 (UMLS CUI-1)
C127797 (NCIt V19.10d)
CL Item
Randomization Quotient (Randomization Quotient)
C3274436 (UMLS CUI-1)
C98775 (NCIt V19.10d)
CL Item
Rare Disease Indicator (Rare Disease Indicator)
C4288309 (UMLS CUI-1)
C126070 (NCIt V19.10d)
CL Item
Registry Identifier (Registry Identifier)
C3274381 (UMLS CUI-1)
C98714 (NCIt V19.10d)
CL Item
Relapse Criteria (Relapse Criteria)
C3897727 (UMLS CUI-1)
C117961 (NCIt V19.10d)
CL Item
Request for XML Copy of Study Indicator (Request for XML Copy of Study Indicator)
C4288173 (UMLS CUI-1)
C127798 (NCIt V19.10d)
CL Item
Resubmission Letter (Resubmission Letter)
C4288288 (UMLS CUI-1)
C126071 (NCIt V19.10d)
CL Item
Retained Biospecimen Description (Retained Biospecimen Description)
C4288287 (UMLS CUI-1)
C126072 (NCIt V19.10d)
CL Item
Route of Administration (Route of Administration)
C0013153 (UMLS CUI-1)
C38114 (NCIt V19.10d)
CL Item
SDTM IG Version; SDTM Implementation Guide Version (SDTM IG Version)
C4744933 (UMLS CUI-1)
C156604 (NCIt V19.10d)
CL Item
SDTM Version (SDTM Version)
C4745323 (UMLS CUI-1)
C156605 (NCIt V19.10d)
CL Item
Secondary Outcome Measure (Secondary Outcome Measure)
C3274440 (UMLS CUI-1)
C98781 (NCIt V19.10d)
CL Item
Secure Delivery XML Required Indicator (Secure Delivery XML Required Indicator)
C4288299 (UMLS CUI-1)
C127799 (NCIt V19.10d)
CL Item
Severity Criteria (Severity Criteria)
C3897634 (UMLS CUI-1)
C117962 (NCIt V19.10d)
CL Item
Sex of Participants (Sex of Participants)
C1710068 (UMLS CUI-1)
C49696 (NCIt V19.10d)
CL Item
Single Site EU State Trial Indicator (Single Site EU State Trial Indicator)
C4288220 (UMLS CUI-1)
C127800 (NCIt V19.10d)
CL Item
Stable Disease Minimum Duration (Stable Disease Minimum Duration)
C3274442 (UMLS CUI-1)
C98783 (NCIt V19.10d)
CL Item
Stratification Factor (Stratification Factor)
C1514984 (UMLS CUI-1)
C16153 (NCIt V19.10d)
CL Item
Study End Date (Study End Date)
C2983670 (UMLS CUI-1)
C90462 (NCIt V19.10d)
CL Item
Study Start Date (Study Start Date)
C2348558 (UMLS CUI-1)
C69208 (NCIt V19.10d)
CL Item
Study Stop Rules (Study Stop Rules)
C1710222 (UMLS CUI-1)
C49698 (NCIt V19.10d)
CL Item
Study Type (Study Type)
C0035171 (UMLS CUI-1)
C142175 (NCIt V19.10d)
CL Item
Substudy Details (Substudy Details)
C4288169 (UMLS CUI-1)
C126075 (NCIt V19.10d)
CL Item
Substudy Planned Indicator (Substudy Planned Indicator)
C4288168 (UMLS CUI-1)
C126076 (NCIt V19.10d)
CL Item
SUSAR Reporting to EVCTM Indicator (SUSAR Reporting to EVCTM Indicator)
C4288259 (UMLS CUI-1)
C126073 (NCIt V19.10d)
CL Item
SUSAR Reporting to NCA Indicator (SUSAR Reporting to NCA Indicator)
C4288258 (UMLS CUI-1)
C126074 (NCIt V19.10d)
CL Item
Target Follow-Up Duration (Target Follow-Up Duration)
C4288391 (UMLS CUI-1)
C126077 (NCIt V19.10d)
CL Item
Therapeutic Area (Therapeutic Area)
C3640078 (UMLS CUI-1)
C101302 (NCIt V19.10d)
CL Item
Trial Blinding Schema (Trial Blinding Schema)
C1710473 (UMLS CUI-1)
C49658 (NCIt V19.10d)
CL Item
Trial Disease/Condition Indication (Trial Disease/Condition Indication)
C4316939 (UMLS CUI-1)
C112038 (NCIt V19.10d)
CL Item
Trial Exploratory Objective (Trial Exploratory Objective)
C4552789 (UMLS CUI-1)
C4687738 (UMLS CUI-2)
C163559 (NCIt V19.10d)
CL Item
Trial Intent Type (Trial Intent Type)
C1710474 (UMLS CUI-1)
C49652 (NCIt V19.10d)
CL Item
Trial is Randomized (Trial is Randomized)
C0034656 (UMLS CUI-1)
C25196 (NCIt V19.10d)
CL Item
Trial Length (Trial Length)
C1706316 (UMLS CUI-1)
C49697 (NCIt V19.10d)
CL Item
Trial Phase Classification (Trial Phase Classification)
C1710475 (UMLS CUI-1)
C48281 (NCIt V19.10d)
CL Item
Trial Primary Objective (Trial Primary Objective)
C2827976 (UMLS CUI-1)
C85826 (NCIt V19.10d)
CL Item
Trial Secondary Objective (Trial Secondary Objective)
C2827977 (UMLS CUI-1)
C85827 (NCIt V19.10d)
CL Item
Trial Title (Trial Title)
C1705824 (UMLS CUI-1)
C49802 (NCIt V19.10d)
CL Item
Trial Scope; Trial Type (Trial Type)
C0680731 (UMLS CUI-1)
C49660 (NCIt V19.10d)
CL Item
URL Related to Study (URL Related to Study)
C4288174 (UMLS CUI-1)
C127801 (NCIt V19.10d)
CL Item
URL Related to Study Description (URL Related to Study Description)
C4288175 (UMLS CUI-1)
C127802 (NCIt V19.10d)
VAL
Item
Parameter Value
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
TSVAL (SDTMIG 3.3)
C83447 (NCIt V19.10d)
Item
Parameter Null Flavor
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
C3897207 (UMLS CUI [1,4])
TSVALNF (SDTMIG 3.3)
C117459 (NCIt V19.10d)
VALNF
Code List
Parameter Null Flavor
CL Item
No information (NI)
C1546437 (UMLS CUI-1)
C53269 (NCIt V19.10d)
CL Item
Invalid (INV)
C1708563 (UMLS CUI-1)
C50913 (NCIt V19.10d)
CL Item
Invalid: Other (OTH)
C0205394 (UMLS CUI-1)
C17649 (NCIt V19.10d)
CL Item
Invalid: Other: Positive infinity (PINF)
C1550694 (UMLS CUI-1)
C80214 (NCIt V19.10d)
CL Item
Invalid: Other: Negative infinity (NINF)
C1550695 (UMLS CUI-1)
C80215 (NCIt V19.10d)
CL Item
Invalid: Unencoded (UNC)
C4724506 (UMLS CUI-1)
C150902 (NCIt V19.10d)
CL Item
Invalid: Derived (DER)
C1441547 (UMLS CUI-1)
C42885 (NCIt V19.10d)
CL Item
Unknown (UNK)
C0439673 (UMLS CUI-1)
C17998 (NCIt V19.10d)
CL Item
Asked but unknown (ASKU)
C1548672 (UMLS CUI-1)
C79729 (NCIt V19.10d)
CL Item
Asked but unknown: Temporarily unavailable (NAV)
C1549057 (UMLS CUI-1)
C150903 (NCIt V19.10d)
CL Item
Unknown: Not asked (NASK)
C1548670 (UMLS CUI-1)
C80217 (NCIt V19.10d)
CL Item
Unknown: Quantity sufficient (QS)
C1699029 (UMLS CUI-1)
C48590 (NCIt V19.10d)
CL Item
Unknown: Trace (TRC)
C1552622 (UMLS CUI-1)
C80218 (NCIt V19.10d)
CL Item
Masked (MSK)
C4724013 (UMLS CUI-1)
C150904 (NCIt V19.10d)
CL Item
Not applicable (NA)
C1272460 (UMLS CUI-1)
C48660 (NCIt V19.10d)
VALCD
Item
Parameter Value Code
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
TSVALCD (SDTMIG 3.3)
C117458 (NCIt V19.10d)
VCDREF
Item
Name of the Reference Terminology
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,3])
C0034925 (UMLS CUI [1,4])
C0028275 (UMLS CUI [1,5])
TSVCDREF (SDTMIG 3.3)
C117460 (NCIt V19.10d)
VCDVER
Item
Version of the Reference Terminology
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0333052 (UMLS CUI [1,3])
C0034925 (UMLS CUI [1,4])
C0028275 (UMLS CUI [1,5])
TSVCDVER (SDTMIG 3.3)
C117461 (NCIt V19.10d)
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