English

Observation Class: Findings - Domain: Subject Status

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
Subject Status
Description

Subject Status

Alias
SDTMIG v3.3
SS
NCIt V19.10d:
C117655
UMLS CUI-1
C0681850
UMLS CUI-2
C0449438
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): SS

Data type

text

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

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1710548
UMLS CUI [1,2]
C2826693
SDTMIG 3.3
USUBJID
NCIt V19.10d
C70731
Sequence Number
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C2348184
SDTMIG 3.3
SSSEQ
NCIt V19.10d
C117656
Group ID
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0441833
UMLS CUI [1,4]
C0600091
SDTMIG 3.3
SSGRPID
NCIt V19.10d
C117657
Sponsor-Defined Identifier
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number from the procedure or test page. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C2347796
UMLS CUI [1,4]
C0600091
SDTMIG 3.3
SSSPID
NCIt V19.10d
C117658
Status Short Name
Description

Role: Topic CDISC Notes (for domains) Description (for General Classes): Short name of the status assessment described in SSTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SSTESTCD cannot contain characters other than letters, numbers, or underscores. Example: "SURVSTAT". Controlled Terms or Format (if applicable): (SSTESTCD), extensible

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1806781
UMLS CUI [1,4]
C0027365
SDTMIG 3.3
SSTESTCD
NCIt V19.10d
C117659
Status Name
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): Verbatim name of the status assessment used to obtain the finding. The value in SSTEST cannot be longer than 40 characters. Example: "Survival Status". Controlled Terms or Format (if applicable): (SSTEST), extensible

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C2826273
SDTMIG 3.3
SSTEST
NCIt V19.10d
C117660
Category for Assessment
Description

Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): Used to categorize observations across subjects. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0683312
UMLS CUI [1,4]
C1516048
SDTMIG 3.3
SSCAT
NCIt V19.10d
C117661
Subcategory for Assessment
Description

Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): A further categorization. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C1515010
SDTMIG 3.3
SSSCAT
NCIt V19.10d
C117662
Result or Finding Original Result
Description

Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): Result of the status assessment finding as originally received or collected. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C0205313
SDTMIG 3.3
SSORRES
NCIt V19.10d
C117221
Character Result/Finding in Std Format
Description

Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): Contains the result value for all findings, copied or derived from SSORRES in a standard format. Controlled Terms or Format (if applicable): (SSTATRS), extensible

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C2350015
UMLS CUI [1,4]
C1274040
UMLS CUI [1,5]
C1442989
UMLS CUI [1,6]
C1301627
SDTMIG 3.3
SSSTRESC
NCIt V19.10d
C117664
Completion Status
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Used to indicate a status assessment was not done. Should be null if a result exists in SSORRES. Controlled Terms or Format (if applicable): (ND)

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0805732
SDTMIG 3.3
SSSTAT
NCIt V19.10d
C117665
Reason Assessment Not Performed
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Describes why an assessment was not performed. Example: "Subject Refused". Used in conjunction with SSSTAT when value is "NOT DONE". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C2826287
SDTMIG 3.3
SSREASND
NCIt V19.10d
C117666
Evaluator
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain collected or derived data. Examples: "CAREGIVER", "ADJUDICATION COMMITTEE", "FRIEND". Controlled Terms or Format (if applicable): (EVAL), extensible

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1707957
SDTMIG 3.3
SSEVAL
NCIt V19.10d
C117667
Visit Number
Description

Role: Timing 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: Timing 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. 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): Planned study day of the visit based upon RFSTDTC in Demographics. 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 Order of Element within Arm
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Number that gives the planned 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
Epoch
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Epoch associated with the start date/time of the subject status assessment. Controlled Terms or Format (if applicable): (EPOCH), extensible

Data type

text

Alias
UMLS CUI [1]
C2347803
SDTMIG 3.3
EPOCH
NCIt V19.10d
C71738
Date/Time of Assessment
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Date and time of the subject status assessment represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0681850
UMLS CUI [1,4]
C0449438
SDTMIG 3.3
SSDTC
NCIt V19.10d
C117668
Study Day of Assessment
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): 1. Study day of the test, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. Controlled Terms or Format (if applicable): NA

Data type

integer

Measurement units
  • d
Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C2826182
UMLS CUI [1,4]
C0392366
SDTMIG 3.3
SSDY
NCIt V19.10d
C117669
d
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Similar models

Observation Class: Findings - Domain: Subject Status

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
Subject Status
SS (SDTMIG v3.3)
C117655 (NCIt V19.10d:)
C0681850 (UMLS CUI-1)
C0449438 (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)
USUBJID
Item
Unique Subject Identifier
text
C1710548 (UMLS CUI [1,1])
C2826693 (UMLS CUI [1,2])
USUBJID (SDTMIG 3.3)
C70731 (NCIt V19.10d)
SEQ
Item
Sequence Number
integer
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
SSSEQ (SDTMIG 3.3)
C117656 (NCIt V19.10d)
GRPID
Item
Group ID
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
SSGRPID (SDTMIG 3.3)
C117657 (NCIt V19.10d)
SPID
Item
Sponsor-Defined Identifier
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
SSSPID (SDTMIG 3.3)
C117658 (NCIt V19.10d)
Item
Status Short Name
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1806781 (UMLS CUI [1,3])
C0027365 (UMLS CUI [1,4])
SSTESTCD (SDTMIG 3.3)
C117659 (NCIt V19.10d)
TESTCD
Code List
Status Short Name
CL Item
Survival Status (SURVSTAT)
C1148433 (UMLS CUI-1)
C25717 (NCIt V19.10d)
Item
Status Name
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C2826273 (UMLS CUI [1,3])
SSTEST (SDTMIG 3.3)
C117660 (NCIt V19.10d)
TEST
Code List
Status Name
CL Item
Survival Status (Survival Status)
C1148433 (UMLS CUI-1)
C25717 (NCIt V19.10d)
CAT
Item
Category for Assessment
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
SSCAT (SDTMIG 3.3)
C117661 (NCIt V19.10d)
SCAT
Item
Subcategory for Assessment
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C1515010 (UMLS CUI [1,4])
SSSCAT (SDTMIG 3.3)
C117662 (NCIt V19.10d)
ORRES
Item
Result or Finding Original Result
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205313 (UMLS CUI [1,4])
SSORRES (SDTMIG 3.3)
C117221 (NCIt V19.10d)
Item
Character Result/Finding in Std Format
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C1442989 (UMLS CUI [1,5])
C1301627 (UMLS CUI [1,6])
SSSTRESC (SDTMIG 3.3)
C117664 (NCIt V19.10d)
STRESC
Code List
Character Result/Finding in Std Format
CL Item
ALIVE (ALIVE)
C0376558 (UMLS CUI-1)
C37987 (NCIt V19.10d)
CL Item
Died (DEAD)
C0011065 (UMLS CUI-1)
C28554 (NCIt V19.10d)
CL Item
U; UNK; Unknown (UNKNOWN)
C0439673 (UMLS CUI-1)
C17998 (NCIt V19.10d)
STAT
Item
Completion Status
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0805732 (UMLS CUI [1,4])
SSSTAT (SDTMIG 3.3)
C117665 (NCIt V19.10d)
REASND
Item
Reason Assessment Not Performed
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C2826287 (UMLS CUI [1,4])
SSREASND (SDTMIG 3.3)
C117666 (NCIt V19.10d)
Item
Evaluator
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1707957 (UMLS CUI [1,3])
SSEVAL (SDTMIG 3.3)
C117667 (NCIt V19.10d)
EVALID
Code List
Evaluator
CL Item
ADJUDICATION COMMITTEE (ADJUDICATION COMMITTEE)
C2700368 (UMLS CUI-1)
C78726 (NCIt V19.10d)
CL Item
ADJUDICATOR (ADJUDICATOR)
C0401783 (UMLS CUI-1)
C96561 (NCIt V19.10d)
CL Item
Caregiver (CAREGIVER)
C0085537 (UMLS CUI-1)
C17445 (NCIt V19.10d)
CL Item
CHILD (CHILD)
C0680063 (UMLS CUI-1)
C42708 (NCIt V19.10d)
CL Item
Research Associate (CLINICAL RESEARCH ASSOCIATE)
C1516627 (UMLS CUI-1)
C25465 (NCIt V19.10d)
CL Item
CRC (CLINICAL RESEARCH COORDINATOR)
C1710220 (UMLS CUI-1)
C51811 (NCIt V19.10d)
CL Item
Clinical Study Sponsor; Sponsor; Study Sponsor (CLINICAL STUDY SPONSOR)
C2347796 (UMLS CUI-1)
C70793 (NCIt V19.10d)
CL Item
Domestic Partner (DOMESTIC PARTNER)
C1549111 (UMLS CUI-1)
C53262 (NCIt V19.10d)
CL Item
Family Member (FAMILY MEMBER)
C0086282 (UMLS CUI-1)
C41256 (NCIt V19.10d)
CL Item
FRIEND (FRIEND)
C0079382 (UMLS CUI-1)
C72884 (NCIt V19.10d)
CL Item
GUARDIAN (GUARDIAN)
C0023226 (UMLS CUI-1)
C51828 (NCIt V19.10d)
CL Item
HEALTH CARE PROFESSIONAL (HEALTH CARE PROFESSIONAL)
C1704312 (UMLS CUI-1)
C53287 (NCIt V19.10d)
CL Item
INDEPENDENT ASSESSOR (INDEPENDENT ASSESSOR)
C2697672 (UMLS CUI-1)
C78720 (NCIt V19.10d)
CL Item
INTERVIEWER (INTERVIEWER)
C0021821 (UMLS CUI-1)
C63759 (NCIt V19.10d)
CL Item
INVESTIGATOR (INVESTIGATOR)
C0035173 (UMLS CUI-1)
C25936 (NCIt V19.10d)
CL Item
PARENT (PARENT)
C0030551 (UMLS CUI-1)
C42709 (NCIt V19.10d)
CL Item
PROXY (PROXY)
C3897813 (UMLS CUI-1)
C119264 (NCIt V19.10d)
CL Item
SIBLING (SIBLING)
C0037047 (UMLS CUI-1)
C25204 (NCIt V19.10d)
CL Item
SIGNIFICANT OTHER (SIGNIFICANT OTHER)
C0682323 (UMLS CUI-1)
C119265 (NCIt V19.10d)
CL Item
Spouse (SPOUSE)
C0162409 (UMLS CUI-1)
C62649 (NCIt V19.10d)
CL Item
STUDY SUBJECT (STUDY SUBJECT)
C0681850 (UMLS CUI-1)
C41189 (NCIt V19.10d)
CL Item
VENDOR (VENDOR)
C0042462 (UMLS CUI-1)
C68608 (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)
TAETORD
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)
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)
DTC
Item
Date/Time of Assessment
datetime
C1264639 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0449438 (UMLS CUI [1,4])
SSDTC (SDTMIG 3.3)
C117668 (NCIt V19.10d)
DY
Item
Study Day of Assessment
integer
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,3])
C0392366 (UMLS CUI [1,4])
SSDY (SDTMIG 3.3)
C117669 (NCIt V19.10d)
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