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Observation Class: Special Purpose - Domain: Comments

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
Comments
Description

Comments

Alias
SDTMIG v3.3
CO
NCIt V19.10d:
C49569
UMLS CUI-1
C1705247
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): CO

Data type

text

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

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain of the parent record(s). Null for comments collected on a general comments or additional information CRF page. Controlled Terms or Format (if applicable): NA, extensible

Data type

text

Alias
UMLS CUI [1,1]
C1883204
UMLS CUI [1,2]
C0000723
SDTMIG 3.3
RDOMAIN
NCIt V19.10d
C83391
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

text

Alias
UMLS CUI [1]
C2348184
SDTMIG 3.3
COSEQ
NCIt V19.10d
C83240
Identifying Variable
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Identifying variable in the parent dataset that identifies the record(s) to which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments are related to domain records. Null for comments collected on separate CRFs. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0439828
SDTMIG 3.3
IDVAR
NCIt V19.10d
C83293
Identifying Variable Value
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Value of identifying variable of the parent record(s). Used only when individual comments are related to domain records. Null for comments collected on separate CRFs. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0439828
SDTMIG 3.3
IDVARVAL
NCIt V19.10d
C83294
Comment Reference
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Sponsor-defined reference associated with the comment. May be the CRF page number (e.g., 650), or a module name (e.g., DEMOG), or a combination of information that identifies the reference (e.g. 650-VITALS-VISIT 2). Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1706462
SDTMIG 3.3
COREF
NCIt V19.10d
C82504
Comment
Description

Role: Topic CDISC Notes (for domains) Description (for General Classes): The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn. See Assumption 3. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1]
C0947611
SDTMIG 3.3
COVAL
NCIt V19.10d
C83241
Evaluator
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Used to describe the originator of the comment. Examples: CENTRAL, REVIEWER, ADJUDICATION COMMITTEE, PRINCIPAL INVESTIGATOR. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1707957
SDTMIG 3.3
COEVAL
NCIt V19.10d
C83239
Evaluator Identifier
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Used to distinguish multiple evaluators with the same role recorded in --EVAL. Examples: RADIOLOGIST, RADIOLOGIST1, RADIOLOGIST2. Controlled Terms or Format (if applicable): (MEDEVAL), extensible

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1707957
UMLS CUI [1,3]
C0600091
SDTMIG 3.3
COEVALID
NCIt V19.10d
C117043
NCIt V19.10d-2
C49569
Date/Time of Comment
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Date/time of comment on dedicated comment form. Should be null if this is a child record of another domain or if comment date was not collected. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0947611
SDTMIG 3.3
CODTC
NCIt V19.10d
C83238
Study Day of Comment
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of the comment, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. Controlled Terms or Format (if applicable): NA

Data type

integer

Measurement units
  • d
Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2826182
SDTMIG 3.3
CODY
NCIt V19.10d
C119819
d
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Similar models

Observation Class: Special Purpose - Domain: Comments

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
Comments
CO (SDTMIG v3.3)
C49569 (NCIt V19.10d:)
C1705247 (UMLS CUI-1)
STUDYID
Item
Study Identifier
text
C2826693 (UMLS CUI [1])
STUDYID (SDTMIG 3.3)
C83082 (NCIt V19.10d)
DOMAIN
Item
Domain Abbreviation
text
C1883204 (UMLS CUI [1,1])
C0000723 (UMLS CUI [1,2])
DOMAIN (SDTMIG 3.3)
C49556 (NCIt V19.10d)
Item
Related Domain Abbreviation
text
C1883204 (UMLS CUI [1,1])
C0000723 (UMLS CUI [1,2])
RDOMAIN (SDTMIG 3.3)
C83391 (NCIt V19.10d)
RDOMAIN
Code List
Related Domain Abbreviation
CL Item
Analysis Dataset (AD)
ADaM (Comment:en)
C1704642 (UMLS CUI-1)
C49563 (NCIt V19.10d)
CL Item
Adverse Events (AE)
C1705413 (UMLS CUI-1)
C49562 (NCIt V19.10d)
CL Item
Procedure Agents (AG)
C3888235 (UMLS CUI-1)
C117755 (NCIt V19.10d)
CL Item
Associated Persons Adverse Events (APAE)
SDTMIG-AP (Comment:en)
C4688600 (UMLS CUI-1)
C147168 (NCIt V19.10d)
CL Item
Associated Persons Biospecimen (APBS)
SDTMIG-AP (Comment:en)
C4687757 (UMLS CUI-1)
C147169 (NCIt V19.10d)
CL Item
Associated Persons Death Details (APDD)
SDTMIG-AP (Comment:en)
C4687758 (UMLS CUI-1)
C147170 (NCIt V19.10d)
CL Item
Associated Persons Demographics (APDM)
SDTMIG-AP (Comment:en)
C4329363 (UMLS CUI-1)
C132354 (NCIt V19.10d)
CL Item
Associated Persons Exposure (APEX)
SDTMIG-AP (Comment:en)
C4553046 (UMLS CUI-1)
C147171 (NCIt V19.10d)
CL Item
Associated Persons Laboratory Test Results (APLB)
SDTMIG-AP (Comment:en)
C4687759 (UMLS CUI-1)
C147172 (NCIt V19.10d)
CL Item
Associated Persons Medical History (APMH)
SDTMIG-AP (Comment:en)
C4687760 (UMLS CUI-1)
C147173 (NCIt V19.10d)
CL Item
Associated Persons Questionnaires (APQS)
SDTMIG-AP (Comment:en)
C4687761 (UMLS CUI-1)
C147174 (NCIt V19.10d)
CL Item
Relationship between Associated Persons and Subjects (APRELSUB)
SDTMIG-AP (Comment:en)
C4687762 (UMLS CUI-1)
C147175 (NCIt V19.10d)
CL Item
Associated Persons Reproductive System Findings (APRP)
SDTMIG-AP (Comment:en)
C4687763 (UMLS CUI-1)
C147176 (NCIt V19.10d)
CL Item
Associated Persons Subject Characteristics (APSC)
SDTMIG-AP (Comment:en)
C4553017 (UMLS CUI-1)
C147177 (NCIt V19.10d)
CL Item
Associated Persons Subject Status (APSS)
SDTMIG-AP (Comment:en)
C4553488 (UMLS CUI-1)
C147178 (NCIt V19.10d)
CL Item
Associated Persons Substance Use (APSU)
SDTMIG-AP (Comment:en)
C4687764 (UMLS CUI-1)
C147179 (NCIt V19.10d)
CL Item
Non-Compliant ADaM Dataset (AX)
ADaM (Comment:en)
C3714936 (UMLS CUI-1)
C111282 (NCIt V19.10d)
CL Item
Biospecimen Events (BE)
SDTMIG-PGx (Comment:en)
C3811654 (UMLS CUI-1)
C111138 (NCIt V19.10d)
CL Item
Biospecimen Findings (BS)
SDTMIG-PGx (Comment:en)
C3814390 (UMLS CUI-1)
C111137 (NCIt V19.10d)
CL Item
Clinical Events (CE)
C2827664 (UMLS CUI-1)
C85441 (NCIt V19.10d)
CL Item
Concomitant/Prior Medications (CM)
C1704627 (UMLS CUI-1)
C49568 (NCIt V19.10d)
CL Item
Comments (CO)
C1705247 (UMLS CUI-1)
C49569 (NCIt V19.10d)
CL Item
Cardiovascular System Findings (CV)
C3538987 (UMLS CUI-1)
C102605 (NCIt V19.10d)
CL Item
Drug Accountability (DA)
C1704643 (UMLS CUI-1)
C49578 (NCIt V19.10d)
CL Item
Death Details; Death Diagnosis and Details (DD)
C2986893 (UMLS CUI-1)
C95087 (NCIt V19.10d)
CL Item
Device Events (DE)
SDTMIG-MD (Comment:en)
C3541240 (UMLS CUI-1)
C102616 (NCIt V19.10d)
CL Item
Device Identifiers (DI)
SDTMIG-MD (Comment:en)
C3541881 (UMLS CUI-1)
C102618 (NCIt V19.10d)
CL Item
Demographics (DM)
C1704791 (UMLS CUI-1)
C49572 (NCIt V19.10d)
CL Item
Device Properties (DO)
SDTMIG-MD (Comment:en)
C3539061 (UMLS CUI-1)
C102619 (NCIt V19.10d)
CL Item
Device-Subject Relationships (DR)
SDTMIG-MD (Comment:en)
C3540849 (UMLS CUI-1)
C102620 (NCIt V19.10d)
CL Item
Disposition (DS)
C1705555 (UMLS CUI-1)
C49576 (NCIt V19.10d)
CL Item
Device Tracking and Disposition (DT)
SDTMIG-MD (Comment:en)
C3542920 (UMLS CUI-1)
C102621 (NCIt V19.10d)
CL Item
Device In-Use (DU)
SDTMIG-MD (Comment:en)
C3540681 (UMLS CUI-1)
C102622 (NCIt V19.10d)
CL Item
Protocol Deviations (DV)
C1704645 (UMLS CUI-1)
C49585 (NCIt V19.10d)
CL Item
Device Exposure (DX)
SDTMIG-MD (Comment:en)
C3538936 (UMLS CUI-1)
C102617 (NCIt V19.10d)
CL Item
Exposure as Collected (EC)
C3890233 (UMLS CUI-1)
C117466 (NCIt V19.10d)
CL Item
Endocrine System Findings (ED)
not defined in SDTMIG v3.3 (Comment:en)
C3538926 (UMLS CUI-1)
C102630 (NCIt V19.10d)
CL Item
ECG Test Results (EG)
C1705651 (UMLS CUI-1)
C49626 (NCIt V19.10d)
CL Item
Exposure (EX)
C1704625 (UMLS CUI-1)
C49587 (NCIt V19.10d)
CL Item
Findings About Events or Interventions (FA)
C2827665 (UMLS CUI-1)
C85442 (NCIt V19.10d)
CL Item
Functional Tests (FT)
C3890579 (UMLS CUI-1)
C117756 (NCIt V19.10d)
CL Item
Gastrointestinal System Findings (GI)
not defined in SDTMIG v3.3 (Comment:en)
C3539617 (UMLS CUI-1)
C102640 (NCIt V19.10d)
CL Item
Hematopoietic System Findings (HM)
not defined in SDTMIG v3.3 (Comment:en)
C3538713 (UMLS CUI-1)
C102641 (NCIt V19.10d)
CL Item
Healthcare Encounters (HO)
C3889614 (UMLS CUI-1)
C117757 (NCIt V19.10d)
CL Item
Inclusion/Exclusion Criteria Not Met (IE)
C1881173 (UMLS CUI-1)
C61536 (NCIt V19.10d)
CL Item
Immunogenicity Specimen Assessments (IS)
C3812801 (UMLS CUI-1)
C112320 (NCIt V19.10d)
CL Item
Laboratory Test Results (LB)
C1705214 (UMLS CUI-1)
C49592 (NCIt V19.10d)
CL Item
Microbiology Specimen (MB)
C1706181 (UMLS CUI-1)
C49602 (NCIt V19.10d)
CL Item
Medical History (MH)
C1704706 (UMLS CUI-1)
C49603 (NCIt V19.10d)
CL Item
Microscopic Findings (MI)
C2986901 (UMLS CUI-1)
C95095 (NCIt V19.10d)
CL Item
Musculoskeletal System Findings (MK)
C3539059 (UMLS CUI-1)
C102674 (NCIt V19.10d)
CL Item
Meal Data (ML)
C1706380 (UMLS CUI-1)
C49604 (NCIt V19.10d)
CL Item
Morphology (MO)
C3538743 (UMLS CUI-1)
C102671 (NCIt V19.10d)
CL Item
Microbiology Susceptibility (MS)
C1881819 (UMLS CUI-1)
C61531 (NCIt V19.10d)
CL Item
Nervous System Findings (NV)
C3540591 (UMLS CUI-1)
C102677 (NCIt V19.10d)
CL Item
Ophthalmic Examinations (OE)
C4552124 (UMLS CUI-1)
C147180 (NCIt V19.10d)
CL Item
Non-host Organism Identifiers (OI)
C5202881 (UMLS CUI-1)
C161329 (NCIt V19.10d)
CL Item
Pharmacogenomics Biomarker (PB)
SDTMIG-PGx (Comment:en)
C3819255 (UMLS CUI-1)
C106552 (NCIt V19.10d)
CL Item
Pharmacokinetics Concentrations (PC)
SDTMIG-PGx (Comment:en)
C1706367 (UMLS CUI-1)
C49606 (NCIt V19.10d)
CL Item
Physical Examination (PE)
C1744699 (UMLS CUI-1)
C49608 (NCIt V19.10d)
CL Item
Pharmacogenomics/Genetics Findings (PF)
SDTMIG-PGx (Comment:en)
C3815179 (UMLS CUI-1)
C111289 (NCIt V19.10d)
CL Item
Pharmacogenomics/Genetics Methods and Supporting Information (PG)
SDTMIG-PGx (Comment:en)
C1882354 (UMLS CUI-1)
C61529 (NCIt V19.10d)
CL Item
Pool Definition (POOLDEF)
SEND (Comment:en)
C4687765 (UMLS CUI-1)
C147181 (NCIt V19.10d)
CL Item
Pharmacokinetic Parameters (PP)
C1705911 (UMLS CUI-1)
C49607 (NCIt V19.10d)
CL Item
Procedures (PR)
C3538935 (UMLS CUI-1)
C102700 (NCIt V19.10d)
CL Item
Questionnaires (QS)
C1706422 (UMLS CUI-1)
C49609 (NCIt V19.10d)
CL Item
Respiratory System Findings (RE)
C2986904 (UMLS CUI-1)
C95098 (NCIt V19.10d)
CL Item
Related Records (RELREC)
C4687766 (UMLS CUI-1)
C147182 (NCIt V19.10d)
CL Item
Related Subjects (RELSUB)
C4552648 (UMLS CUI-1)
C147183 (NCIt V19.10d)
CL Item
Reproductive System Findings (RP)
C3541325 (UMLS CUI-1)
C102707 (NCIt V19.10d)
CL Item
Disease Response and Clin Classification (RS)
C3813325 (UMLS CUI-1)
C107097 (NCIt V19.10d)
CL Item
Subject Biomarker (SB)
SDTMIG-PGx (Comment:en)
C3811240 (UMLS CUI-1)
C106571 (NCIt V19.10d)
CL Item
Subject Characteristics (SC)
C1706465 (UMLS CUI-1)
C49610 (NCIt V19.10d)
CL Item
Subject Elements (SE)
C1705189 (UMLS CUI-1)
C49616 (NCIt V19.10d)
CL Item
Subject Disease Milestones (SM)
C4553627 (UMLS CUI-1)
C147184 (NCIt V19.10d)
CL Item
Skin Response (SR)
C3813610 (UMLS CUI-1)
C112420 (NCIt V19.10d)
CL Item
Subject Status (SS)
C3891295 (UMLS CUI-1)
C117655 (NCIt V19.10d)
CL Item
Substance Use (SU)
C1705534 (UMLS CUI-1)
C49615 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Adverse Events (SUPPAE)
C4687767 (UMLS CUI-1)
C147185 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Procedure Agents (SUPPAG)
C4687768 (UMLS CUI-1)
C147186 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Biospecimen Events (SUPPBE)
SDTMIG-PGx (Comment:en)
C4687769 (UMLS CUI-1)
C147187 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Biospecimen Findings (SUPPBS)
SDTMIG-PGx (Comment:en)
C4687770 (UMLS CUI-1)
C147189 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Clinical Events (SUPPCE)
C4687772 (UMLS CUI-1)
C147191 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Concomitant/Prior Medications (SUPPCM)
C4687774 (UMLS CUI-1)
C147193 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Cardiovascular System Findings (SUPPCV)
C4687776 (UMLS CUI-1)
C147195 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Drug Accountability (SUPPDA)
C4687777 (UMLS CUI-1)
C147196 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Death Details (human clinical trials) (SUPPDD)
C4687778 (UMLS CUI-1)
C147197 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Device Events (SUPPDE)
SDTMIG-MD (Comment:en)
C4687779 (UMLS CUI-1)
C147198 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Demographics (SUPPDM)
C4687781 (UMLS CUI-1)
C147200 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Device Properties (SUPPDO)
SDTMIG-MD (Comment:en)
C4687782 (UMLS CUI-1)
C147201 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Disposition (SUPPDS)
C4687784 (UMLS CUI-1)
C147203 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Device Tracking and Disposition (SUPPDT)
SDTMIG-MD (Comment:en)
C4687785 (UMLS CUI-1)
C147204 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Device In-Use (SUPPDU)
SDTMIG-MD (Comment:en)
C4687786 (UMLS CUI-1)
C147205 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Protocol Deviations (SUPPDV)
C4687787 (UMLS CUI-1)
C147206 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Device Exposure (SUPPDX)
SDTMIG-MD (Comment:en)
C4687788 (UMLS CUI-1)
C147207 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Exposure as Collected (SUPPEC)
C4687789 (UMLS CUI-1)
C147208 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for ECG Test Results (SUPPEG)
C4687790 (UMLS CUI-1)
C147209 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Environmental and Social Factors (SUPPER)
not defined in SDTMIG v3.3 (Comment:en)
C4554000 (UMLS CUI-1)
C147210 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Exposure (SUPPEX)
C4687791 (UMLS CUI-1)
C147211 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Findings About Events or Interventions (SUPPFA)
C4687792 (UMLS CUI-1)
C147212 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Healthcare Encounters (SUPPHO)
C4687796 (UMLS CUI-1)
C147216 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Inclusion/Exclusion Criteria Not Met (SUPPIE)
C4687798 (UMLS CUI-1)
C147218 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Immunogenicity Specimen Assessments (SUPPIS)
C4687799 (UMLS CUI-1)
C147219 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Laboratory Test Results (SUPPLB)
C4687800 (UMLS CUI-1)
C147220 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Microbiology Specimen (SUPPMB)
C4687802 (UMLS CUI-1)
C147222 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Medical History (SUPPMH)
C4687803 (UMLS CUI-1)
C147223 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Microscopic Findings (SUPPMI)
C4687804 (UMLS CUI-1)
C147224 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Musculoskeletal System Findings (SUPPMK)
C4687805 (UMLS CUI-1)
C147225 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Meal Data (SUPPML)
C4687806 (UMLS CUI-1)
C147226 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Microbiology Susceptibility (SUPPMS)
C4687807 (UMLS CUI-1)
C147227 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Nervous System Findings (SUPPNV)
C4687808 (UMLS CUI-1)
C147228 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Ophthalmic Examinations (SUPPOE)
C4687809 (UMLS CUI-1)
C147229 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Pharmacogenomics/Genetics Biomarker (SUPPPB)
SDTMIG-PGx (Comment:en)
C4687812 (UMLS CUI-1)
C147232 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Pharmacokinetics Concentrations (SUPPPC)
C4687813 (UMLS CUI-1)
C147233 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Physical Examination (SUPPPE)
C4687814 (UMLS CUI-1)
C147234 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Pharmacogenomics/Genetics Findings (SUPPPF)
SDTMIG-PGx (Comment:en)
C4687815 (UMLS CUI-1)
C147235 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Pharmacogenomics/Genetics Methods and Supporting Information (SUPPPG)
SDTMIG-PGx (Comment:en)
C4687816 (UMLS CUI-1)
C147236 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Pharmacokinetic Parameters (SUPPPP)
C4687818 (UMLS CUI-1)
C147238 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Procedures (SUPPPR)
C4687819 (UMLS CUI-1)
C147239 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Questionnaires (SUPPQS)
C4687820 (UMLS CUI-1)
C147240 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for ECG QT Correction Model Data (SUPPQT)
not defined in SDTMIG v3.3 (Comment:en)
C4687821 (UMLS CUI-1)
C147241 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Respiratory Test Results (SUPPRE)
C4687822 (UMLS CUI-1)
C147242 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Reproductive System Findings (SUPPRP)
C4687823 (UMLS CUI-1)
C147243 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Disease Response (SUPPRS)
C4687824 (UMLS CUI-1)
C147244 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Subject Biomarker (SUPPSB)
C4687825 (UMLS CUI-1)
C147245 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Subject Characteristics (SUPPSC)
C4687826 (UMLS CUI-1)
C147246 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Subject Disease Milestones (SUPPSM)
C4687829 (UMLS CUI-1)
C147249 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Skin Response (SUPPSR)
C4687830 (UMLS CUI-1)
C147250 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Subject Status (SUPPSS)
C4687831 (UMLS CUI-1)
C147251 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Substance Use (SUPPSU)
C4687832 (UMLS CUI-1)
C147252 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Tumor Response (SUPPTR)
C4687841 (UMLS CUI-1)
C147261 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Tumor/Lesion Identification (SUPPTU)
C4687844 (UMLS CUI-1)
C147264 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Urinary System Findings (SUPPUR)
C4687846 (UMLS CUI-1)
C147267 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Vital Signs (SUPPVS)
C4687847 (UMLS CUI-1)
C147268 (NCIt V19.10d)
CL Item
Supplemental Qualifiers for Whole Body Findings (SUPPWB)
not defined in SDTMIG v3.3 (Comment:en)
C4687848 (UMLS CUI-1)
C147269 (NCIt V19.10d)
CL Item
Subject Visits (SV)
C1704677 (UMLS CUI-1)
C49617 (NCIt V19.10d)
CL Item
Trial Arms (TA)
C1705538 (UMLS CUI-1)
C49618 (NCIt V19.10d)
CL Item
Trial Disease Assessments (TD)
C3889651 (UMLS CUI-1)
C117699 (NCIt V19.10d)
CL Item
Trial Elements (TE)
C1705540 (UMLS CUI-1)
C49619 (NCIt V19.10d)
CL Item
Trial Inclusion/Exclusion Criteria (TI)
C1704756 (UMLS CUI-1)
C49620 (NCIt V19.10d)
CL Item
Trial Disease Milestones (TM)
C4552802 (UMLS CUI-1)
C147270 (NCIt V19.10d)
CL Item
Tumor/Lesion Results (TR)
C3814152 (UMLS CUI-1)
C106578 (NCIt V19.10d)
CL Item
Trial Summary (TS)
C1704618 (UMLS CUI-1)
C53483 (NCIt V19.10d)
CL Item
Tumor/Lesion Identification (TU)
C3811255 (UMLS CUI-1)
C106577 (NCIt V19.10d)
CL Item
Trial Visits (TV)
C1704705 (UMLS CUI-1)
C49621 (NCIt V19.10d)
CL Item
Trial Sets (TX)
C2986909 (UMLS CUI-1)
C95103 (NCIt V19.10d)
CL Item
Urinary System Findings (UR)
C3541338 (UMLS CUI-1)
C102726 (NCIt V19.10d)
CL Item
Vital Signs (VS)
C1704629 (UMLS CUI-1)
C49622 (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
text
C2348184 (UMLS CUI [1])
COSEQ (SDTMIG 3.3)
C83240 (NCIt V19.10d)
IDVAR
Item
Identifying Variable
text
C0600091 (UMLS CUI [1,1])
C0439828 (UMLS CUI [1,2])
IDVAR (SDTMIG 3.3)
C83293 (NCIt V19.10d)
IDVARVAL
Item
Identifying Variable Value
text
C0600091 (UMLS CUI [1,1])
C0439828 (UMLS CUI [1,2])
IDVARVAL (SDTMIG 3.3)
C83294 (NCIt V19.10d)
REF
Item
Comment Reference
text
C0947611 (UMLS CUI [1,1])
C1706462 (UMLS CUI [1,2])
COREF (SDTMIG 3.3)
C82504 (NCIt V19.10d)
VAL
Item
Comment
text
C0947611 (UMLS CUI [1])
COVAL (SDTMIG 3.3)
C83241 (NCIt V19.10d)
EVAL
Item
Evaluator
text
C0947611 (UMLS CUI [1,1])
C1707957 (UMLS CUI [1,2])
COEVAL (SDTMIG 3.3)
C83239 (NCIt V19.10d)
Item
Evaluator Identifier
text
C0947611 (UMLS CUI [1,1])
C1707957 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
COEVALID (SDTMIG 3.3)
C117043 (NCIt V19.10d)
C49569 (NCIt V19.10d-2)
EVALID
Code List
Evaluator Identifier
CL Item
ADJUDICATOR (ADJUDICATOR)
C0401783 (UMLS CUI-1)
C96561 (NCIt V19.10d)
CL Item
ADJUDICATOR 1 (ADJUDICATOR 1)
C4726039 (UMLS CUI-1)
C150867 (NCIt V19.10d)
CL Item
ADJUDICATOR 2 (ADJUDICATOR 2)
C4726040 (UMLS CUI-1)
C150868 (NCIt V19.10d)
CL Item
ADJUDICATOR 3 (ADJUDICATOR 3)
C4726041 (UMLS CUI-1)
C150869 (NCIt V19.10d)
CL Item
CARDIOLOGIST (CARDIOLOGIST)
C0175906 (UMLS CUI-1)
C125951 (NCIt V19.10d)
CL Item
CLINICAL PATHOLOGIST (CLINICAL PATHOLOGIST)
C0334901 (UMLS CUI-1)
C142332 (NCIt V19.10d)
CL Item
DERMATOLOGIST (DERMATOLOGIST)
C0259831 (UMLS CUI-1)
C17816 (NCIt V19.10d)
CL Item
DEVELOPMENTAL BEHAVIORAL PEDIATRICIAN (DEVELOPMENTAL BEHAVIORAL PEDIATRICIAN)
C4687932 (UMLS CUI-1)
C147461 (NCIt V19.10d)
CL Item
DEVELOPMENTAL PSYCHOLOGIST (DEVELOPMENTAL PSYCHOLOGIST)
C4688605 (UMLS CUI-1)
C147462 (NCIt V19.10d)
CL Item
FORENSIC PATHOLOGIST (FORENSIC PATHOLOGIST)
C4684530 (UMLS CUI-1)
C142333 (NCIt V19.10d)
CL Item
HEMATOLOGIST (HEMATOLOGIST)
C0278598 (UMLS CUI-1)
C17831 (NCIt V19.10d)
CL Item
MICROSCOPIST (MICROSCOPIST)
C4330683 (UMLS CUI-1)
C132303 (NCIt V19.10d)
CL Item
MICROSCOPIST 1 (MICROSCOPIST 1)
C4330680 (UMLS CUI-1)
C132421 (NCIt V19.10d)
CL Item
MICROSCOPIST 2 (MICROSCOPIST 2)
C4330681 (UMLS CUI-1)
C132422 (NCIt V19.10d)
CL Item
MICROSCOPIST 3 (MICROSCOPIST 3)
C4330682 (UMLS CUI-1)
C132423 (NCIt V19.10d)
CL Item
NEUROLOGIST (NEUROLOGIST)
C0237426 (UMLS CUI-1)
C17721 (NCIt V19.10d)
CL Item
NEUROLOGIST 1 (NEUROLOGIST 1)
C3272968 (UMLS CUI-1)
C96692 (NCIt V19.10d)
CL Item
NEUROLOGIST 2 (NEUROLOGIST 2)
C3272896 (UMLS CUI-1)
C96606 (NCIt V19.10d)
CL Item
ONCOLOGIST (ONCOLOGIST)
C0259990 (UMLS CUI-1)
C17821 (NCIt V19.10d)
CL Item
ONCOLOGIST 1 (ONCOLOGIST 1)
C3272901 (UMLS CUI-1)
C96611 (NCIt V19.10d)
CL Item
ONCOLOGIST 2 (ONCOLOGIST 2)
C3272902 (UMLS CUI-1)
C96612 (NCIt V19.10d)
CL Item
OPHTHALMOLOGIST (OPHTHALMOLOGIST)
C1704292 (UMLS CUI-1)
C17822 (NCIt V19.10d)
CL Item
OPTOMETRIST (OPTOMETRIST)
C0029146 (UMLS CUI-1)
C132424 (NCIt V19.10d)
CL Item
PATHOLOGIST (PATHOLOGIST)
C0334866 (UMLS CUI-1)
C17723 (NCIt V19.10d)
CL Item
PATHOLOGIST 1 (PATHOLOGIST 1)
C4743735 (UMLS CUI-1)
C154836 (NCIt V19.10d)
CL Item
PATHOLOGIST 2 (PATHOLOGIST 2)
C4743736 (UMLS CUI-1)
C154837 (NCIt V19.10d)
CL Item
PEDIATRIC NEUROLOGIST (PEDIATRIC NEUROLOGIST)
C0586846 (UMLS CUI-1)
C147463 (NCIt V19.10d)
CL Item
Physical Therapist (PHYSIOTHERAPIST)
C2362565 (UMLS CUI-1)
C53422 (NCIt V19.10d)
CL Item
RADIOLOGIST (RADIOLOGIST)
C0260194 (UMLS CUI-1)
C17824 (NCIt V19.10d)
CL Item
RADIOLOGIST 1 (RADIOLOGIST 1)
C2986554 (UMLS CUI-1)
C94530 (NCIt V19.10d)
CL Item
RADIOLOGIST 2 (RADIOLOGIST 2)
C2986555 (UMLS CUI-1)
C94531 (NCIt V19.10d)
CL Item
RATER (RATER)
C4331219 (UMLS CUI-1)
C132304 (NCIt V19.10d)
CL Item
RATER 1 (RATER 1)
C4331218 (UMLS CUI-1)
C132425 (NCIt V19.10d)
CL Item
RATER 2 (RATER 2)
C4331939 (UMLS CUI-1)
C132426 (NCIt V19.10d)
CL Item
READER (READER)
C1514743 (UMLS CUI-1)
C28747 (NCIt V19.10d)
CL Item
READER 1 (READER 1)
C2986556 (UMLS CUI-1)
C94532 (NCIt V19.10d)
CL Item
READER 2 (READER 2)
C2986557 (UMLS CUI-1)
C94533 (NCIt V19.10d)
CL Item
READER 3 (READER 3)
C4528333 (UMLS CUI-1)
C139209 (NCIt V19.10d)
CL Item
UROLOGIST (UROLOGIST)
C0260314 (UMLS CUI-1)
C17826 (NCIt V19.10d)
DTC
Item
Date/Time of Comment
datetime
C1264639 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
CODTC (SDTMIG 3.3)
C83238 (NCIt V19.10d)
DY
Item
Study Day of Comment
integer
C0947611 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
CODY (SDTMIG 3.3)
C119819 (NCIt V19.10d)
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