English

Observation Class: Events - Domain: Protocol Deviations

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
Protocol Deviations
Description

Protocol Deviations

Alias
SDTMIG v3.3
DV
UMLS CUI-1
C1705236
NCIt V19.10d:
C49585
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): DV

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]
C1705236
UMLS CUI [1,2]
C2348184
SDTMIG 3.3
DVSEQ
NCIt V19.10d
C87994
Reference ID
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Internal or external identifier. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C2826265
SDTMIG 3.3
DVREFID
NCIt V19.10d
C87993
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 on a CRF page. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C2347796
UMLS CUI [1,3]
C0600091
SDTMIG 3.3
DVSPID
NCIt V19.10d
C83077
Protocol Deviation Term
Description

Role: Topic CDISC Notes (for domains) Description (for General Classes): Verbatim name of the protocol deviation criterion. Example: "IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED". The DVTERM values will map to the controlled terminology in DVDECOD, such as "TREATMENT DEVIATION". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1]
C1705236
SDTMIG 3.3
DVTERM
NCIt V19.10d
C50996
Protocol Deviation Coded Term
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): Controlled terminology for the name of the protocol deviation. Examples: "SUBJECT NOT WITHDRAWN AS PER PROTOCOL", "SELECTION CRITERIA NOT MET", "EXCLUDED CONCOMITANT MEDICATION", "TREATMENT DEVIATION". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0027365
SDTMIG 3.3
DVDECOD
NCIt V19.10d
C83123
Category for Protocol Deviation
Description

Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): Category of the protocol deviation criterion. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0683312
SDTMIG 3.3
DVCAT
NCIt V19.10d
C87990
Subcategory for Protocol Deviation
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C1515010
SDTMIG 3.3
DVSCAT
NCIt V19.10d
C87996
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 deviation. Examples: "TREATMENT", "SCREENING", "FOLLOW-UP". Controlled Terms or Format (if applicable): (EPOCH), extensible

Data type

text

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

Role: Timing CDISC Notes (for domains) Description (for General Classes): Start date/time of deviation represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1705236
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C1705236
SDTMIG 3.3
DVSTDTC
NCIt V19.10d
C87995
End Date/Time of Deviation
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): End date/time of deviation represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1705236
UMLS CUI [2,1]
C1522314
UMLS CUI [2,2]
C1705236
SDTMIG 3.3
DVENDTC
NCIt V19.10d
C1522314
Study Day of Start of Deviation Event
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of start of event relative to the sponsor-defined RFSTDTC. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C2826182
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C1705236
SDTMIG 3.3
DVSTDY
NCIt V19.10d
C82570
NCIt V19.10d-2
C49585
Study Day of End of Observation
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of end of event relative to the sponsor-defined RFSTDTC. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C2826182
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C1705236
SDTMIG 3.3
DVENDY
NCIt V19.10d
C82569
NCIt V19.10d-2
C49585
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Similar models

Observation Class: Events - Domain: Protocol Deviations

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
Protocol Deviations
DV (SDTMIG v3.3)
C1705236 (UMLS CUI-1)
C49585 (NCIt V19.10d:)
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
C1705236 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
DVSEQ (SDTMIG 3.3)
C87994 (NCIt V19.10d)
REFID
Item
Reference ID
text
C1705236 (UMLS CUI [1,1])
C2826265 (UMLS CUI [1,2])
DVREFID (SDTMIG 3.3)
C87993 (NCIt V19.10d)
SPID
Item
Sponsor-Defined Identifier
text
C1705236 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
DVSPID (SDTMIG 3.3)
C83077 (NCIt V19.10d)
TERM
Item
Protocol Deviation Term
text
C1705236 (UMLS CUI [1])
DVTERM (SDTMIG 3.3)
C50996 (NCIt V19.10d)
DECOD
Item
Protocol Deviation Coded Term
text
C1705236 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
DVDECOD (SDTMIG 3.3)
C83123 (NCIt V19.10d)
CAT
Item
Category for Protocol Deviation
text
C1705236 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
DVCAT (SDTMIG 3.3)
C87990 (NCIt V19.10d)
SCAT
Item
Subcategory for Protocol Deviation
text
C1705236 (UMLS CUI [1,1])
C1515010 (UMLS CUI [1,2])
DVSCAT (SDTMIG 3.3)
C87996 (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)
STDTC
Item
Start Date/Time of Deviation
datetime
C0808070 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C1705236 (UMLS CUI [2,2])
DVSTDTC (SDTMIG 3.3)
C87995 (NCIt V19.10d)
ENDTC
Item
End Date/Time of Deviation
datetime
C0806020 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C1705236 (UMLS CUI [2,2])
DVENDTC (SDTMIG 3.3)
C1522314 (NCIt V19.10d)
STDY
Item
Study Day of Start of Deviation Event
text
C2826182 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
DVSTDY (SDTMIG 3.3)
C82570 (NCIt V19.10d)
C49585 (NCIt V19.10d-2)
ENDY
Item
Study Day of End of Observation
text
C2826182 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
DVENDY (SDTMIG 3.3)
C82569 (NCIt V19.10d)
C49585 (NCIt V19.10d-2)
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