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Observation Class: Findings - Domain: Death Details

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
Death Details
Description

Death Details

Alias
SDTMIG v3.3
DD
UMLS CUI-1
C0011065
UMLS CUI-2
C1522508
NCIt V19.10d:
C95087
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): DD

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]
C0011065
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C2348184
SDTMIG 3.3
DDSEQ
NCIt V19.10d
C117543
Death Detail Assessment Short Name
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0392366
UMLS CUI [1,4]
C1806781
UMLS CUI [1,5]
C0027365
SDTMIG 3.3
DDTESTCD
NCIt V19.10d
C117544
Death Detail Assessment Name
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): Long name for DDTESTCD. The value in DDTEST cannot be longer than 40 characters. Examples: "Primary Cause of Death", "Secondary Cause of Death". Controlled Terms or Format (if applicable): (DTHDX), extensible

Data type

text

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0392366
UMLS CUI [1,4]
C0027365
SDTMIG 3.3
DDTEST
NCIt V19.10d
C117545
Result or Finding as Collected
Description

Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): Result of the test defined in DDTEST, as originally received or collected. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0205313
SDTMIG 3.3
DDORRES
NCIt V19.10d
C117546
Character Result/Finding in Std Format
Description

Role: Result Qualifier CDISC Notes (for domains) Description (for General Classes): Contains the result or finding copied or derived from DDORRES in a standard format. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C2350015
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1442989
UMLS CUI [1,5]
C1301627
SDTMIG 3.3
DDSTRESC
NCIt V19.10d
C117547
Result Category
Description

Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Used to categorize the result of a finding. Examples: "TREATMENT RELATED", "NONTREATMENT RELATED", "UNDETERMINED", "ACCIDENTAL". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0683312
SDTMIG 3.3
DDRESCAT
NCIt V19.10d
C102742
Evaluator
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Role of the person who provided the evaluation. Controlled Terms or Format (if applicable): (EVAL), extensible

Data type

text

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1707957
SDTMIG 3.3
DDEVAL
NCIt V19.10d
C117548
Date/Time of Collection
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Date/time of collection of the diagnosis or other death assessment data in ISO 8601 format. This is not necessarily the date of death. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0011065
UMLS CUI [1,3]
C1522508
UMLS CUI [1,4]
C1516698
SDTMIG 3.3
DDDTC
NCIt V19.10d
C117549
Study Day of Collection
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Study day of the collection, 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]
C2826182
UMLS CUI [1,2]
C0011065
UMLS CUI [1,3]
C1522508
UMLS CUI [1,4]
C1516698
SDTMIG 3.3
DDDY
NCIt V19.10d
C117550
d
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Similar models

Observation Class: Findings - Domain: Death Details

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
Death Details
DD (SDTMIG v3.3)
C0011065 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
C95087 (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
C0011065 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
DDSEQ (SDTMIG 3.3)
C117543 (NCIt V19.10d)
Item
Death Detail Assessment Short Name
text
C0011065 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0392366 (UMLS CUI [1,3])
C1806781 (UMLS CUI [1,4])
C0027365 (UMLS CUI [1,5])
DDTESTCD (SDTMIG 3.3)
C117544 (NCIt V19.10d)
TESTCD
Code List
Death Detail Assessment Short Name
CL Item
Age at Death (AGEDTH)
CL Item
Autopsy Indicator (AUTOPIND)
CL Item
Death Certificate Obtained Indicator (DTHCOIND)
CL Item
Hospital Medical Record Obtained Ind; Hospital Medical Record Obtained Indicator (HMROIND)
CL Item
Location of Death (LOCDTH)
CL Item
Primary Cause of Death (PRCDTH)
CL Item
Secondary Cause of Death (SECDTH)
Item
Death Detail Assessment Name
text
C0011065 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0392366 (UMLS CUI [1,3])
C0027365 (UMLS CUI [1,4])
DDTEST (SDTMIG 3.3)
C117545 (NCIt V19.10d)
TEST
Code List
Death Detail Assessment Name
CL Item
Age at Death (Age at Death)
CL Item
Autopsy Indicator (Autopsy Indicator)
CL Item
Death Certificate Obtained Indicator (Death Certificate Obtained Indicator)
CL Item
Hospital Medical Record Obtained Ind; Hospital Medical Record Obtained Indicator (Hospital Medical Record Obtained Ind)
CL Item
Location of Death (Location of Death)
CL Item
Primary Cause of Death (Primary Cause of Death)
CL Item
Secondary Cause of Death (Secondary Cause of Death)
ORRES
Item
Result or Finding as Collected
text
C0011065 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0205313 (UMLS CUI [1,3])
DDORRES (SDTMIG 3.3)
C117546 (NCIt V19.10d)
STRESC
Item
Character Result/Finding in Std Format
text
C0011065 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1442989 (UMLS CUI [1,4])
C1301627 (UMLS CUI [1,5])
DDSTRESC (SDTMIG 3.3)
C117547 (NCIt V19.10d)
RESCAT
Item
Result Category
text
C0011065 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,3])
DDRESCAT (SDTMIG 3.3)
C102742 (NCIt V19.10d)
Item
Evaluator
text
C0011065 (UMLS CUI [1,1])
C1707957 (UMLS CUI [1,2])
DDEVAL (SDTMIG 3.3)
C117548 (NCIt V19.10d)
EVALID
Code List
Evaluator
CL Item
ADJUDICATION COMMITTEE  (ADJUDICATION COMMITTEE )
CL Item
ADJUDICATOR  (ADJUDICATOR )
CL Item
Caregiver (CAREGIVER)
CL Item
CHILD  (CHILD )
CL Item
Research Associate (CLINICAL RESEARCH ASSOCIATE)
CL Item
CRC (CLINICAL RESEARCH COORDINATOR)
CL Item
Clinical Study Sponsor; Sponsor; Study Sponsor (CLINICAL STUDY SPONSOR)
CL Item
Domestic Partner (DOMESTIC PARTNER)
CL Item
Family Member (FAMILY MEMBER)
CL Item
FRIEND  (FRIEND )
CL Item
GUARDIAN  (GUARDIAN )
CL Item
HEALTH CARE PROFESSIONAL  (HEALTH CARE PROFESSIONAL )
CL Item
INDEPENDENT ASSESSOR  (INDEPENDENT ASSESSOR )
CL Item
INTERVIEWER  (INTERVIEWER )
CL Item
INVESTIGATOR  (INVESTIGATOR )
CL Item
PARENT  (PARENT )
CL Item
PROXY  (PROXY )
CL Item
SIBLING  (SIBLING )
CL Item
SIGNIFICANT OTHER  (SIGNIFICANT OTHER )
CL Item
Spouse (SPOUSE)
CL Item
STUDY SUBJECT  (STUDY SUBJECT )
CL Item
VENDOR  (VENDOR )
DTC
Item
Date/Time of Collection
datetime
C1264639 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,4])
DDDTC (SDTMIG 3.3)
C117549 (NCIt V19.10d)
DY
Item
Study Day of Collection
integer
C2826182 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,4])
DDDY (SDTMIG 3.3)
C117550 (NCIt V19.10d)
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