English

Observation Class: Trial Design - Domain: Trial Summary Information

59 forms  
  1. StudyEvent: ODM
    1. Observation Class: Special Purpose - Domain: Comments
    2. Observation Class: Special Purpose - Domain: Demographics
    3. Observation Class: Special Purpose - Domain: Subject Elements
    4. Observation Class: Special Purpose - Domain: Subject Disease Milestones
    5. Observation Class: Special Purpose - Domain: Subject Visits
    6. Observation Class: Interventions - Domain: Procedure Agents
    7. Observation Class: Interventions - Domain: Concomitant/Prior Medications
    8. Observation Class: Interventions - Domain: Exposure
    9. Observation Class: Interventions - Domain: Exposure as Collected
    10. Observation Class: Interventions - Domain: Meal Data
    11. Observation Class: Interventions - Domain: Procedures
    12. Observation Class: Interventions - Domain: Substance Use
    13. Observation Class: Events - Domain: Adverse Events
    14. Observation Class: Events - Domain: Clinical Events
    15. Observation Class: Events - Domain: Disposition
    16. Observation Class: Events - Domain: Protocol Deviations
    17. Observation Class: Events - Domain: Healthcare Encounters
    18. Observation Class: Events - Domain: Medical History
    19. Observation Class: Findings - Domain: Drug Accountability
    20. Observation Class: Findings - Domain: Death Details
    21. Observation Class: Findings - Domain: ECG Test Results
    22. Observation Class: Findings - Domain: Inclusion/Exclusion Criteria Not Met
    23. Observation Class: Findings - Domain: Immunogenicity Specimen Assessments
    24. Observation Class: Findings - Domain: Laboratory Test Results
    25. Observation Class: Findings - Domain: Microbiology Specimen
    26. Observation Class: Findings - Domain: Microbiology Susceptibility
    27. Observation Class: Findings - Domain: Microscopic Findings
    28. Observation Class: Findings - Domain: Morphology
    29. Observation Class: Findings - Domain: Cardiovascular System Findings
    30. Observation Class: Findings - Domain: Musculoskeletal System Findings
    31. Observation Class: Findings - Domain: Nervous System Findings
    32. Observation Class: Findings - Domain: Ophthalmic Examinations
    33. Observation Class: Findings - Domain: Reproductive System Findings
    34. Observation Class: Findings - Domain: Respiratory System Findings
    35. Observation Class: Findings - Domain: Urinary System Findings
    36. Observation Class: Findings - Domain: Pharmacokinetics Concentrations
    37. Observation Class: Findings - Domain: Pharmacokinetics Parameters
    38. Observation Class: Findings - Domain: Physical Examination
    39. Observation Class: Findings - Domain: Functional Tests
    40. Observation Class: Findings - Domain: Questionnaires
    41. Observation Class: Findings - Domain: Disease Response and Clin Classification
    42. Observation Class: Findings - Domain: Subject Characteristics
    43. Observation Class: Findings - Domain: Subject Status
    44. Observation Class: Findings - Domain: Tumor/Lesion Identification
    45. Observation Class: Findings - Domain: Tumor/Lesion Results
    46. Observation Class: Findings - Domain: Vital Signs
    47. Observation Class: Findings - Domain: Findings About Events or Interventions
    48. Observation Class: Findings - Domain: Skin Response
    49. Observation Class: Trial Design - Domain: Trial Arms
    50. Observation Class: Trial Design - Domain: Trial Elements
    51. Observation Class: Trial Design - Domain: Trial Visits
    52. Observation Class: Trial Design - Domain: Trial Disease Assessments
    53. Observation Class: Trial Design - Domain: Trial Disease Milestones
    54. Observation Class: Trial Design - Domain: Trial Inclusion/Exclusion Criteria
    55. Observation Class: Trial Design - Domain: Trial Summary Information
    56. Observation Class: Relationships - Domain: Related Records
    57. Observation Class: Relationships - Domain: Supplemental Qualifiers for [domain name]
    58. Observation Class: Relationships - Domain: Related Subjects
    59. Observation Class: Study Reference - Domain: Non-host Organism Identifiers
Trial Summary Information
Description

Trial Summary Information

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

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

Data type

text

Alias
UMLS CUI [1]
C2826693
SDTMIG 3.3
STUDYID
NCIt V19.10d
C83082
Domain Abbreviation
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain. Controlled Terms or Format (if applicable): TS

Data type

text

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

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

Data type

integer

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

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

Data type

text

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

Role: Topic CDISC Notes (for domains) Description (for General Classes): TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that TSPARMCD will need to serve as variable names. Examples: "AGEMIN", "AGEMAX". Controlled Terms or Format (if applicable): (TSPARMCD), extensible

Data type

text

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

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

Data type

text

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

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

Data type

text

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

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

Data type

text

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

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

Data type

text

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

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

Data type

text

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

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

Data type

text

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

Observation Class: Trial Design - Domain: Trial Summary Information

59 forms
  1. StudyEvent: ODM
    1. Observation Class: Special Purpose - Domain: Comments
    2. Observation Class: Special Purpose - Domain: Demographics
    3. Observation Class: Special Purpose - Domain: Subject Elements
    4. Observation Class: Special Purpose - Domain: Subject Disease Milestones
    5. Observation Class: Special Purpose - Domain: Subject Visits
    6. Observation Class: Interventions - Domain: Procedure Agents
    7. Observation Class: Interventions - Domain: Concomitant/Prior Medications
    8. Observation Class: Interventions - Domain: Exposure
    9. Observation Class: Interventions - Domain: Exposure as Collected
    10. Observation Class: Interventions - Domain: Meal Data
    11. Observation Class: Interventions - Domain: Procedures
    12. Observation Class: Interventions - Domain: Substance Use
    13. Observation Class: Events - Domain: Adverse Events
    14. Observation Class: Events - Domain: Clinical Events
    15. Observation Class: Events - Domain: Disposition
    16. Observation Class: Events - Domain: Protocol Deviations
    17. Observation Class: Events - Domain: Healthcare Encounters
    18. Observation Class: Events - Domain: Medical History
    19. Observation Class: Findings - Domain: Drug Accountability
    20. Observation Class: Findings - Domain: Death Details
    21. Observation Class: Findings - Domain: ECG Test Results
    22. Observation Class: Findings - Domain: Inclusion/Exclusion Criteria Not Met
    23. Observation Class: Findings - Domain: Immunogenicity Specimen Assessments
    24. Observation Class: Findings - Domain: Laboratory Test Results
    25. Observation Class: Findings - Domain: Microbiology Specimen
    26. Observation Class: Findings - Domain: Microbiology Susceptibility
    27. Observation Class: Findings - Domain: Microscopic Findings
    28. Observation Class: Findings - Domain: Morphology
    29. Observation Class: Findings - Domain: Cardiovascular System Findings
    30. Observation Class: Findings - Domain: Musculoskeletal System Findings
    31. Observation Class: Findings - Domain: Nervous System Findings
    32. Observation Class: Findings - Domain: Ophthalmic Examinations
    33. Observation Class: Findings - Domain: Reproductive System Findings
    34. Observation Class: Findings - Domain: Respiratory System Findings
    35. Observation Class: Findings - Domain: Urinary System Findings
    36. Observation Class: Findings - Domain: Pharmacokinetics Concentrations
    37. Observation Class: Findings - Domain: Pharmacokinetics Parameters
    38. Observation Class: Findings - Domain: Physical Examination
    39. Observation Class: Findings - Domain: Functional Tests
    40. Observation Class: Findings - Domain: Questionnaires
    41. Observation Class: Findings - Domain: Disease Response and Clin Classification
    42. Observation Class: Findings - Domain: Subject Characteristics
    43. Observation Class: Findings - Domain: Subject Status
    44. Observation Class: Findings - Domain: Tumor/Lesion Identification
    45. Observation Class: Findings - Domain: Tumor/Lesion Results
    46. Observation Class: Findings - Domain: Vital Signs
    47. Observation Class: Findings - Domain: Findings About Events or Interventions
    48. Observation Class: Findings - Domain: Skin Response
    49. Observation Class: Trial Design - Domain: Trial Arms
    50. Observation Class: Trial Design - Domain: Trial Elements
    51. Observation Class: Trial Design - Domain: Trial Visits
    52. Observation Class: Trial Design - Domain: Trial Disease Assessments
    53. Observation Class: Trial Design - Domain: Trial Disease Milestones
    54. Observation Class: Trial Design - Domain: Trial Inclusion/Exclusion Criteria
    55. Observation Class: Trial Design - Domain: Trial Summary Information
    56. Observation Class: Relationships - Domain: Related Records
    57. Observation Class: Relationships - Domain: Supplemental Qualifiers for [domain name]
    58. Observation Class: Relationships - Domain: Related Subjects
    59. Observation Class: Study Reference - Domain: Non-host Organism Identifiers
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Trial Summary Information
TS (SDTMIG v3.3)
C53483 (NCIt V19.10d:)
C0008976 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
STUDYID
Item
Study Identifier
text
C2826693 (UMLS CUI [1])
STUDYID (SDTMIG 3.3)
C83082 (NCIt V19.10d)
DOMAIN
Item
Domain Abbreviation
text
C1883204 (UMLS CUI [1,1])
C0000723 (UMLS CUI [1,2])
DOMAIN (SDTMIG 3.3)
C49556 (NCIt V19.10d)
SEQ
Item
Sequence Number
integer
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
TSSEQ (SDTMIG 3.3)
C83446 (NCIt V19.10d)
GRPID
Item
Group ID
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
TSGRPID (SDTMIG 3.3)
C88007 (NCIt V19.10d)
Item
Trial Summary Parameter Short Name
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
C1806781 (UMLS CUI [1,4])
C0027365 (UMLS CUI [1,5])
TSPARMCD (SDTMIG 3.3)
C83445 (NCIt V19.10d)
PARMCD
Code List
Trial Summary Parameter Short Name
CL Item
Actual Number of Subjects (ACTSUB)
CL Item
Adaptive Design (ADAPT)
CL Item
Added on to Existing Treatments (ADDON)
CL Item
Planned Maximum Age of Subjects (AGEMAX)
CL Item
Planned Minimum Age of Subjects (AGEMIN)
CL Item
Biospecimen Retention Contains DNA (BIOSPRET)
CL Item
Blinded Status SDTM Dataset Generation; Blinded Status at SDTM Dataset Generation (BLNDSTAT)
CL Item
Citation Used in Study (CITNSTDY)
CL Item
Commercial Sponsor Status (CMSPSTAT)
CL Item
Comparative Treatment Name (COMPTRT)
CL Item
Confirmed Response Minimum Duration (CRMDUR)
CL Item
Clinical Study Report Archive Date (CSRARDTC)
CL Item
CDISC Therapeutic Area User Guide (CTAUG)
CL Item
Current Therapy or Treatment (CURTRT)
CL Item
Data Cutoff Description (DCUTDESC)
CL Item
Data Cutoff Date (DCUTDTC)
CL Item
Delayed Graft Function Diagnostic Criteria; Delayed Graft Function Dx Criteria (DGFCRIT)
CL Item
Data Monitoring Committee Indicator (DMCIND)
CL Item
Dose Level; Dose per Administration (DOSE)
CL Item
Dose Form (DOSFRM)
CL Item
Dosing Frequency (DOSFRQ)
CL Item
Dose Regimen (DOSRGM)
CL Item
Dose Units (DOSU)
CL Item
Diagnostic Criteria (DXCRIT)
CL Item
ECG Reading Blinded (EGBLIND)
CL Item
ECG Continuous Monitoring (EGCTMON)
CL Item
ECG Planned Primary Lead (EGLEADPR)
CL Item
ECG Used Same Lead (EGLEADSM)
CL Item
ECG Read Method (EGRDMETH)
CL Item
ECG Replicates at Baseline (EGREPLBL)
CL Item
ECG Replicates On-Treatment (EGREPLTR)
CL Item
ECG Twave Algorithm (EGTWVALG)
CL Item
Email Address for XML File (EMAILXML)
CL Item
EMA Decision Number for PIP (EMPIPDCN)
CL Item
EudraCT Resubmission Indicator (EURSBIND)
CL Item
EudraVigilance Sender ID (EVSNDID)
CL Item
EudraVigilance Sender Organization (EVSNDORG)
CL Item
Expanded Access Record NCT Number (EXPARECN)
CL Item
Expanded Access Status (EXPASTAT)
CL Item
Extension Trial Indicator (EXTTIND)
CL Item
Planned Country of Investigational Sites (FCNTRY)
CL Item
FDA-Regulated Device Study Indicator (FDADEIND)
CL Item
FDA-Regulated Drug Study Indicator (FDADRIND)
CL Item
FDA Technical Specification (FDATCHSP)
CL Item
Healthy Subject Indicator (HLTSUBJI)
CL Item
Trial Disease/Condition Indication (INDIC)
CL Item
Intervention Model (INTMODEL)
CL Item
Intervention Type (INTTYPE)
CL Item
Protocol Keyword (KEYWORD)
CL Item
Trial Length (LENGTH)
CL Item
Country of Manufacture (MNFCNTRY)
CL Item
Multiple Site EU State Trial Indicator (MSEUTIND)
CL Item
Planned Number of Arms (NARMS)
CL Item
Number of Groups/Cohorts (NCOHORT)
CL Item
Number of Trial Sites EU State (NUMSEUST)
CL Item
Trial Exploratory Objective (OBJEXP)
CL Item
Trial Primary Objective (OBJPRIM)
CL Item
Trial Secondary Objective (OBJSEC)
CL Item
Observational Model (OBSMODEL)
CL Item
Observational Time Perspective (OBSTIMP)
CL Item
Obs Study Population Description (OBSTPOPD)
CL Item
Observational Study Sampling Method (OBSTSMM)
CL Item
Obs Study Sampling Method Description (OBSTSMMD)
CL Item
Additional Outcome Measure (OUTMSADD)
CL Item
Exploratory Outcome Measure (OUTMSEXP)
CL Item
Primary Outcome Measure (OUTMSPRI)
CL Item
Secondary Outcome Measure (OUTMSSEC)
CL Item
Post Authorization Safety Study Ind (PASSIND)
CL Item
Pharmacologic Class (PCLAS)
CL Item
Pediatric Postmarket Study Indicator (PDPSTIND)
CL Item
Pediatric Study Indicator (PDSTIND)
CL Item
Pediatric Investigation Plan Indicator (PIPIND)
CL Item
Anticipated Enrollment; Planned Enrollment; Planned Number of Subjects; Target Enrollment (PLANSUB)
CL Item
Planned Trial Duration (PLNTRDUR)
CL Item
Protocol Risk Assessment (PROTRSK)
CL Item
Planned Treatment Duration (PTRTDUR)
CL Item
PubMed ID for Citation Used in Study (PUBMEDID)
CL Item
Trial is Randomized (RANDOM)
CL Item
Randomization Quotient (RANDQT)
CL Item
Rare Disease Indicator (RDIND)
CL Item
Registry Identifier (REGID)
CL Item
Resubmission Letter (RESUBLTR)
CL Item
Relapse Criteria (RLPSCRIT)
CL Item
Route of Administration (ROUTE)
CL Item
Retained Biospecimen Description (RTSPCDES)
CL Item
Request for XML Copy of Study Indicator (RXMLCIND)
CL Item
Stable Disease Minimum Duration (SDMDUR)
CL Item
SDTM IG Version; SDTM Implementation Guide Version (SDTIGVER)
CL Item
SDTM Version (SDTMVER)
CL Item
Secure Delivery XML Required Indicator (SDXMLIND)
CL Item
Study End Date (SENDTC)
CL Item
Severity Criteria (SEVCRIT)
CL Item
Sex of Participants (SEXPOP)
CL Item
Clinical Study Sponsor; Sponsor; Study Sponsor (SPONSOR)
CL Item
SUSAR Reporting to EVCTM Indicator (SREVIND)
CL Item
SUSAR Reporting to NCA Indicator (SRNCAIND)
CL Item
Single Site EU State Trial Indicator (SSEUTIND)
CL Item
Study Start Date (SSTDTC)
CL Item
Substudy Details (SSTDYDTL)
CL Item
Substudy Planned Indicator (SSTDYIND)
CL Item
Study Stop Rules (STOPRULE)
CL Item
Stratification Factor (STRATFCT)
CL Item
Study Type (STYPE)
CL Item
Trial Blinding Schema (TBLIND)
CL Item
Control Type (TCNTRL)
CL Item
Diagnosis Group (TDIGRP)
CL Item
Therapeutic Area (THERAREA)
CL Item
Trial Intent Type (TINDTP)
CL Item
Trial Title (TITLE)
CL Item
Trial Phase Classification (TPHASE)
CL Item
Target Follow-Up Duration (TRGFUDUR)
CL Item
Investigational Therapy or Treatment (TRT)
CL Item
Trial Scope; Trial Type (TTYPE)
CL Item
URL Related to Study (URLSTDY)
CL Item
URL Related to Study Description (URLSTDYD)
Item
Trial Summary Parameter
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
TSPARM (SDTMIG 3.3)
C49691 (NCIt V19.10d)
PARM
Code List
Trial Summary Parameter
CL Item
Actual Number of Subjects (Actual Number of Subjects)
CL Item
Adaptive Design (Adaptive Design)
CL Item
Added on to Existing Treatments (Added on to Existing Treatments)
CL Item
Additional Outcome Measure (Additional Outcome Measure)
CL Item
Biospecimen Retention Contains DNA (Biospecimen Retention Contains DNA)
CL Item
Blinded Status SDTM Dataset Generation; Blinded Status at SDTM Dataset Generation (Blinded Status SDTM Dataset Generation)
CL Item
CDISC Therapeutic Area User Guide (CDISC Therapeutic Area User Guide)
CL Item
Citation Used in Study (Citation Used in Study)
CL Item
Clinical Study Report Archive Date (Clinical Study Report Archive Date)
CL Item
Clinical Study Sponsor; Sponsor; Study Sponsor (Clinical Study Sponsor)
CL Item
Commercial Sponsor Status (Commercial Sponsor Status)
CL Item
Comparative Treatment Name (Comparative Treatment Name)
CL Item
Confirmed Response Minimum Duration (Confirmed Response Minimum Duration)
CL Item
Control Type (Control Type)
CL Item
Country of Manufacture (Country of Manufacture)
CL Item
Current Therapy or Treatment (Current Therapy or Treatment)
CL Item
Data Cutoff Date (Data Cutoff Date)
CL Item
Data Cutoff Description (Data Cutoff Description)
CL Item
Data Monitoring Committee Indicator (Data Monitoring Committee Indicator)
CL Item
Delayed Graft Function Diagnostic Criteria; Delayed Graft Function Dx Criteria (Delayed Graft Function Dx Criteria)
CL Item
Diagnosis Group (Diagnosis Group)
CL Item
Diagnostic Criteria (Diagnostic Criteria)
CL Item
Dose Form (Dose Form)
CL Item
Dose Level; Dose per Administration (Dose per Administration)
CL Item
Dose Regimen (Dose Regimen)
CL Item
Dose Units (Dose Units)
CL Item
Dosing Frequency (Dosing Frequency)
CL Item
ECG Continuous Monitoring (ECG Continuous Monitoring)
CL Item
ECG Planned Primary Lead (ECG Planned Primary Lead)
CL Item
ECG Read Method (ECG Read Method)
CL Item
ECG Reading Blinded (ECG Reading Blinded)
CL Item
ECG Replicates at Baseline (ECG Replicates at Baseline)
CL Item
ECG Replicates On-Treatment (ECG Replicates On-Treatment)
CL Item
ECG Twave Algorithm (ECG Twave Algorithm)
CL Item
ECG Used Same Lead (ECG Used Same Lead)
CL Item
EMA Decision Number for PIP (EMA Decision Number for PIP)
CL Item
Email Address for XML File (Email Address for XML File)
CL Item
EudraCT Resubmission Indicator (EudraCT Resubmission Indicator)
CL Item
EudraVigilance Sender ID (EudraVigilance Sender ID)
CL Item
EudraVigilance Sender Organization (EudraVigilance Sender Organization)
CL Item
Expanded Access Record NCT Number (Expanded Access Record NCT Number)
CL Item
Expanded Access Status (Expanded Access Status)
CL Item
Exploratory Outcome Measure (Exploratory Outcome Measure)
CL Item
Extension Trial Indicator (Extension Trial Indicator)
CL Item
FDA Technical Specification (FDA Technical Specification)
CL Item
FDA-Regulated Device Study Indicator (FDA-Regulated Device Study Indicator)
CL Item
FDA-Regulated Drug Study Indicator (FDA-Regulated Drug Study Indicator)
CL Item
Healthy Subject Indicator (Healthy Subject Indicator)
CL Item
Intervention Model (Intervention Model)
CL Item
Intervention Type (Intervention Type)
CL Item
Investigational Therapy or Treatment (Investigational Therapy or Treatment)
CL Item
Multiple Site EU State Trial Indicator (Multiple Site EU State Trial Indicator)
CL Item
Number of Groups/Cohorts (Number of Groups/Cohorts)
CL Item
Number of Trial Sites EU State (Number of Trial Sites EU State)
CL Item
Obs Study Population Description (Obs Study Population Description)
CL Item
Obs Study Sampling Method Description (Obs Study Sampling Method Description)
CL Item
Observational Model (Observational Model)
CL Item
Observational Study Sampling Method (Observational Study Sampling Method)
CL Item
Observational Time Perspective (Observational Time Perspective)
CL Item
Pediatric Investigation Plan Indicator (Pediatric Investigation Plan Indicator)
CL Item
Pediatric Postmarket Study Indicator (Pediatric Postmarket Study Indicator)
CL Item
Pediatric Study Indicator (Pediatric Study Indicator)
CL Item
Pharmacologic Class (Pharmacologic Class)
CL Item
Planned Country of Investigational Sites (Planned Country of Investigational Sites)
CL Item
Planned Maximum Age of Subjects (Planned Maximum Age of Subjects)
CL Item
Planned Minimum Age of Subjects (Planned Minimum Age of Subjects)
CL Item
Planned Number of Arms (Planned Number of Arms)
CL Item
Anticipated Enrollment; Planned Enrollment; Planned Number of Subjects; Target Enrollment (Planned Number of Subjects)
CL Item
Planned Treatment Duration (Planned Treatment Duration)
CL Item
Planned Trial Duration (Planned Trial Duration)
CL Item
Post Authorization Safety Study Ind (Post Authorization Safety Study Ind)
CL Item
Primary Outcome Measure (Primary Outcome Measure)
CL Item
Protocol Keyword (Protocol Keyword)
CL Item
Protocol Risk Assessment (Protocol Risk Assessment)
CL Item
PubMed ID for Citation Used in Study (PubMed ID for Citation Used in Study)
CL Item
Randomization Quotient (Randomization Quotient)
CL Item
Rare Disease Indicator (Rare Disease Indicator)
CL Item
Registry Identifier (Registry Identifier)
CL Item
Relapse Criteria (Relapse Criteria)
CL Item
Request for XML Copy of Study Indicator (Request for XML Copy of Study Indicator)
CL Item
Resubmission Letter (Resubmission Letter)
CL Item
Retained Biospecimen Description (Retained Biospecimen Description)
CL Item
Route of Administration (Route of Administration)
CL Item
SDTM IG Version; SDTM Implementation Guide Version (SDTM IG Version)
CL Item
SDTM Version (SDTM Version)
CL Item
Secondary Outcome Measure (Secondary Outcome Measure)
CL Item
Secure Delivery XML Required Indicator (Secure Delivery XML Required Indicator)
CL Item
Severity Criteria (Severity Criteria)
CL Item
Sex of Participants (Sex of Participants)
CL Item
Single Site EU State Trial Indicator (Single Site EU State Trial Indicator)
CL Item
Stable Disease Minimum Duration (Stable Disease Minimum Duration)
CL Item
Stratification Factor (Stratification Factor)
CL Item
Study End Date (Study End Date)
CL Item
Study Start Date (Study Start Date)
CL Item
Study Stop Rules (Study Stop Rules)
CL Item
Study Type (Study Type)
CL Item
Substudy Details (Substudy Details)
CL Item
Substudy Planned Indicator (Substudy Planned Indicator)
CL Item
SUSAR Reporting to EVCTM Indicator (SUSAR Reporting to EVCTM Indicator)
CL Item
SUSAR Reporting to NCA Indicator (SUSAR Reporting to NCA Indicator)
CL Item
Target Follow-Up Duration (Target Follow-Up Duration)
CL Item
Therapeutic Area (Therapeutic Area)
CL Item
Trial Blinding Schema (Trial Blinding Schema)
CL Item
Trial Disease/Condition Indication (Trial Disease/Condition Indication)
CL Item
Trial Exploratory Objective (Trial Exploratory Objective)
CL Item
Trial Intent Type (Trial Intent Type)
CL Item
Trial is Randomized (Trial is Randomized)
CL Item
Trial Length (Trial Length)
CL Item
Trial Phase Classification (Trial Phase Classification)
CL Item
Trial Primary Objective (Trial Primary Objective)
CL Item
Trial Secondary Objective (Trial Secondary Objective)
CL Item
Trial Title (Trial Title)
CL Item
Trial Scope; Trial Type (Trial Type)
CL Item
URL Related to Study (URL Related to Study)
CL Item
URL Related to Study Description (URL Related to Study Description)
VAL
Item
Parameter Value
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
TSVAL (SDTMIG 3.3)
C83447 (NCIt V19.10d)
Item
Parameter Null Flavor
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
C3897207 (UMLS CUI [1,4])
TSVALNF (SDTMIG 3.3)
C117459 (NCIt V19.10d)
VALNF
Code List
Parameter Null Flavor
CL Item
No information (NI)
(Comment:en)
CL Item
Invalid (INV)
(Comment:en)
CL Item
Invalid: Other (OTH)
(Comment:en)
CL Item
Invalid: Other: Positive infinity (PINF)
(Comment:en)
CL Item
Invalid: Other: Negative infinity (NINF)
(Comment:en)
CL Item
Invalid: Unencoded (UNC)
(Comment:en)
CL Item
Invalid: Derived (DER)
(Comment:en)
CL Item
Unknown (UNK)
(Comment:en)
CL Item
Asked but unknown (ASKU)
(Comment:en)
CL Item
Asked but unknown: Temporarily unavailable (NAV)
(Comment:en)
CL Item
Unknown: Not asked (NASK)
(Comment:en)
CL Item
Unknown: Quantity sufficient (QS)
(Comment:en)
CL Item
Unknown: Trace (TRC)
(Comment:en)
CL Item
Masked (MSK)
(Comment:en)
CL Item
Not applicable (NA)
(Comment:en)
VALCD
Item
Parameter Value Code
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
TSVALCD (SDTMIG 3.3)
C117458 (NCIt V19.10d)
VCDREF
Item
Name of the Reference Terminology
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,3])
C0034925 (UMLS CUI [1,4])
C0028275 (UMLS CUI [1,5])
TSVCDREF (SDTMIG 3.3)
C117460 (NCIt V19.10d)
VCDVER
Item
Version of the Reference Terminology
text
C0008976 (UMLS CUI [1,1])
C0242482 (UMLS CUI [1,2])
C0333052 (UMLS CUI [1,3])
C0034925 (UMLS CUI [1,4])
C0028275 (UMLS CUI [1,5])
TSVCDVER (SDTMIG 3.3)
C117461 (NCIt V19.10d)
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