,
Gayatri G [aut],
Kangjie Zhang [aut],
Pooja Kumari [aut],
Stefan Bundfuss [aut] ,
Zelos Zhu [aut],
Sadchla Mascary [aut],
Vladyslav Shuliar [aut] ,
Vinh Nguyen [aut]| Title: | SDTM Test Data for the 'Pharmaverse' Family of Packages |
|---|---|
| Description: | A set of Study Data Tabulation Model (SDTM) datasets from the Clinical Data Interchange Standards Consortium (CDISC) pilot project used for testing and developing Analysis Data Model (ADaM) datasets inside the pharmaverse family of packages. SDTM dataset specifications are described in the CDISC SDTM implementation guide, accessible by creating a free account on <https://www.cdisc.org/>. |
| Authors: | Edoardo Mancini [aut, cre] ,
Gayatri G [aut],
Kangjie Zhang [aut],
Pooja Kumari [aut],
Stefan Bundfuss [aut] ,
Zelos Zhu [aut],
Sadchla Mascary [aut],
Vladyslav Shuliar [aut] ,
Vinh Nguyen [aut] |
| Maintainer: | Edoardo Mancini <[email protected]> |
| License: | Apache License (>= 2.0) |
| Version: | 1.2.0 |
| Built: | 2025-01-23 13:26:32 UTC |
| Source: | https://github.com/pharmaverse/pharmaversesdtm |
An updated SDTM AE dataset that uses the CDISC pilot project
aeae
A data frame with 35 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Sponsor-Defined Identifier
Reported Term for the Adverse Event
Lowest Level Term
Lowest Level Term Code
Dictionary-Derived Term
Preferred Term Code
High Level Term
High Level Term Code
High Level Group Term
High Level Group Term Code
Body System or Organ Class
Body System or Organ Class Code
Primary System Organ Class
Primary System Organ Class Code
Severity/Intensity
Serious Event
Action Taken with Study Treatment
Causality
Outcome of Adverse Event
Involves Cancer
Congenital Anomaly or Birth Defect
Persist or Signif Disability/Incapacity
Results in Death
Requires or Prolongs Hospitalization
Is Life Threatening
Occurred with Overdose
Date/Time of Collection
Start Date/Time of Adverse Event
End Date/Time of Adverse Event
Study Day of Start of Adverse Event
Study Day of End of Adverse Event
Adverse Events
An updated SDTM AE dataset that uses the CDISC pilot project
Gopi Vegesna
Access the source of the Adverse Events dataset.
An example Adverse Events SDTM dataset with ophthalmology-specific variable AELAT
ae_ophthaae_ophtha
A data frame with 37 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Sponsor-Defined Identifier
Reported Term for the Adverse Event
Lowest Level Term
Lowest Level Term Code
Dictionary-Derived Term
Preferred Term Code
High Level Term
High Level Term Code
High Level Group Term
High Level Group Term Code
Body System or Organ Class
Body System or Organ Class Code
Primary System Organ Class
Primary System Organ Class Code
Severity/Intensity
Serious Event
Action Taken with Study Treatment
Causality
Outcome of Adverse Event
Involves Cancer
Congenital Anomaly or Birth Defect
Persist or Signif Disability/Incapacity
Results in Death
Requires or Prolongs Hospitalization
Is Life Threatening
Occurred with Overdose
Date/Time of Collection
Start Date/Time of Adverse Event
End Date/Time of Adverse Event
Study Day of Start of Adverse Event
Study Day of End of Adverse Event
Laterality
Location
Adverse Events for Ophthalmology
An example Adverse Events SDTM dataset with ophthalmology-specific variable AELAT
Constructed using ae from the pharmaversesdtm package
An example SDTM CE dataset for vaccine studies
ce_vaccinece_vaccine
A data frame with 29 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Link ID
Link Group ID
Reported Term for the Clinical Event
Dictionary-Derived Term
Laterality of Location of Clinical Event
Location of Clinical Event
Category for Clinical Event
Subcategory for Clinical Event
Clinical Event Pre-Specified
Clinical Event Occurrence
Severity/Intensity
Causality
Outcome of Clinical Event
Epoch
Date/Time of Event Collection
Start Date/Time of Clinical Event
End Date/Time of Clinical Event
Duration of Clinical Event
Planned Time Point Name
Planned Time Point Number
Time Point Reference
Date/Time of Reference Time Point
Evaluation Interval Text
Completion Status
Reason Clinical Event Not Collected
Clinical Events for Vaccine
An example SDTM CE dataset for vaccine studies
Constructed by admiralvaccine developers
A SDTM CM dataset from the CDISC pilot project
cmcm
A data frame with 22 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Sponsor-Defined Identifier
Reported Name of Drug, Med, or Therapy
Standardized Medication Name
Indication
Medication Class
Dose per Administration
Dose Units
Dosing Frequency per Interval
Route of Administration
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Collection
Start Date/Time of Medication
End Date/Time of Medication
Study Day of Start of Medication
Study Day of End of Medication
undocumented field
Concomitant Medication
A SDTM CM dataset from the CDISC pilot project
Access the source of the Concomitant Medication dataset.
A SDTM DM dataset from the CDISC pilot project
dmdm
A data frame with 25 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Demography
A SDTM DM dataset from the CDISC pilot project
Access the source of the Demography dataset.
An updated SDTM DM dataset with pediatric patients
dm_pedsdm_peds
A data frame with 26 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Date/Time of Birth
Demographic Dataset-pediatrics
An updated SDTM DM dataset with pediatric patients
Constructed by admiralpeds developers
An example SDTM DM dataset for vaccine studies
dm_vaccinedm_vaccine
A data frame with 28 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Subject Identifier for the Study
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of Informed Consent
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Study Site Identifier
Investigator Identifier
Investigator Name
Date/Time of Birth
Age
Age Units
Sex
Race
Ethnicity
Planned Arm Code
Description of Planned Arm
Actual Arm Code
Description of Actual Arm
Country
Date/Time of Collection
Study Day of Collection
Demographics for Vaccine
An example SDTM DM dataset for vaccine studies
Constructed by admiralvaccine developers
An updated SDTM DS dataset that uses the CDISC pilot project
dsds
A data frame with 13 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Sponsor-Defined Identifier
Reported Term for the Disposition Event
Standardized Disposition Term
Category for Disposition Event
Visit Number
Visit Name
Date/Time of Collection
Start Date/Time of Disposition Event
Study Day of Start of Disposition Event
Disposition
An updated SDTM DS dataset that uses the CDISC pilot project
Gopi Vegesna
Access the source of the Disposition dataset.
An example of standard SDTM EG dataset to be used in deriving ADEG dataset
egeg
A data frame with 23 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Test Code
Test Name
Original Result
Original Units
Standard Character Result
Standard Numeric Result
Standard Units
Completion Status
Location of Vital Signs Measurement
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Measurements
Study Day of Vital Signs
Planned Time Point Number
Time Point Number
Planned Elapsed Time from Time Point Ref
Time Point Reference
Electrocardiogram
An example of standard SDTM EG dataset to be used in deriving ADEG dataset
Generated dataset.
A SDTM EX dataset from the CDISC pilot project
exex
A data frame with 17 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Name of Actual Treatment
Dose per Administration
Dose Units
Dose Form
Dosing Frequency per Interval
Route of Administration
Visit Number
Visit Name
Planned Study Day of Visit
Start Date/Time of Treatment
End Date/Time of Treatment
Study Day of Start of Treatment
Study Day of End of Treatment
Exposure
A SDTM EX dataset from the CDISC pilot project
Access the source of the Exposure dataset.
An example Exposure SDTM dataset with ophthalmology-specific variables such as EXLOC and EXLAT
ex_ophthaex_ophtha
A data frame with 19 columns:
Unique Subject Identifier
Study Identifier
Domain Abbreviation
Sequence Number
Name of Actual Treatment
Dose per Administration
Dose Units
Dose Form
Dose Frequency per Interval
Route of Administration
Location of Dose Administration
Laterality
Visit Number
Visit Name
Planned Study Day of Visit
Start Date/Time of Treatment
End Date/Time of Treatment
Study Day of Start of Treatment
Study Day of End of Treatment
Exposure for Ophthalmology
An example Exposure SDTM dataset with ophthalmology-specific variables such as EXLOC and EXLAT
Constructed using ex from the pharmaversesdtm package
An example SDTM EX dataset for vaccine studies
ex_vaccineex_vaccine
A data frame with 21 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Link Group ID
Link ID
Name of Actual Treatment
Category of Treatment
Dose per Administration
Dose Units
Dose Form
Route of Administration
Location of Dose Administration
Laterality
Visit Number
Visit Name
Epoch
undocumented field
Start Date/Time of Treatment
End Date/Time of Treatment
undocumented field
Exposures for Vaccine
An example SDTM EX dataset for vaccine studies
Constructed by admiralvaccine developers
An example SDTM FACE for vaccine studies
face_vaccineface_vaccine
A data frame with 30 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Link Group ID
Laterality
Link ID
Location of the Finding About
Findings About Test Short Name
Findings About Test Name
Object of the Observation
Category for Findings About
Subcategory for Findings About
Evaluator
Result or Finding in Original Units
Original Units
Epoch
Date/Time of Collection
Study Day of Collection
Planned Time Point Name
Planned Time Point Number
Time Point Reference
Date/Time of Reference Time Point
Evaluation Interval
Evaluation Interval Text
Completion Status
Reason Not Performed
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Findings About Clinical Events for Vaccine
An example SDTM FACE for vaccine studies
Constructed by admiralvaccine developers
get_terms_fun parameter of
admiral::create_query_data()
An example function as expected by the get_terms_fun parameter of
admiral::create_query_data()
get_terms(basket_select, version, keep_id, temp_env)get_terms(basket_select, version, keep_id, temp_env)
basket_select |
A basket_select object defining the terms |
version |
MedDRA version |
keep_id |
Should |
temp_env |
Temporary environment |
An example SDTM IS for vaccine studies
is_vaccineis_vaccine
A data frame with 24 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Immunogenicity Test/Exam Short Name
Immunogenicity Test or Exam Name
Category for Immunogenicity Test
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Completion Status
Reason Not Done
Vendor Name
Specimen Type
Method of Test or Examination
Baseline Flag
Lower Limit of Quantitation
Visit Number
Epoch
Date/Time of Collection
Study Day of Collection
Upper Limit of Quantitation
Immunogenicity Specimen Assessments for Vaccine
An example SDTM IS for vaccine studies
Constructed by admiralvaccine developers
An updated SDTM LB dataset that uses data from the CDISC pilot project
lblb
A data frame with 23 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Lab Test or Examination Short Name
Lab Test or Examination Name
Category for Lab Test
Result or Finding in Original Units
Original Units
Reference Range Lower Limit in Orig Unit
Reference Range Upper Limit in Orig Unit
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Reference Range Lower Limit-Std Units
Reference Range Upper Limit-Std Units
Reference Range Indicator
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Specimen Collection
Study Day of Specimen Collection
Laboratory Measurements
An updated SDTM LB dataset that uses data from the CDISC pilot project
Annie Yang
Access the source of the Laboratory Measurements dataset.
An updated SDTM MH dataset that uses data from the CDISC pilot project
mhmh
A data frame with 28 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Sponsor-Defined Identifier
Reported Term for the Medical History
Lowest Level Term
Dictionary-Derived Term
High Level Term
High Level Group Term
Category for Medical History
Body System or Organ Class
Severity/Intensity
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of History Collection
Start Date/Time of Medical History Event
Study Day of History Collection
End Date/Time of Medical History Event
Medical History Event Pre-Specified
Medical History Occurrence
Start Relative to Reference Time Point
End Relative to Reference Time Point
Start Reference Time Point
End Reference Time Point
End Relative to Reference Period
Completion Status
Medical History
An updated SDTM MH dataset that uses data from the CDISC pilot project
Annie Yang
Access the source of the Medical History dataset.
A SDTM OE dataset simulated by Ophthalmology team
oe_ophthaoe_ophtha
A data frame with 25 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Category for Ophthalmic Test or Exam
Subcategory for Ophthalmic Test or Exam
Date/Time of Collection
Visit Name
Visit Number
Planned Study Day of Visit
Numeric Result/Finding in Standard Units
Character Result/Finding in Std Format
Result or Finding in Original Units
Name of Ophthalmic Test or Examination
Short Name of Ophthalmic Test or Exam
Ophthalmic Test or Exam Detail
Laterality
Location Used for the Measurement
Study Day of Visit/Collection/Exam
Method of Test or Examination
Original Units
Standard Units
Completion Status
Planned Time Point Name
Planned Time Point Number
Ophthalmic Examinations for Ophthalmology
A SDTM OE dataset simulated by Ophthalmology team
Gordon Miller
Generated dataset.
A SDTM PC dataset simulated by Antonio Rodriguez Contesti
pcpc
A data frame with 20 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Pharmacokinetic Test Short Name
Pharmacokinetic Test Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Vendor Name
Specimen Material Type
Lower Limit of Quantitation
Visit Name
Visit Number
Date/Time of Specimen Collection
Actual Study Day of Specimen Collection
Planned Time Point Name
Planned Time Point Number
Pharmacokinetic Concentrations
A SDTM PC dataset simulated by Antonio Rodriguez Contesti
Antonio Rodriguez Contesti
Access the source of the Pharmacokinetic Concentrations dataset.
A SDTM PP dataset simulated by Antonio Rodriguez Contesti
pppp
A data frame with 14 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Parameter Short Name
Parameter Name
Parameter Category
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Specimen Material Type
Date/Time of Reference Point
Pharmacokinetic Parameters
A SDTM PP dataset simulated by Antonio Rodriguez Contesti
Antonio Rodriguez Contesti
Access the source of the Pharmacokinetic Parameters dataset.
An example Questionnaires SDTM dataset with ophthalmology-specific questionnaire of NEI VFQ-25
qs_ophthaqs_ophtha
A data frame with 20 columns:
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
Questionnaire for Ophthalmology
An example Questionnaires SDTM dataset with ophthalmology-specific questionnaire of NEI VFQ-25
Constructed using qs from the pharmaversesdtm package
A SDTM RS dataset simulated by Gopi Vegesna
rs_oncors_onco
A data frame with 19 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Link Group
Response Assessment Short Name
Response Assessment Name
Category for Response Assessment
Response Assessment Original Result
Response Assessment Result in Std Format
Completion Status
Reason Response Assessment Not Performed
Evaluator
Evaluator Identifier
Accepted Record Flag
Visit Number
Visit Name
Date/Time of Response Assessment
Study Day of Response Assessment
Disease Response for Oncology
A SDTM RS dataset simulated by Gopi Vegesna
Gopi Vegesna
Access the source of the Disease Response for Oncology dataset.
A SDTM RS dataset using GCIG criteria. The dataset contains just a few patients. It is intended for vignettes and examples of ADaM dataset creation.
rs_onco_ca125rs_onco_ca125
A data frame with 13 columns:
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
Disease Response (GCIG)
A SDTM RS dataset using GCIG criteria. The dataset contains just a few patients. It is intended for vignettes and examples of ADaM dataset creation.
Vinh Nguyen
Generated dataset (rs_supprs_onco_ca125.R)
A SDTM RS dataset using IMWG criteria intended for examples of ADaM dataset creation
rs_onco_imwgrs_onco_imwg
A data frame with 17 columns:
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
Disease Response (IMWG)
A SDTM RS dataset using IMWG criteria intended for examples of ADaM dataset creation
Vinh Nguyen
Derived from tr_onco_recist
A SDTM RS dataset using iRECIST intended for examples of ADaM dataset creation
rs_onco_irecistrs_onco_irecist
A data frame with 19 columns:
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
Disease Response (iRECIST) for Oncology
A SDTM RS dataset using iRECIST intended for examples of ADaM dataset creation
Rohan Thampi
Generated dataset.
A SDTM RS dataset using RECIST 1.1 intended for examples of ADaM dataset creation
rs_onco_recistrs_onco_recist
A data frame with 14 columns:
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
Disease Response (RECIST 1.1) for Oncology
A SDTM RS dataset using RECIST 1.1 intended for examples of ADaM dataset creation
Stefan Bundfuss
Generated dataset.
A SDTM SC dataset simulated by Ophthalmology team
sc_ophthasc_ophtha
A data frame with 12 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Subject Characteristic Short Name
Subject Characteristic
Category for Subject Characteristic
Result or Finding in Original Units
Character Result/Finding in Std Format
Epoch
Date/Time of Collection
Study Day of Examination
Subject Characteristic for Ophthalmology
A SDTM SC dataset simulated by Ophthalmology team
Gordon Miller
Generated dataset.
An example SDG dataset
sdg_dbsdg_db
A data frame with 5 columns:
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
SDG
An example SDG dataset
Access the source of the SDG dataset.
An example SMQ dataset
smq_dbsmq_db
A data frame with 6 columns:
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
Standardized MedDRA Queries
An example SMQ dataset
Generated dataset.
A SDTM SUPPAE dataset from the CDISC pilot project
suppaesuppae
A data frame with 10 columns:
Study Identifier
Related Domain Abbreviation
Unique Subject Identifier
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Qualifier Variable Label
Data Value
Origin
Evaluator
Supplemental Adverse Events
A SDTM SUPPAE dataset from the CDISC pilot project
Access the source of the Supplemental Adverse Events dataset.
An example SDTM SUPPCE for vaccine studies
suppce_vaccinesuppce_vaccine
A data frame with 9 columns:
Study Identifier
Unique Subject Identifier
Related Domain Abbreviation
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Data Value
Qualifier Variable Label
Origin
Supplemental Qualifiers for Clinical Events for Vaccine
An example SDTM SUPPCE for vaccine studies
Constructed by admiralvaccine developers
A SDTM SUPPDM dataset from the CDISC pilot project
suppdmsuppdm
A data frame with 10 columns:
Study Identifier
Related Domain Abbreviation
Unique Subject Identifier
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Qualifier Variable Label
Data Value
Origin
Evaluator
Supplemental Demography
A SDTM SUPPDM dataset from the CDISC pilot project
Generated dataset.
An example SDTM SUPPDM dataset for vaccine studies
suppdm_vaccinesuppdm_vaccine
A data frame with 9 columns:
Study Identifier
Unique Subject Identifier
Related Domain Abbreviation
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Data Value
Qualifier Variable Label
Origin
Supplemental Qualifiers for Demographics for Vaccine
An example SDTM SUPPDM dataset for vaccine studies
Constructed by admiralvaccine developers
A SDTM SUPPDS dataset from the CDISC pilot project
suppdssuppds
A data frame with 9 columns:
Study Identifier
Related Domain Abbreviation
Unique Subject Identifier
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Qualifier Variable Label
Data Value
Origin
Supplemental Disposition
A SDTM SUPPDS dataset from the CDISC pilot project
Access the source of the Supplemental Disposition dataset.
An example SDTM SUPPEX dataset for vaccine studies
suppex_vaccinesuppex_vaccine
A data frame with 9 columns:
Study Identifier
Unique Subject Identifier
Related Domain Abbreviation
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Data Value
Qualifier Variable Label
Origin
Supplemental Qualifiers for Exposures for Vaccine
An example SDTM SUPPEX dataset for vaccine studies
Constructed by admiralvaccine developers
An example SDTM SUPPFACE dataset for vaccine studies
suppface_vaccinesuppface_vaccine
A data frame with 9 columns:
Study Identifier
Unique Subject Identifier
Related Domain Abbreviation
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Data Value
Qualifier Variable Label
Origin
Supplemental Qualifiers for Findings About for Clinical Events for Vaccine
An example SDTM SUPPFACE dataset for vaccine studies
Constructed by admiralvaccine developers
An example SDTM SUPPIS dataset for vaccine studies
suppis_vaccinesuppis_vaccine
A data frame with 10 columns:
Study Identifier
Related Domain Abbreviation
Unique Subject Identifier
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Qualifier Variable Label
Data Value
Origin
Evaluator
Supplemental Qualifiers for Immunogenicity Specimen Assessments for Vaccine
An example SDTM SUPPIS dataset for vaccine studies
Constructed by admiralpeds developers
A SDTM supplemental RS dataset using GCIG criteria. It is intended to be used together with rs_onco_ca125.
supprs_onco_ca125supprs_onco_ca125
A data frame with 9 columns:
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
Supplemental Qualifiers for RS_ONCO_CA125
A SDTM supplemental RS dataset using GCIG criteria. It is intended to be used together with rs_onco_ca125.
Vinh Nguyen
Generated dataset (rs_supprs_onco_ca125.R)
A SDTM supplemental RS dataset using IMWG criteria intended to be used with rs_onco_imwg
supprs_onco_imwgsupprs_onco_imwg
A data frame with 9 columns:
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
Supplemental Qualifiers for RS_ONCO_IMWG
A SDTM supplemental RS dataset using IMWG criteria intended to be used with rs_onco_imwg
Vinh Nguyen
Access the source of the Supplemental Qualifiers for RS_ONCO_IMWG dataset.
A SDTM SUPPTR dataset simulated by Gopi Vegesna
supptr_oncosupptr_onco
A data frame with 9 columns:
Study Identifier
Related Domain Abbreviation
Unique Subject Identifier
Identifying Variable
Identifying Variable Value
Qualifier Variable Name
Qualifier Variable Label
Data Value
Origin
Supplemental Tumor Results for Oncology
A SDTM SUPPTR dataset simulated by Gopi Vegesna
Gopi Vegesna
Access the source of the Supplemental Tumor Results for Oncology dataset.
A SDTM SV dataset from the CDISC pilot project with corrected duplicate observation
svsv
A data frame with 8 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Visit Number
Visit Name
Planned Study Day of Visit
Start Date/Time of Visit
End Date/Time of Visit
Subject Visits
A SDTM SV dataset from the CDISC pilot project with corrected duplicate observation
Constructed by admiralvaccine developers
A SDTM TR dataset simulated by Gopi Vegesna
tr_oncotr_onco
A data frame with 24 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Group ID
Link Group
Link ID
Tumor Assessment Short Name
Tumor Assessment Test Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Completion Status
Reason Tumor Measurement Not Performed
Method used to Identify the Tumor
Evaluator
Evaluator Identifier
Accepted Record Flag
Visit Number
Visit Name
Date/Time of Tumor Measurement
Study Day of Tumor Measurement
Tumor Results for Oncology
A SDTM TR dataset simulated by Gopi Vegesna
Gopi Vegesna
Generated dataset.
A SDTM TR dataset using RECIST 1.1 intended for examples of ADaM dataset creation
tr_onco_recisttr_onco_recist
A data frame with 19 columns:
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
Tumor Results (RECIST 1.1) for Oncology
A SDTM TR dataset using RECIST 1.1 intended for examples of ADaM dataset creation
Stefan Bundfuss
Generated dataset.
A SDTM TS dataset from the CDISC pilot project
tsts
A data frame with 6 columns:
Study Identifier
Domain Abbreviation
Sequence Number
Trial Summary Parameter Short Name
Trial Summary Parameter
Parameter Value
Trial Design
A SDTM TS dataset from the CDISC pilot project
Access the source of the Trial Design dataset.
A SDTM TU dataset simulated by Gopi Vegesna
tu_oncotu_onco
A data frame with 18 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Link ID
Tumor Identification Short Name
Tumor Identification Test Name
Tumor Identification Result
Tumor Identification Result Std. Format
Location of the Tumor
Method of Identification
Evaluator
Evaluator Identifier
Accepted Record Flag
Visit Number
Visit Name
Date/Time of Tumor Identification
Study Day of Tumor Identification
Tumor Identification for Oncology
A SDTM TU dataset simulated by Gopi Vegesna
Gopi Vegesna
Generated dataset.
A SDTM TU dataset using RECIST 1.1 intended for examples of ADaM dataset creation
tu_onco_recisttu_onco_recist
A data frame with 16 columns:
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
undocumented field
Tumor Identification (RECIST 1.1) for Oncology
A SDTM TU dataset using RECIST 1.1 intended for examples of ADaM dataset creation
Stefan Bundfuss
Generated dataset.
A SDTM VS dataset from the CDISC pilot project
vsvs
A data frame with 24 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Vital Signs Test Short Name
Vital Signs Test Name
Vital Signs Position of Subject
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Completion Status
Location of Vital Signs Measurement
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Measurements
Study Day of Vital Signs
Planned Time Point Name
Planned Time Point Number
Planned Elapsed Time from Time Point Ref
Time Point Reference
Vital Signs
A SDTM VS dataset from the CDISC pilot project
Generated dataset.
An updated SDTM VS dataset with anthropometric measurements for pediatric patients
vs_pedsvs_peds
A data frame with 26 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Vital Signs Test Short Name
Vital Signs Test Name
Vital Signs Position of Subject
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Completion Status
Location of Vital Signs Measurement
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Measurements
Study Day of Vital Signs
Planned Time Point Name
Planned Time Point Number
Planned Elapsed Time from Time Point Ref
Time Point Reference
Evaluator
Epoch
Vital signs Dataset-pediatrics
An updated SDTM VS dataset with anthropometric measurements for pediatric patients
Constructed by admiralpeds developers
An example SDTM VS dataset for vaccine studies
vs_vaccinevs_vaccine
A data frame with 23 columns:
Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sequence Number
Link ID
Link Group ID
Vital Signs Test Short Name
Vital Signs Test Name
Category for Vital Signs
Subcategory for Vital Signs
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Evaluator
Location of Vital Signs Measurement
Epoch
Date/Time of Measurements
Study Day of Vital Signs
Planned Time Point Name
Planned Time Point Number
Time Point Reference
Vital Signs for Vaccine
An example SDTM VS dataset for vaccine studies
Constructed by admiralvaccine developers