{
  "sdtms-specs": [
    {
      "name": "ae",
      "label": "Adverse Events",
      "description": "An updated SDTM AE dataset that uses the CDISC pilot project",
      "source": "https://github.com/pharmaverse/pharmaversesdtm/blob/main/data/ae.rda",
      "author": "Gopi Vegesna"
    },
    {
      "name": "ae_ophtha",
      "label": "Adverse Events for Ophthalmology",
      "description": "An example Adverse Events SDTM dataset with ophthalmology-specific variable `AELAT`",
      "source": "Constructed using ae from the {pharmaversesdtm} package"
    },
    {
      "name": "cm",
      "label": "Concomitant Medication",
      "description": "A SDTM CM dataset from the CDISC pilot project",
      "source": "https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/cm.xpt?raw=true"
    },
    {
      "name": "dm",
      "label": "Demography",
      "description": "A SDTM DM dataset from the CDISC pilot project",
      "source": "https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/dm.xpt?raw=true"
    },
    {
      "name": "ds",
      "label": "Disposition",
      "description": "An updated SDTM DS dataset that uses the CDISC pilot project",
      "source": "https://github.com/pharmaverse/pharmaversesdtm/blob/main/data/ds.rda",
      "author": "Gopi Vegesna"
    },
    {
      "name": "eg",
      "label": "Electrocardiogram",
      "description": "An example of standard SDTM EG dataset to be used in deriving ADEG dataset",
      "source": "Generated dataset."
    },
    {
      "name": "ex",
      "label": "Exposure",
      "description": "A SDTM EX dataset from the CDISC pilot project",
      "source": "https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/ex.xpt?raw=true"
    },
    {
      "name": "ex_ophtha",
      "label": "Exposure for Ophthalmology",
      "description": "An example Exposure SDTM dataset with ophthalmology-specific variables such as `EXLOC` and `EXLAT`",
      "source": "Constructed using ex from the {pharmaversesdtm} package"
    },
    {
      "name": "lb",
      "label": "Laboratory Measurements",
      "description": "An updated SDTM LB dataset that uses data from the CDISC pilot project",
      "source": "https://github.com/pharmaverse/pharmaversesdtm/blob/main/data/lb.rda",
      "author": "Annie Yang"
    },
    {
      "name": "mh",
      "label": "Medical History",
      "description": "An updated SDTM MH dataset that uses data from the CDISC pilot project",
      "source": "https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/mh.xpt?raw=true",
      "author": "Annie Yang"
    },
    {
      "name": "oe_ophtha",
      "label": "Ophthalmic Examinations for Ophthalmology",
      "description": "A SDTM OE dataset simulated by Ophthalmology team",
      "source": "Generated dataset.",
      "author": "Gordon Miller"
    },
    {
      "name": "pc",
      "label": "Pharmacokinetic Concentrations",
      "description": "A SDTM PC dataset simulated by Antonio Rodriguez Contesti",
      "source": "https://github.com/pharmaverse/pharmaversesdtm/blob/main/data/pc.rda",
      "author": "Antonio Rodriguez Contesti"
    },
    {
      "name": "pp",
      "label": "Pharmacokinetic Parameters",
      "description": "A SDTM PP dataset simulated by Antonio Rodriguez Contesti",
      "source": "https://github.com/pharmaverse/pharmaversesdtm/blob/main/data/pp.rda",
      "author": "Antonio Rodriguez Contesti"
    },
    {
      "name": "qs_ophtha",
      "label": "Questionnaire for Ophthalmology",
      "description": "An example Questionnaires SDTM dataset with ophthalmology-specific questionnaire of NEI VFQ-25",
      "source": "Constructed using qs from the {pharmaversesdtm} package"
    },
    {
      "name": "sc_ophtha",
      "label": "Subject Characteristic for Ophthalmology",
      "description": "A SDTM SC dataset simulated by Ophthalmology team",
      "source": "Generated dataset.",
      "author": "Gordon Miller"
    },
    {
      "name": "tu_onco",
      "label": "Tumor Identification for Oncology",
      "description": "A SDTM TU dataset simulated by Gopi Vegesna",
      "source": "Generated dataset.",
      "author": "Gopi Vegesna"
    },
    {
      "name": "tr_onco",
      "label": "Tumor Results for Oncology",
      "description": "A SDTM TR dataset simulated by Gopi Vegesna",
      "source": "Generated dataset.",
      "author": "Gopi Vegesna"
    },
    {
      "name": "rs_onco",
      "label": "Disease Response for Oncology",
      "description": "A SDTM RS dataset simulated by Gopi Vegesna",
      "source": "https://github.com/pharmaverse/pharmaversesdtm/blob/main/data/tr_onco_recist.rda",
      "author": "Gopi Vegesna"
    },
    {
      "name": "tr_onco_recist",
      "label": "Tumor Results (RECIST 1.1) for Oncology",
      "description": "A SDTM TR dataset using RECIST 1.1 intended for examples of ADaM dataset creation",
      "source": "Generated dataset.",
      "author": "Stefan Bundfuss"
    },
    {
      "name": "tu_onco_recist",
      "label": "Tumor Identification (RECIST 1.1) for Oncology",
      "description": "A SDTM TU dataset using RECIST 1.1 intended for examples of ADaM dataset creation",
      "source": "Generated dataset.",
      "author": "Stefan Bundfuss"
    },
    {
      "name": "rs_onco_recist",
      "label": "Disease Response (RECIST 1.1) for Oncology",
      "description": "A SDTM RS dataset using RECIST 1.1 intended for examples of ADaM dataset creation",
      "source": "Generated dataset.",
      "author": "Stefan Bundfuss"
    },
    {
      "name": "rs_onco_irecist",
      "label": "Disease Response (iRECIST) for Oncology",
      "description": "A SDTM RS dataset using iRECIST intended for examples of ADaM dataset creation",
      "source": "Generated dataset.",
      "author": "Rohan Thampi"
    },
    {
      "name": "rs_onco_imwg",
      "label": "Disease Response (IMWG)",
      "description": "A SDTM RS dataset using IMWG criteria intended for examples of ADaM dataset creation",
      "source": "Derived from tr_onco_recist",
      "author": "Vinh Nguyen"
    },
    {
      "name": "supprs_onco_imwg",
      "label": "Supplemental Qualifiers for RS_ONCO_IMWG",
      "description": "A SDTM supplemental RS dataset using IMWG criteria intended to be used with `rs_onco_imwg`",
      "source": "https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/suppae.xpt?raw=true",
      "author": "Vinh Nguyen"
    },
    {
      "name": "rs_onco_ca125",
      "label": "Disease Response (GCIG)",
      "description": "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.",
      "source": "Generated dataset ([rs_supprs_onco_ca125.R](https://github.com/pharmaverse/pharmaversesdtm/blob/main/data-raw/rs_supprs_onco_ca125.R))",
      "author": "Vinh Nguyen"
    },
    {
      "name": "supprs_onco_ca125",
      "label": "Supplemental Qualifiers for RS_ONCO_CA125",
      "description": "A SDTM supplemental RS dataset using GCIG criteria. It is intended to be used together with `rs_onco_ca125`.",
      "source": "Generated dataset ([rs_supprs_onco_ca125.R](https://github.com/pharmaverse/pharmaversesdtm/blob/main/data-raw/rs_supprs_onco_ca125.R))",
      "author": "Vinh Nguyen"
    },
    {
      "name": "rs_onco_pcwg3",
      "label": "Disease Response (PCWG3) for Oncology",
      "description": "A SDTM RS dataset for oncology studies using PCWG3 criteria intended for examples of ADaM dataset creation",
      "source": "Generated dataset",
      "author": "Tomoyuki Namai"
    },
    {
      "name": "suppae",
      "label": "Supplemental Adverse Events",
      "description": "A SDTM SUPPAE dataset from the CDISC pilot project",
      "source": "https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/suppds.xpt?raw=true"
    },
    {
      "name": "suppds",
      "label": "Supplemental Disposition",
      "description": "A SDTM SUPPDS dataset from the CDISC pilot project",
      "source": "https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/suppdm.xpt?raw=true"
    },
    {
      "name": "suppdm",
      "label": "Supplemental Demography",
      "description": "A SDTM SUPPDM dataset from the CDISC pilot project",
      "source": "Generated dataset."
    },
    {
      "name": "supptr_onco",
      "label": "Supplemental Tumor Results for Oncology",
      "description": "A SDTM SUPPTR dataset simulated by Gopi Vegesna",
      "source": "https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/ts.xpt?raw=true",
      "author": "Gopi Vegesna"
    },
    {
      "name": "ts",
      "label": "Trial Design",
      "description": "A SDTM TS dataset from the CDISC pilot project",
      "source": "https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/vs.xpt?raw=true"
    },
    {
      "name": "vs",
      "label": "Vital Signs",
      "description": "A SDTM VS dataset from the CDISC pilot project",
      "source": "Generated dataset."
    },
    {
      "name": "smq_db",
      "label": "Standardized MedDRA Queries",
      "description": "An example SMQ dataset",
      "source": "Generated dataset."
    },
    {
      "name": "sdg_db",
      "label": "SDG",
      "description": "An example SDG dataset",
      "source": "https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/sv.xpt?raw=true"
    },
    {
      "name": "sv",
      "label": "Subject Visits",
      "description": "A SDTM SV dataset from the CDISC pilot project with corrected duplicate observation",
      "source": "Constructed by {admiralvaccine} developers"
    },
    {
      "name": "dm_vaccine",
      "label": "Demographics for Vaccine",
      "description": "An example SDTM DM dataset for vaccine studies",
      "source": "Constructed by {admiralvaccine} developers"
    },
    {
      "name": "vs_vaccine",
      "label": "Vital Signs for Vaccine",
      "description": "An example SDTM VS dataset for vaccine studies",
      "source": "Constructed by {admiralvaccine} developers"
    },
    {
      "name": "ce_vaccine",
      "label": "Clinical Events for Vaccine",
      "description": "An example SDTM CE dataset for vaccine studies",
      "source": "Constructed by {admiralvaccine} developers"
    },
    {
      "name": "ex_vaccine",
      "label": "Exposures for Vaccine",
      "description": "An example SDTM EX dataset for vaccine studies",
      "source": "Constructed by {admiralvaccine} developers"
    },
    {
      "name": "is_vaccine",
      "label": "Immunogenicity Specimen Assessments for Vaccine",
      "description": "An example SDTM IS for vaccine studies",
      "source": "Constructed by {admiralvaccine} developers"
    },
    {
      "name": "face_vaccine",
      "label": "Findings About Clinical Events for Vaccine",
      "description": "An example SDTM FACE for vaccine studies",
      "source": "Constructed by {admiralvaccine} developers"
    },
    {
      "name": "suppce_vaccine",
      "label": "Supplemental Qualifiers for Clinical Events for Vaccine",
      "description": "An example SDTM SUPPCE for vaccine studies",
      "source": "Constructed by {admiralvaccine} developers"
    },
    {
      "name": "suppdm_vaccine",
      "label": "Supplemental Qualifiers for Demographics for Vaccine",
      "description": "An example SDTM SUPPDM dataset for vaccine studies",
      "source": "Constructed by {admiralvaccine} developers"
    },
    {
      "name": "suppex_vaccine",
      "label": "Supplemental Qualifiers for Exposures for Vaccine",
      "description": "An example SDTM SUPPEX dataset for vaccine studies",
      "source": "Constructed by {admiralvaccine} developers"
    },
    {
      "name": "suppface_vaccine",
      "label": "Supplemental Qualifiers for Findings About for Clinical Events for Vaccine",
      "description": "An example SDTM SUPPFACE dataset for vaccine studies",
      "source": "Constructed by {admiralvaccine} developers"
    },
    {
      "name": "suppis_vaccine",
      "label": "Supplemental Qualifiers for Immunogenicity Specimen Assessments for Vaccine",
      "description": "An example SDTM SUPPIS dataset for vaccine studies",
      "source": "Constructed by {admiralpeds} developers"
    },
    {
      "name": "dm_peds",
      "label": "Demographic Dataset-pediatrics",
      "description": "An updated SDTM DM dataset with pediatric patients",
      "source": "Constructed by {admiralpeds} developers"
    },
    {
      "name": "vs_peds",
      "label": "Vital signs Dataset-pediatrics",
      "description": "An updated SDTM VS dataset with anthropometric measurements for pediatric patients",
      "source": "Constructed by {admiralpeds} developers"
    },
    {
      "name": "dm_metabolic",
      "label": "Demographic Dataset-metabolic",
      "description": "A SDTM DM dataset for metabolic studies",
      "source": "Constructed by {admiralmetabolic} developers"
    },
    {
      "name": "vs_metabolic",
      "label": "Vital signs Dataset-metabolic",
      "description": "A SDTM VS dataset for metabolic studies",
      "source": "Constructed by {admiralmetabolic} developers"
    },
    {
      "name": "qs_metabolic",
      "label": "Questionnaire Dataset-metabolic",
      "description": "A SDTM QS dataset containing COEQ data (Control of Eating Questionnaire) for metabolic studies. Note that University of Leeds are the copyright holders of the Control of Eating Questionnaire (CoEQ) and the test data included within pharmaversesdtm as well as the ADCOEQ code are for not-for-profit use only within admiralmetabolic and pharmaverse-related examples/documentation. Any persons or companies wanting to use the CoEQ should request a license to do so from the following [link](https://licensing.leeds.ac.uk/product/control-of-eating-questionnaire-coeq).",
      "source": "Constructed by {admiralmetabolic} developers"
    },
    {
     "name": "lb_metabolic",
     "label": "Laboratory Measurements Dataset-metabolic",
     "description": "A SDTM LB dataset containing relevant laboratory measurements for metabolic studies",
     "source": "Constructed by {admiralmetabolic} developers"
    }
  ]
}
