representation and use of clinical data in immport
DESCRIPTION
Representation and Use of Clinical Data in Immport. David Karp, M.D., Ph.D. Richard Scheuermann, Ph.D. General Thoughts Regarding Clinical Data. Please make sure any prospectively collected data used consent forms that take data sharing into account. Other researchers NIH De-identified - PowerPoint PPT PresentationTRANSCRIPT
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA region genomics consortium
Representation and Use of Clinical Data in Immport
David Karp, M.D., Ph.D.Richard Scheuermann, Ph.D.
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HLA Genetics Consortium Meeting, December 14-15, 2010
General Thoughts Regarding Clinical Data
Please make sure any prospectively collected data used consent forms that take data sharing into account. Other researchers NIH De-identified
No Protected Healthcare Information is displayed. E.g., dates are converted to study times
Genetic data such as SNP haplotypes or frequencies are not part of the Semi-Public Workspace.
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HLA Genetics Consortium Meeting, December 14-15, 2010
Levels of Clinical Data
Simple – Subject demographics and phenotype Can use built-in data submission templates (Excel)
Complex – Clinical measurements, time course Vital signs CBC Chemistry Serologies Response to vaccination Pulmonary function tests BASDI, BASFI, Rodnan Skin Score, etc.
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HLA Genetics Consortium Meeting, December 14-15, 2010
Submitting Clinical Data
Investigator controls data during loading Give BISC team (Meagan Kong, Ph.D.) a data dictionary,
protocol, and database schema We create map from your data to our data model You generate the load file More time-consuming on your part
Investigator gives data to BISC for loading BISC team creates data maps and load files Investigator can then validate the data integrity
Neither method is easy to do incrementally – best to have all data loaded at once
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HLA Genetics Consortium Meeting, December 14-15, 2010
Standard Subject Templates
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HLA Genetics Consortium Meeting, December 14-15, 2010
ImmPort Data Templates
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HLA Genetics Consortium Meeting, December 14-15, 2010
Content of Study Design Workbook
StudyInterventional ParametersObservational ParametersInclusion Exclusion
Arm or CohortPeriodEvent PlanVisit PlanVisit to ArmEvent PanelEvent Panel components
SiteStudy Personnel
Subject Measure DefinitionsOutcome Measure Definitions
Glossary
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HLA Genetics Consortium Meeting, December 14-15, 2010
Cartoon Representation of ImmPort Study Schema
StudyTitleObjectivesDescription…
ARM_or_COHORTArm_NameNameDescription…
PLANNED_VISITVisit_Order_NumberVisit_Name…
PLANNED_EVENTEvent_Name_Reported…
PERIODTitleOrder_number…
VISIT_2_ARM
PLANNED_EVENT_2_EVENT_PANEL
EVENT_PANELUser_Def_Event_Panel_IDEvent_Panel_Desc…
EVENT_PANEL_COMPONENTSComponent_Order_NumComponent_Desc…
INTERVENTIONAL_PARAMETERSPrimary_PurposeStudy_Phase…
OUTCOME_MEASURE_DEFINTIONAnalysisPopDescOutcomeType…
OBSERVATIONAL_PARAMETERSObservation_ModelTime_perspective…
SUBJECT_MEASURE_DEFINTIONOutcomeTypeMeasureType…
POPULATION_SELECTION_RULEPopulation_NameDesc…
SITESite_Name…
STUDY_PERSONNELLast_NameFirst_Name…
STUDY_PERSONNEL_2_SITE
GLOSSARYTermDefinition…
INclUSION_EXCLUSIONCriterion_NameCriterion_Category…
Nov 2009
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HLA Genetics Consortium Meeting, December 14-15, 2010
Study Design Workbook
Study
Arm or Cohort
Period
Event Plan
Visit Plan
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HLA Genetics Consortium Meeting, December 14-15, 2010
Study Design Workbook
Observational parameters
Interventional Parameters
Subject Measure Definitions
Dropdown Menus
Comments
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HLA Genetics Consortium Meeting, December 14-15, 2010
Case Report Form Data Templates Content
Biosampling (e.g., Blood draw)Substance Merge (e.g., Medication)Assessment (e.g., Medical History)Lab test Reference RangeAdverse EventEarly TerminationProtocol DeviationActual Visit
Subject Measure ResultsLab Test (panel ) Derived Results
Arm or Cohort to SubjectBiosampling to Biological SamplesStudy to Protocol
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HLA Genetics Consortium Meeting, December 14-15, 2010
Case Report Form Data Templates
Assessment (e.g., Medical History, Family History, Vital Signs)
Biosampling
Lab Test
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HLA Genetics Consortium Meeting, December 14-15, 2010
Case Report Form Data Submission
Mapping File Generation
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HLA Genetics Consortium Meeting, December 14-15, 2010
Experiment (Mechanistic Assay)
SUBJECTNameDescription…
BIOLOGICAL SAMPLENameDescription…
EXPERIMENT_SAMPLENameDescription…
EXPERIMENTNameDescription…
PROTOCOLNameDescription…
Assay ResultsNameDescription…
REAGENTNameDescription…
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
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HLA Genetics Consortium Meeting, December 14-15, 2010
Tube 33 Population 2
Lymphocyte Region
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HLA Genetics Consortium Meeting, December 14-15, 2010
ImmPort Clinical Data
ImmPort currently has a wealth of experimental data in the personal workspaces of investigators
Use of data in the Semi-Public Workspaces offers an exciting ability to collaborate, generate hypotheses, and share data
Structured data models are necessary to use complex clinical research data
Mapping data to make it useful for translational and clinical studies is time-consuming – work with us early!