Representation and Use of Clinical Data in Immport

HLA Genetics Consortium Meeting, December 14-15, 2010

HLA region genomics consortium

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

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.


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.


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


Standard Subject Templates


ImmPort Data Templates


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


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


Study Design Workbook

Study

Arm or Cohort

Period

Event Plan

Visit Plan


Study Design Workbook

Observational parameters

Interventional Parameters

Subject Measure Definitions

Dropdown Menus

Comments


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


Case Report Form Data Templates

Assessment (e.g., Medical History, Family History, Vital Signs)

Biosampling

Lab Test


Case Report Form Data Submission

Mapping File Generation


Experiment (Mechanistic Assay)

SUBJECTNameDescription…

BIOLOGICAL SAMPLENameDescription…

EXPERIMENT_SAMPLENameDescription…

EXPERIMENTNameDescription…

PROTOCOLNameDescription…

Assay ResultsNameDescription…

REAGENTNameDescription…

























Tube 33 Population 2

Lymphocyte Region


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!

Documents

Representation and Use of Clinical Data in Immport