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Representation and Use of Clinical Data in Immport

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

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Representation and Use of Clinical Data in Immport

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  1. Representation and Use of Clinical Data in Immport David Karp, M.D., Ph.D. Richard Scheuermann, Ph.D.

  2. 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.

  3. 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.

  4. 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

  5. Standard Subject Templates

  6. ImmPort Data Templates

  7. Content of Study Design Workbook Study Interventional Parameters Observational Parameters Inclusion Exclusion Arm or Cohort Period Event Plan Visit Plan Visit to Arm Event Panel Event Panel components Subject Measure Definitions Outcome Measure Definitions Site Study Personnel Glossary

  8. Cartoon Representation of ImmPort Study Schema POPULATION_ SELECTION_RULE Population_Name Desc … GLOSSARY Term Definition … SUBJECT_ MEASURE_DEFINTION OutcomeType MeasureType … OUTCOME_MEASURE_ DEFINTION AnalysisPopDesc OutcomeType … INTERVENTIONAL_ PARAMETERS Primary_Purpose Study_Phase … STUDY_ PERSONNEL_ 2_SITE STUDY_PERSONNEL Last_Name First_Name … SITE Site_Name … Study Title Objectives Description … OBSERVATIONAL_ PARAMETERS Observation_Model Time_perspective … PLANNED_VISIT Visit_Order_Number Visit_Name … INclUSION_ EXCLUSION Criterion_Name Criterion_Category … ARM_or_COHORT Arm_Name Name Description … VISIT_2_ARM EVENT_PANEL_ COMPONENTS Component_Order _Num Component_Desc … PERIOD Title Order_number … EVENT_PANEL User_Def_Event_Panel_ID Event_Panel_Desc … PLANNED_EVENT_ 2_EVENT_PANEL PLANNED_EVENT Event_Name_Reported … Nov 2009

  9. Study Design Workbook Study Arm or Cohort Period Event Plan Visit Plan

  10. Study Design Workbook Observational parameters Dropdown Menus Interventional Parameters Comments Subject Measure Definitions

  11. Case Report Form Data Templates Content Biosampling (e.g., Blood draw) Substance Merge (e.g., Medication) Assessment (e.g., Medical History) Lab test Reference Range Adverse Event Early Termination Protocol Deviation Actual Visit Arm or Cohort toSubject Biosampling to Biological Samples Study to Protocol Subject Measure Results Lab Test (panel ) Derived Results

  12. Case Report Form Data Templates Assessment (e.g., Medical History, Family History, Vital Signs) Biosampling Lab Test

  13. Case Report Form Data Submission Mapping File Generation

  14. Experiment (Mechanistic Assay) EXPERIMENT Name Description … SUBJECT Name Description … EXPERIMENT_SAMPLE Name Description … Assay Results Name Description … BIOLOGICAL SAMPLE Name Description … REAGENT Name Description … PROTOCOL Name Description …

  15. Tube 33 Population 2 Lymphocyte Region

  16. 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!

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