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Study Design, Study Participation Retrieve Protocol for Executation

Study Design, Study Participation Retrieve Protocol for Executation. Jason Rock CTO, GlobalSubmit Jason.Rock@GlobalSubmit.Com 215-253-7474. Contents. Study Design Overview Study Activities Experimental Design Subject Assignment. Planned Study. RPE: Retrieve Protocol Def

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Study Design, Study Participation Retrieve Protocol for Executation

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  1. Study Design, Study ParticipationRetrieve Protocol for Executation Jason RockCTO, GlobalSubmitJason.Rock@GlobalSubmit.Com215-253-7474

  2. Contents • Study Design Overview • Study Activities • Experimental Design • Subject Assignment

  3. Planned Study • RPE: Retrieve Protocol Def • Study characteristics (e.g. objectives, phase) • Eligibility Criteria • Organize activities • Comparison purposes (Epochs) • Unique path of activities • Workflow • Including assigned subjects to treatments

  4. Protocol Amendments • RPE: Amend Protocol Def • Study plans can be updated

  5. Study Characteristics

  6. Eligibility Criteria • RPE: Enter Patient Request • Only eligibility criteria

  7. Workflow • RPE: Patient Screening Visit Scheduled • Protocol is a workflow • Time points are parts of flow • Each time points has parts • Based on structured programming • Sequence (order) • Selection (if) • Repeat (while)

  8. Activities • RPE: Patient Screening Visit Scheduled • Workflow parts have many activities • Encounters (visits) • Observations (lab tests) • Procedures • Supply • Etc

  9. Selection • Order of “if” statements • Complex condition rules • Execute synchronous or a synchronous

  10. Experimental Design • Arm and Epoch • Add as decoration

  11. Time Point Event EpochScreen EpochIntervention EpochIntervention EpochFollow-Up Epoch Ia Ib S F Ib Ia EpochScreen EpochIntervention EpochFollow-Up Ia Ib S F Ib Ia

  12. Subject Assignment • Parts of the workflow assign subjects • Assignment through • randomization or observation

  13. Subject Assignment And Defines Arm Subject Assignment Time Point Event EpochScreen EpochIntervention EpochIntervention EpochFollow-Up Epoch Ia 25 Arm: S-A-A-F Ia 50 Ib 25 Arm: S-A-B-F S 100 F 100 Ia 25 Arm: S-B-A-F Ib 50 Subjects Ib 25 Arm: S-B-B-F

  14. Experimental Units • People • Animals, virus, etc • Products • Parts, specimens • Groups

  15. Units Assignment • Could be site dependent

  16. Study Participation • A study is performed at sites

  17. Research Subjects • Subject are enrolled to sites

  18. Study States • Patient accruing status (registration event) • Data collection status

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