1. Study Design, Study Participation Retrieve Protocol for Executation
Jason Rock CTO, GlobalSubmit

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. Ia Ib S F Ib Ia Ia Ib S F Ib Ia Time Point Event Epoch Epoch Screen
Epoch Intervention
Epoch Intervention
Epoch Follow-Up
Epoch Ia Ib S F Ib Ia
Epoch Screen
Epoch Intervention
Epoch Follow-Up Ia Ib S F Ib Ia

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

13. Ia 25 Ia 50 Ib 25 S 100 F 100 Ia 25 Ib 50 Ib 25 Time Point Event Epoch
Subject Assignment
And
Defines Arm
Subject Assignment
Time Point Event
Epoch Screen
Epoch Intervention
Epoch Intervention
Epoch Follow-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

16. Units Assignment
Could be site dependent

17. Study Participation
A study is performed at sites

18. Research Subjects
Subject are enrolled to sites

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