To start with, watch this video that provides an overview of the Study Setup process. Then scroll down for more details.
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And now let us explore each Study Setup Activity in more detail. Click on the first Study Setup Activity to go through the entire workflow.
You can also click on a particular step that interests you or sort the items by Study Setup Activity Group to learn more about a particular part of Study Setup.
# | Study Setup Activity Group | Study Setup Activity |
|---|---|---|
Study Configuration → | ||
2. | Study Configuration → | |
3. | Study Configuration → | Add Recruitment Questionnaire |
4. | Study Configuration → | Create Cohorts |
5. | Trial Design → | Create Safety Lab Panels |
6. | Trial Design → | Create Sample Processing Paths |
7. | Trial Design → | Create Study Events |
8. | Trial Design → | Create and Lock Unique Forms |
9. | Trial Design → | Create Code Lists |
10. | Trial Design → | Create Measurement Units |
11. | Trial Design → | Create Methods and Edit Checks |
12. | Trial Design → | Add Metadata Base Forms |
13. | Trial Design Review → | Unique Form Review |
14. | Approvals → | Safety Lab Panel Approval |
15. | Approvals → | Sample Processing Paths Approval |
16. | Trial Design → | Assemble Activity Plans |
17. | Trial Design Review → | Activity Plan Review |
18. | Approvals → | Activity Plans Approval |
19. | Trial Design → | Map Eligibility Criteria |
20. | Trial Design Review → | Eligibility Mapping Review |
21. | Approvals → | Eligibility Mapping Approval |
22. | Study Configuration → | Upload ICF Template |
23. | Approvals → | ICF Approval |
24. | Trial Design → | Configure Medical Coding |
25. | Study Configuration → | Establish Data Reviewers |
26. | Study Configuration → | Make Study Active |
Deep Dive
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Form Design | Base Forms | Cohort Settings | Study Build Review | Methods and Edit Checks |
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