To start with, watch this video that provides an overview of the Study Setup process. Then scroll down for more details.
https://vimeo.com/415583213/361cb73f53
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 |
|---|---|---|---|---|