Step 1: Confirm Site Participation

Interest Survey: Sites interested in participating in KESETT should complete the survey found on the Interested in Joining KESETT page.

Confirmation: Upon review, KESETT Leadership will confirm your site’s participation status. Please do not move on to the following steps until your site has been confirmed.

Step 2: Create UM Friend Account

New study team members require a University of Michigan Friend Account to access the KESETT Education and Training page and the Workbench. Please follow the instructions to create an account. More information for staff new to SIREN can be found on the SIREN Getting Started page.

Step 3: Initiate Start-Up Activities

Site Milestone Document: Begin tasks outlined in the KESETT Payment Milestone Document.​

Regulatory Guide Review: Familiarize yourself with the KESETT WebDCU User Account & Regulatory/Essential Document Process Guide (coming soon).

Step 4: WebDCU Setup

Team Member Accounts: Add all study team members to the KESETT WebDCU database.​

• Note: Each member must be added before trial commencement.​

Electronic Delegation of Authority (eDOA) Log: Create and submit the eDOA log, assigning roles and responsibilities.​

• Guidelines: Refer to the KESETT WebDCU User Account & Regulatory/Essential Document Process Guide (coming soon).

Step 5: Complete Training

Complete the mandatory trainings as outlined on the KESETT Education and Training page.

Step 6: Finalize Regulatory Documents

Document Completion: Ensure all regulatory documents are accurately completed and uploaded to WebDCU.​

• Prerequisites: All team members must be added to WebDCU and the eDOA log prior to this step.

Step 7: Assess Site Readiness

Status Navigation: Review Site Readiness Status Navigation slides (coming soon)

Readiness Call: Schedule a readiness call using the Readiness Call Checklist (coming soon)