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Study Start-Up
The Start-up module is available to users who have the Study Start-up action selected in the user profile, who are members of the data room’s Study Start-up Team group, and who are Start-up Specialists in the data room.

Study Start-Up

The Start-up module is available to users who have the Study Start-up action selected in the user profile, who are members of the data room’s Study Start-up Team group, and who are Start-up Specialists in the data room.

Study Start-Up has the following changes seen in TI v10.5. The changes are explained in brief here and feature-wise in detail in the coming pages.

New UX Design – The SSU design aligns with the TI v10 interface.

Contracts and Budgets – SSU introduces contracts and budgets to upload/track in SSU.

Activate Countries/IRBs – This allows the SSU specialist to meet all country/IRB requirements before activating any site.

Improved Agency Submissions – It can arrange the order of documents and rename them required for agency submissions.

Improved Amendments – SSU now has an easy way to create, complete, and track amendments for all categories.

Improved IRB Profile - allows users to associate multiple IRBs to a site with an addition to assign a central or local IRB.

New Dashlet for tracking Cycle Time – SSU has a new dashlet to track cycle time for different stages of site activation.