Once a study has Feasibility Approval, the Clinical Trials Support Unit will reach out to study teams to schedule a study planning meeting to begin the Pre-Award process.
The CTSU portfolio manager assists study teams with any pre-award activity challenges on the path to facilitate timely study activation. The portfolio manager tracks the project in its lifecycle, offers a line of communication between the CTSU and study teams, and keeps studies on track. Study teams are also able to track their trial’s status in OnCore. Learn more about OnCore.
Pre-/Post- Award services include, but are not limited to:
- Feasibility review (pre-award)
- Billing calendar creation (pre-award)
- Budget preparation and negotiation (pre-award)
- Contracting support (pre-award)
- Site initiation support (pre-award)
- Account reconciliation (post-award)
- Milestone tracking (post-award)
- Invoicing (post-award)
- Reporting (post-award)
The CTSUs offer regulatory support in preparation of the IRB application, amendments, and consent forms. Assistance is also offered in working with strategic partners including Michigan Institute for Clinical & Health Research (MICHR), Office of Research and Sponsored Projects (ORSP), Institutional Review Boards (IRBMED), Michigan Clinical Research Unit (MCRU), Research Pharmacy, and more.
As a trial moves into Post-Award, investigators will be contacted by their CTSU Lead Administrator to schedule a meeting to discuss their post-award reports. These reports provide a comprehensive snapshot of financial activities that allow investigators to adjust and plan for the future of their study. After the initial meeting, the reports are sent monthly via email to investigators.
CTSUs use a standard operations manual to harmonize elements across the clinical trial enterprise while allowing for local flexibility to reflect the uniqueness of various types of trials.