After investigators have filled out an intake form, the next step for a potential new clinical research study within the CTSU is a Feasibility Review. This is conducted by the CTSU in partnership with the study team to determine the logistical and financial feasibility in an effort to ensure the highest likelihood of a successful performance. The Feasibility Review looks at the whole picture to prevent any unexpected challenges in research execution and to open to accrual in a timely manner.
A Feasibility Review…
- Defines priorities for the use of CTSU and institutional resources
- Ensures scientific review and recognized peer review
- Improves the overall quality of clinical trials/research
- Promotes a high success rate of trial performance, including enrollment
- Helps ensure high-quality institutional support for all faculty and their teams, from early-career investigators to experienced researchers
Feasibility approval is required before submitting an IRB application, negotiating a budget, and full negotiation of the contract. Upon approval, all three of these activities will occur in parallel and will be managed by the CTSU, who will shepherd the project through the pre-award process. Investigators are able to track the feasibility process in OnCore, Michigan Medicine’s Clinical Trials Management System. Learn more about OnCore here.
It’s never too early to fill out a CTSU Intake Form!
Submitting an intake form allows the appropriate CTSU to determine what services a study team may need, and initiate pre-award support. Study Teams should fill out an Intake Form early in the process especially when they:
- Have received a confidentiality agreement from a sponsor — if available, attach an editable confidentiality agreement for the creation of an Unfunded Agreement (UFA) and Proposal Agreement Form (PAF)
- Are considering submitting a proposal that includes a clinical trial or clinical research with billable patient care items to an external sponsor
- Are preparing a proposal that includes a clinical trial for an internal funding source, including the use of pilot, discretionary, departmental, and/or gift funds
- Are seeking consultation, guidance, and/or mentorship on conducting a clinical trial at Michigan Medicine
When filling out the Intake Form, you will need to know principal investigator information, study team contact information, department pre-award research administrator information, and study information, including title, possible funding source, type of trial/research, and phase.
Need assistance with writing a protocol? Use one of our protocol templates.
If you would like further assistance, access the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) Checklist. As published in BMJ, the SPIRIT guidance provide full rationale and description, examples from actual protocols, and relevant references. Researchers are strongly encouraged to use the guidelines in conjunction with the SPIRIT Checklist.