Application and Review Process
Applications to use CTSA facilities undergo two types of review.
- Operational review — The operational review committee consists of nurse managers, core lab managers, dieticians, Office for Diversity in Clinical Research staff, and pharmacy and processing lab coordinators. The purpose of the operational review is to determine if CTSA has the resources needed to support a given protocol. Review by an IRB specialist happens concurrently.
- Human subject protection review — The Mayo Clinic Institutional Review Board (IRB) reviews all human subject research conducted at all Mayo Clinic campuses (Arizona, Florida, Rochester) and research conducted at other facilities under the direction of Mayo staff. A guarantee that all human subject research at Mayo will be reviewed by the IRB has been given to the U.S. Department of Health and Human Services (HHS) in a Federalwide Assurance (FWA00005001).
View the process flow for application review (PDF)
Frequently asked questions
- Where can I find a full list of CTSA facilities?
- Who is eligible to use CTSA facilities?
- The staff, facilities (CRU, shared/core labs) and resources of the CTSA are available to everyone involved in research at Mayo Clinic.
- What is the application process for using CTSA facilities?
- Use the Institutional Review Board (IRB)'s electronic application system — IRBe — to submit your protocol. Complete the IRBe application forms and submit to the Clinical Research Unit/Translational Technology Cores (CRU/TTC), which is listed in the ancillary committee list. These forms include a place to attach items including the protocol abstract, budget, women and minority inclusion statements, consent forms and statistical approval documentation.
- In the IRBe application, how do I apply to use CTSA facilities?
- In the IRBe application, answer "yes" to the question, "Will the CRU and/or TTC be utilized?" (This is question two in section three). After answering "yes," you will be prompted to complete sections 51-54 of the IRBe application.
- How much does it cost to use CTSA facilities?
- Studies that are NIH-, Mayo- or foundation-funded are not charged for the use of the CRU or most shared/core laboratories. Industry-funded studies are charged for facility use. Contact the CRU business manager at 507-266-0462 for assistance developing a CRU budget.
- Where can I find funding opportunities to support my study?
- How do I obtain statistical support if my department does not have a Ph.D.-level statistician?
- What is the review process?
- What is a flowsheet meeting? How do I schedule one?
- Flowsheet meetings are held prior to protocol implementation in the CRU and include the CRU RN coordinator, PI or co-investigators, study coordinator, and other pertinent personnel to discuss the specific needs for implementing the study. They are required for all studies that utilize the CRU. A flowsheet meeting can be requested after the operational review by completing and submitting this online form (requires that you be logged in to the Mayo network).
- What is a special studies meeting? How do I schedule one?
After CTSA and IRB approval
- How do I activate my study?
- The principal investigator (PI) will receive an email with the subject line, "Your approval is needed for activation of IRB xx-xxxxxx." The email is generated after all sections on the protocol activation status report have been checked, and will state that the CRU has completed preparatory work on the protocol and needs final approval before participants may be scheduled. The PI or a key research team member may review the documents for completeness/accuracy and give approval.
- To give final approval, follow the link provided in the email.
- How do I schedule participants for my study?
- To schedule participants, you will need access to the CTSA scheduling system. Begin by completing the "request access" form (requires that you be logged in to the Mayo network).
- How do I cite the CTSA in my publications?