Application and Review Process

Applications to use CCaTS facilities undergo two types of review.

• Operational review. The operational review committee consists of a nurse manager, core lab managers, dietitian, and pharmacy and processing lab supervisor and coordinators. The purpose of the operational review is to determine if CCaTS has the resources needed to support a given protocol.
• Human subject protection review. The Mayo Clinic Institutional Review Board (IRB) reviews all human subject research conducted at Mayo Clinic (Arizona, Florida and Rochester campuses) 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) through the Federalwide Assurance (FWA) for the Protection of Human Subjects (FWA00005001).

Application Review Process (PDF)

Frequently asked questions

Before applying

Where can I find a full list of CCaTS facilities?

Visit the main pages for the Clinical Research and Trials Unit (CRTU) and laboratories.

Who is eligible to use CCaTS facilities?

The staff, facilities (CRTU, Laboratories) and resources of CCaTS are available to everyone involved in research at Mayo Clinic.

How do I apply to use CCaTS facilities?

The process for applying starts in the Protocol Lifecycle Management (PLM) system. For the question: "Will the Rochester Clinical Research and Trials Unit (CRTU) and Translational Technology Cores (TTC) resources be utilized?" Answer "yes" and this will initiate additional information in the IRBe application.

What is the application process for using CCaTS facilities?

Use the IRB's electronic application system, IRBe. Complete the application sections specific to CRTU/TTC: Administration and Census, Resource Summary, and Minority Inclusion Information. Submit the application for CRTU/TTC Operational Review Committee. The Committee will review to determine if resources are available to support the protocol.

How much does it cost to use CCaTS facilities?

For budget information please see our website (must be logged in to the Mayo network): Clinical Research and Trials Unit (CRTU) – RST.

Resources include:

• CRTU Budget Estimator
• CRTU Budget Requests for Industry Funded Studies

Where can I find funding opportunities to support my study?

There are multiple intramural funding opportunities available from CCaTS. More opportunities can be found on the Mayo Clinic Office of Sponsored Projects Administration (OSPA) intranet site (must be logged in to the Mayo network).

How do I obtain statistical support if my department does not have a Ph.D.-level statistician?

Contact the CCaTS Service Center at 507-255-7101 to make an appointment with a consultant in the CCaTS biostatistics, epidemiology and research design (BERD) resource.

After applying

What is a flowsheet meeting? How do I schedule one?

Flowsheet meetings are held prior to protocol implementation in the CRTU and include the CRTU R.N. coordinator, principal investigator 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 CRTU. A flowsheet meeting may be requested after the operational review by completing and submitting this online form or after IRB approval (must be logged in to the Mayo network).

What is a special studies meeting? How do I schedule one?

Special studies meetings are required to arrange services provided for research by the Department of Laboratory Medicine and Pathology (DLMP) (must be logged in to the Mayo network) and/or the Immunochemical Core. A meeting can be requested by visiting the DLMP Special Studies Lab Services intranet site (must be logged in to the Mayo network).

After CCaTS and IRB approval

How do I activate my study?

The principal investigator 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 CRTU has completed preparatory work on the protocol and needs final approval before participants may be scheduled. The principal investigator or a key research team member may review the documents for completeness and accuracy and give approval. To give final approval, follow the link provided in the email.

How do I schedule participants for my study?

Information on the scheduling process and training can be found on our website (must be logged in to the Mayo network): Clinical Research and Trials Unit (CRTU) – RST.

How do I cite CCaTS in my publications?

Visit Citing CCaTS in Publications.