CRC Support
CRC Support
The Clinical Research Center (CRC) offers specialized support for researchers conducting studies involving human subjects. With a safe and controlled environment, expert staff, and comprehensive resources, the CRC is designed to facilitate high-quality inpatient and outpatient research. By providing infrastructure and services such as nursing, nutrition, and laboratory support, the CRC helps streamline study execution and ensures compliance with research protocols. Researchers seeking reliable and efficient support for their studies can benefit from the CRC’s expertise and commitment to advancing medical research.
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Features
Key features include access to expert nursing care, DXA scanning, nutrition research services, and blood draw and processing capabilities. The CRC also offers a controlled environment for vital sign monitoring and other study procedures, ensuring safety and precision. Additionally, the center provides cost estimates, protocol feasibility reviews, and guidance throughout the application and approval process, helping researchers efficiently plan and execute their studies.
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Protocol Approval Process
The CRC must approve a protocol prior to conducting research procedures on study subjects on the CRC or using CRC resources.
Please note the following information about the CRC protocol submission/review process:
- IRB (RSRB, single IRB, or central IRB) approval is required prior to CRC review.
- The CRC review consists of a feasibility review for the requested use of CRC services or resources. The CRC is committed to a prompt review of the protocol for feasibility.
- The review process starts upon receipt of the CRC application, IRB approval, and all required study documents. All protocol materials need to be submitted at the same time.
- If there are no questions or issues needing clarification during the review process, the protocol can be approved, and a CRC protocol number can be provided by the fifth business day after CRC receipt of the protocol.
- If the PI responds promptly to any questions or items of clarification arising from the review, it is estimated that the turnaround time for the feasibility review would be a total of two weeks from CRC receipt of the complete protocol submission package.
- The CRC strongly encourages study teams to work with the CRC staff prior to protocol submission to work out potential issues and reduce the time to approval.
Submitting Protocols Involving CRC Resources
New Protocol Submissions
A. Protocols Reviewed by the RSRB (University of Rochester IRB):
- When completing the protocol application in the Click IRB system, indicate that the study will utilize the CRC's resources.
- After receiving RSRB approval, complete the online application for review by the CRC.
B. Protocols Reviewed by an External IRB:
- After receiving IRB approval (indicating that the University of Rochester is an approved research site), complete the online application for CRC review.
- Once all required documents are submitted, the CRC feasibility review will begin.
Adding CRC Resources or Services to an Approved Study
- Complete the online application to request the addition of CRC resources or services.
- If the study was reviewed by an external IRB, ensure the IRB approval document specifies that the University of Rochester is an approved research site.
Required Components for CRC Protocol Review
- The table below outlines the components required for CRC protocol review.
- The required components depend on the level of CRC involvement in the study.
- Note: Incomplete submissions may delay the review process.
CRC Involvement | Protocol | IRB-Approved Consent Form | IRB Documentation of Approval | Laboratory Manual, if Available |
|---|---|---|---|---|
Nursing | yes | yes | yes | yes |
Nutrition Services | yes | yes | yes | no |
Blood draw and processing (blood drawn on the CRC) | yes | yes | yes | no |
Blood processing (blood draws not conducted on the CRC) | yes | yes | yes | no |
Vital signs only | yes | yes | yes | no |
DXA | yes | yes | yes | no |
CRC Use (no services other than emergency nursing services or vital signs) | yes | yes | yes | no |
Protocol Amendments
When a protocol amendment impacts the CRC, a CRC Amendment Submission Form and supporting documentation need to be submitted to UR CTSI for CRC review. It is the responsibility of the study team to communicate protocol changes that impact the CRC.
Regardless of whether or not an amendment directly impacts the CRC, if the protocol or consent form is revised, a revised copy of the protocol or consent form needs to be forwarded to UR CTSI.
Cost
| Service | Non-Industry Rate | Industry Rate |
|---|---|---|
| CRC Industry Submission Fee | 1,356.88 | |
| CRC Visit Charges [1] [5] | ||
| Low Complexity Visit Hourly Rate (Level 1) [3] | 55.00 | 56.00 |
| Medium Complexity Visit Hourly Rate (Level 2) [4] | 103.44 | 105.32 |
| High Complexity Visit Hourly Rate (Level 3) | 180.99 | 184.28 |
| CRC Inpatient Rate (per Night) [2] | 2,845.92 | 2,897.66 |
| Bionutrition Services (Hourly) [1] | 62.49 | 62.49 |
| Study Coordinator Services [1] | ||
| Coordinator Services (Hourly) | 44.80 | 44.80 |
| Coordinator Trainee Services (Hourly) | 38.16 | 38.16 |
| Blood Draw Only (per Draw) | 27.50 | 27.50 |
| DXA Scan (per Session) | 593.38 | 604.17 |
| Recruitment Services | ||
| Recruitment Set-up Package (per Service) | 500.00 | 1000.00 |
| HighEnroll App (per Service) | 1,304.28 | 1,434.94 |
| Participant Recruitment Marketing (per Service) | 454.90 | 521.26 |
| ResearchMatch.org Registry (per Service) | 53.00 | 58.73 |
[1] All visits are charged a minimum of one hour.
[2] Inpatient visits are charged at a flat rate and include the services of one RN.
[3]A visit at this level would include emergency nursing services, vital signs, use of CRC-owned equipment, and provision of standard supplies.
[4]A visit at this level would include the services/resources in Level 1, as well as blood draws and processing.
[5]The level of service chosen will be determined by the type of services requested and the complexity of the protocol.
Cost Estimates
It is highly recommended that investigators obtain a CRC cost estimate as budgets are developed for grants and industry-funded protocols. The cost estimate request form must be submitted to CTSI@urmc.rochester.edu. Please note that when studies using the CRC are submitted through IORA, a budget review is conducted to ensure that CRC costs are appropriately included. If a cost estimate has not been obtained before submission in IORA, there could be a delay in approving the study while a cost estimate is developed, and the updated budget is reviewed.
To request a cost estimate, please submit a CRC Cost Estimate Request Form to UR CTSI, along with the protocol or portion of the grant detailing the research study.
Contact
Questions about the application process or use of CRC services should be addressed to the following CRC personnel:
- Application Process: Karen Grabowski
- Nursing and DXA: Ann Miller at (585) 275-2907
- Nutrition Research: Nellie Wixom at (585) 275-4761
- Coordinator Services: JoAnne VanBuskirk at (585) 275-4729
Resources
- CRC Amendment Submission Form
- Preparing-for-a-CRC-In-service-Form
- CRC-Subject-Visit-Checklist-for-Coordinators
- Patient Care Orders templates:
- Once completed and signed appropriately, these templates can be used for Patient Care Orders. Any questions regarding this form should be directed to CRC Nurse Manager, Ann Miller at (585) 275-2907.
- Patient Care Orders - 1 open text section
- Patient Care Orders - 2 open text sections
- Patient Care Orders - 3 open text sections
- Patient Care Orders - 4 open text sections
- Study Visit Orders - This document should be used for studies that are minimal risk and have no medications ordered.
- Suggested Wording for CRC Procedures for Protocols/Consents - This document details research procedures commonly used on the CRC and specific descriptive wording, which can be used in the protocol and informed consent.