I. Applying to CRC
- How do I apply to use CRC resources?
See How to Apply for a list of required documents and instructions on how to apply.
- I have a question, who should I contact?
If your study is complex in nature or you have any questions about the application process, please contact the CRC personnel listed on Appendix A prior to submission. If you need to speak to more than one person in the CRC regarding your study needs, it may be helpful to schedule a meeting; you may contact Ms. Lisa Godin at 860.679.4145 to arrange the meeting, or contact Ms. Pamela Fall at 860.679.3681 if you have any questions.
- What if I have a budget deficit?
If the Office of Clinical and Translational (OCTR) budget for your study has a deficit and you are applying to the CRC to cover that deficit, then we advise you apply to CRC before applying to the IRB.
- When will my CRC application be reviewed?
See Dates for application deadlines and committee meeting dates.
- My project does not yet have final IRB approval. May I still apply to CRC?
Yes. Provide to CRC the draft/unapproved versions of applicable documents. For example, if the IRB-approved ICF and HIPAA documents are not available at the time of CRC application, provide the draft/unapproved versions as submitted (or to-be-submitted) to IRB. Please also download and provide to CRC a copy of the completed IRB application form from the electronic IRB submission system. All studies must be reviewed and approved by the IRB prior to accessing CRC resources.
- What do I do if I’m applying to IRB concurrently?
CRC encourages investigators who are applying for CRC resources to consult with a CRC core leader (see Appendix A for core leaders) prior to IRB submission, if possible. This will help ensure the information on Appendix A is accurate. If you are applying to IRB concurrent with your CRC submission, please inform Ms. Godin when submitting your CRC application materials to her. Please contact the CRC Research Subject Advocate, Ms. Kristen Tremblay, if you have any questions about CRC requirements related to the IRB application form.
- How does CRC review projects that are partially funded vs. fully funded?
All projects requesting CRC resources will be reviewed by one of two committees, either the Scientific Advisory Committee (SAC) or the Clinical Research Service Center (CRSC) Committee. When you complete the CRC resource request form (i.e., Appendix A), you select one method to apply under based on your project’s funding status. This determines which committee reviews your resource request (see also Appendix A):
- Scientific Advisory Committee (SAC): Partially funded projects are reviewed by the SAC, either through the full-board SAC scientific review process (i.e., assignment of peer reviewers, then review/discussion by the committee) or, if applicable for expedited review, by the SAC chair or vice-chair.
- Clinical Research Service Center (CRSC) Committee: Fully funded projects (i.e., fee-for-service resource requests) are reviewed by the CRSC committee. Some fee-for-service requests for CRC resources may be handled on a case-by-case basis by the applicable core director (e.g., fee-for-service use of Core Lab services).
All projects utilizing CRC resources must have undergone a scientific review by some entity (e.g., NIH, FDA, etc).
- What resources does CRC offer to help me conduct my project?
Please review the Services webpage for a detailed explanation of the resources available to investigators. See also Appendix A.
- Who can apply to use CRC resources?
CRC resources are available to UConn Health or UConn Storrs faculty members, who will be charged the UConn Health internal rate when paying for resources with internal funds. CRC resources may be accessed by researchers at other area hospitals for external rates, unless other arrangements are approved by the CRC Scientific Advisory Committee (SAC).
- What should I include in my research protocol?
A research protocol serves as a guide for the study team. Protocols submitted to CRC for review should include, at minimum: background, rationale, objectives, design/methodology, statistical evaluation of the data, and organization of the project. The research protocol is an important document to facilitate accurate study implementation.
II. Existing Approved and Ongoing Projects
- Once approved by CRC, when can I start my project?
Investigators must provide CRC with documentation of IRB-approval (and any other applicable approvals) prior to accessing CRC resources. The CRC also generally requires a project initiation meeting to be scheduled with the PI, his/her applicable staff, and applicable CRC personnel. This meeting serves to orient all individuals to the study conduct and CRC responsibilities.
- What if my resource needs change?
If your projected resources do not coincide with your SAC or CRSC approval letter(s), then you will need to submit a Change to Protocol form for consideration to be given by the SAC or CRSC to the proposed change in resources. Submit the form to Ms. Lisa Godin to request any changes in resource needs for your existing approved and ongoing protocol. This is the only way that your CRC resource allocation can be modified.
- Why are my CRC resources only valid for one year (or less)?
CRC conducts an annual review of each project’s CRC resources at the time of the annual IRB continuation. During the month your project is due to expire in IRB, the CRC project review team reviews the status and CRC resource allocation of your project. To assist in that process, CRC reviews your IRB continuation submission. To reduce burden on PIs, CRC may obtain a copy of your IRB continuation submission directly from the UConn Health electronic IRB submission system. Note: this is a new process. In the past, PIs were asked to send the continuation documents electronically to CRC. Once CRC’s review is completed, the PI will receive a letter from CRC indicating either: (1) Renewal of Approval for use of CRC resources for another year (note, some or all previously approved resources may be renewed), or (2) Closure of the project in CRC (i.e., if CRC’s review indicates CRC resources are no longer required for the project).
- What else should I know about the annual CRC review of my project’s resources?
Please be advised of the following important information related to annual CRC reviews:
- IRB approval for continuation: Once you receive IRB approval, please ensure that CRC has an electronic copy of the IRB approval letter. Documentation of IRB approval for continuation must be received in the CRC by the IRB expiration date. Failure to do so will result in a hold on all CRC resources until the documents are received.
- DSMP: Please remember that all studies partially supported by the SAC (i.e., projects that were reviewed/approved by SAC) are required to have a Data and Safety Monitoring Plan (DSMP; Appendix B) approved by the IRB annually.
- Study Closure: Once your study is closed, please ensure CRC receives a copy of the final report submitted to IRB, as well as the IRB’s acknowledgement of study closure.
- My project was approved by SAC. I am submitting a request for modification to the IRB. The IRB modification does not affect my CRC resources. Do I need to inform CRC about this change?
Yes, but CRC will take care of this automatically for you. For SAC-supported projects, it is a CRC requirement that all IRB modifications, even those that do not affect CRC resources, must be reviewed and approved by the CRC Scientific Advisory Committee (SAC). Please ensure the CRC research subject advocate, Ms. Kristen Tremblay, is listed as a contact for your project to ensure CRC receives all IRB correspondence (e.g., IRB modification approvals). Once a project is approved by SAC, CRC will obtain copies of any future IRB submissions directly from the system, as necessary for CRC subject safety and SAC review. Thus, as PI, you do not need to do any extra work.
- What responsibilities do I have as a Principal Investigator using CRC resources?
As the Principal Investigator of your project, you are responsible for timely and complete responses to requests for information (e.g., copies of IRB approvals and continuations, data on subject visits, a progress report, projected resource utilization, publications stemming from the research) for continued CRC support. Failure to promptly provide requested information or documentation could lead to a discontinuation of CRC support. A summary of PI responsibilities is available on the Forms page.
- What is a Projected Utilization report?
CRC asks all PIs to complete a Projected Utilization report each spring. This report asks the PI to project which CRC resources they will need during the upcoming fiscal year. Information provided on this report helps CRC plan for availability of adequate resources for all investigators needing CRC resources in the coming year.
- How does a clinical trial contract impact CRC resources?
For studies with external funding, a final executed contract needs to be in place prior to the CRC providing resources. The contract specialist in the Office of Clinical and Translational Research (OCTR) negotiates ALL clinical trial contracts EXCEPT investigator-initiated federally-funded clinical trial contracts. The Office of Research and Sponsored Programs (ORSP) handles all investigator-initiated federally funded clinical trial contracts.