Frequently Asked Questions
Your Go-To Resource for Utah DCC Questions
Q: How do I know if I need the Utah Data Coordinating Center (DCC)?
A: The Utah DCC typically helps investigators and sponsors with multicenter trials and studies. Our comprehensive staff and faculty expertise cover study needs in statistics, data management, project management, IT, data transfers, and/or innovative solutions.
Q: When should I reach out to the Utah DCC?
A: The earlier, the better! Often, our help is most valuable as you are planning your study. Early intervention and partnership can reduce costs and maintain scope and feasibility. Our team offers creative solutions for designing your protocol from a statistical, data management, site management, and regulatory perspective.
Q: My grant is already funded. Can I still reach out to the Utah DCC?
A: Yes, you can reach out to us anytime. Sometimes, there are creative ways to address the funding issues.
Q: I already have a data management plan using REDCap. Can the Utah DCC still help me?
A: There is some overlap in the services offered by the Utah DCC and the Utah Clinical & Translational Science Institute (CTSI). The Utah DCC typically manages larger multicenter trials and studies or can help with development of these types of projects. Early study development phase projects may sometimes benefit from a Design Studio consultation with the Utah CTSI. If you are uncertain, please reach out to us.
Q: I am already working with the Biomedical Informatics Core (BMIC) or the Study Design & Biostatistics Center (SDBC) at the University. Do I need the Utah DCC?
A: Probably not. These groups provide excellent services. You likely do not need to work with the Utah DCC unless there are complex pieces or additional study requirements.
Q: Why should I work with the Utah DCC?
A: The Utah DCC has a 20-year history of designing, developing, implementing, and publishing results from national and international multicenter studies in both industry and academic settings. Partnering with investigators, we also have a very successful funding track record. Our team has extensive IT expertise which helps us support decentralized trials, complex data transfer, texting solutions, image upload, data transmission from mobile health devices, digital health solutions, and in some cases, EHR data transfers.
Q: How do I know if I need the Utah Data Coordinating Center (DCC)?
A: The Utah DCC typically helps investigators and sponsors with multicenter trials and studies. Our comprehensive staff and faculty expertise covers study needs in statistics, data management, project management, IT, data transfers, and/or innovative solutions.
Q: When should I reach out to the Utah DCC?
A: The earlier, the better! Often, our help is most valuable as you are planning your study. Early intervention and partnership can reduce costs and maintain scope and feasibility. Our team offers creative solutions for designing your protocol from a statistical, data management, site management, and regulatory perspective.
Q: My grant is already funded. Can I still reach out to the Utah DCC?
A: Yes, you can reach out to us anytime. Sometimes, there are creative ways to address the funding issues.
Q: I already have a data collection plan and/or I already have statistical or clinical coordinating center (regulatory) resources. Can the Utah DCC still help me?
A: Yes, it may still be possible for our team to assist you. Please reach out to us. We do offer 'menu-driven' services so that investigators can choose the services that they need.
Q: Why should I work with the Utah DCC?
A: The Utah DCC has a 20-year history of designing, developing, implementing, and publishing results from national and international multicenter studies in both industry and academic settings. Partnering with investigators, we also have a very successful funding track record. Our team has extensive IT expertise which helps us support decentralized trials, complex data transfer, texting solutions, image upload, data transmission from mobile health devices, digital health solutions, and in some cases, EHR data transfers.
Q: I have an NIH-funded or NIH application trial. I am interested in learning if the Utah Data Coordinating Center (DCC) could support my study.
A: The Utah DCC is a full-service Academic Research Organization (ARO) that operates a comprehensive Clinical Coordinating Center (CCC) as well as a Data Coordinating Center (DCC). We provide comprehensive support for many types of trials. Our team has expertise in site management, Single IRB, FDA-regulated trials, and we have successfully worked with many NIH institutes. We can manage your entire project as your DCC partner or we can collaborate with another Clinical Coordinating Center and solely provide data and statistical support.
Q: What are the first steps?
A: The Utah DCC process initially includes a brief introductory meeting to determine if our services are a good match for your needs. We request that you provide us with a summary of your protocol, state of development, budget, timeline, and other basic information.
Q: I am not a part of the University of Utah and the University of Utah is not going to be one of our enrolling sites. Can I still use the Utah DCC to run my trial?
A: Yes, the Utah DCC can serve as the DCC and/or the CCC for your study, even if the University of Utah isn't one of your enrolling sites.
Q: How can the Utah Data Coordinating Center (DCC) help me with my trial?
A: The Utah DCC can support industry sponsors throughout all phases of their clinical studies. Our staff and faculty expertise can provide comprehensive support for study design, sample size calculations, protocol writing, site identification, IRB submissions, database design and build, data management, project management, monitoring, innovative IT solutions, data transfers, analysis, manuscript statistical support, and clinical study report writing.
Q: When should I reach out to the Utah DCC?
A: The earlier the better! Often, our help is most valuable as you are planning your study. Early intervention and partnership can reduce costs and maintain scope and feasibility. Our team offers creative solutions for designing your protocol from a statistical, data management, site management, and regulatory perspective.
Q: I have already begun my study and have enrolled participants. Can the Utah DCC still help me with running my study?
A: Possibly – please reach out to us! We do offer ‘menu-driven’ services so that sponsors can choose the services that they need.
Q: I have an in-house clinical team to manage the study, but need help with my database. Can the Utah DCC help me?
A: Yes, the Utah DCC can provide data coordinating center (DCC) services, clinical coordinating center (CCC) services, or both. We are happy to partner with your in-house team.
Q: My project requires a validated database. Can you help me?
A: Yes! The Utah DCC has a 21 CFR §11 validated REDCap instance that we can use for your FDA-regulated trial.
Q: Why should I work with the Utah DCC?
A: The Utah DCC has a 20-year history of designing, developing, implementing, and publishing results from national and international multi-center studies in both industry and academic settings. Our team has extensive IT expertise which helps us support de-centralized trials, complex data transfer, texting solutions, image upload, data transmission from mobile health devices, digital health solutions, and in some cases, EHR data transfers. Our home in an academic medical center positions us to deliver comprehensive clinical research solutions.
Q: Does the Utah Data Coordinating Center (DCC) provide standalone services in statistical related work (e.g., DSMB, statistical analyses, statistical design)?
A: The Utah DCC has eight faculty statisticians and more than 20 Masters-level statisticians. This group has extensive expertise in:
- Study design
- Preparing DSMB materials
- Leading DSMB meetings
We can also assist with analyses, randomization design, publications, and other statistical work.
Q: Does the Utah DCC assist with study protocol development?
A: Yes, study design development and protocol writing is one of our strengths! We have expertise in developing feasible, executable protocols and grants. While we prefer to partner with you early in the protocol development process, we can also partner later in the process as well. We can help you with implementing the protocol at your study sites.
Q: I have already begun my study and have enrolled participants. Can the Utah DCC still help me with running my study?
A: Possibly- please reach out to us! We do offer 'menu-driven' services so that investigators can choose the services that they need.