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|Principal Investigator/Program Director (Last, First, Middle): |. |

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|RESOURCES |

|FACILITIES: Specify the facilities to be used for the conduct of the proposed research. Indicate the performance sites and describe capacities, pertinent |

|capabilities, relative proximity, and extent of availability to the project. If research involving Select Agent(s) will occur at any performance site(s), the|

|biocontainment resources available at each site should be described. Under “Other,” identify support services such as machine shop, electronics shop, and |

|specify the extent to which they will be available to the project. Use continuation pages if necessary. |

Clinical:

The Institute for Clinical Translational Sciences (ICTS, supported by NIH through a Clinical Translational Sciences Award) at UC Irvine is located on both campuses: at the UC Irvine Medical Center in Orange and at the main campus, in Irvine, within Hewitt Hall. The ICTS facilities include all administrative staff, stations, nursing, exam rooms, and support necessary for the full range of patient for clinical research. The ICTS nursing staff consists of a team of experienced, dedicated nurses who are specifically trained in assisting research teams to carry out approved research protocols, while providing research participants with the highest standards in quality of care. Ancillary services of the ICTS are many and include phlebotomy and laboratory assessments for clinical trial participants.

The Center for BioMedical Informatics (CBMI) in the ICTS provides investigators with expertise in state-of-the-art clinical data warehouse mining, current tools for interoperability in multicenter trials, and expertise in “honest broker” approaches toward research subject confidentiality and data protection. An additional strength is the expertise in the emerging discipline of the Science of Team Science, which is focused on the informatics and interface tools that promote multidisciplinary, collaborative, biomedical research endeavors. The CBMI is fully integrated with the Health Affairs Information Systems at the UC Irvine Medical Center as well as with the Donald Bren School of Information and Computer Sciences at UC Irvine, and will be providing bioinformatics support for the proposed study.

Biostatistics, Epidemiology, and Research Design (BERD) Unit of the ICTS provides biostatistical collaboration and education. BERD provides both short- and long-term collaboration for investigators. Consultations can be used for any range of research related writings or applications including grant proposals, study design, power and sample size calculations, IRB applications, etc.

The Accrual and Retention Unit of the ICTS is specifically formed to support investigators in ensuring optical recruitment and retention for their studies. This service is available for both junior and senior investigators, for studies at any stage from grant application to active enrollment. The unit is available to assist in designing studies for maximal success in relation to subject accrual and retention; for matching investigators with the community, other faculty, or other experts in this domain; and consultation for ongoing studies that are experiencing difficulty with recruitment or retention.

The Team Science Unit helps support clinical translational science by creating new cross-campus synergies. It also provides training to individuals for improving methods and processes in clinical translational science as well as a nurturing environment for the development of T- and K-awardees through funding, mentorships, and education. The goal of the Team Science Unit is to develop new methodologies in clinical and translational research by generating and disseminating new knowledge and practices related to team science.

The Community Engagement Unit (CEU) of the ICTS engages the community in translational research as active partners and serves as an incubator for new ideas and approaches to clinical translational science. The CEU co-leads the Community Health Research Exchange and funds 5-8 Campus-Community Research Incubator research grants annually. The main goals of the CEU are to collaborate with other ICTS Units and with other groups across campus in order to foster innovative approaches for engaging communities and stakeholders, training the ICTS workforce in community-engaged research, and integrating special/underserved populations in translational research.

The Informatics Unit of the ICTS supports additional uses of clinical data for research by providing investigators with HIPAA-compliant clinical data. The Informatics unit is UCI’s IRB-certified Honest Broker & Data Steward and can fulfill data requests for IRB-approved protocols. They provide training and consultation for various tools including My Research Portal, REDCap, UCReX Data Explorer, and OnCore Clinical Trial Management System (CTMS).

The ICTS Pilot Program provides funding opportunities throughout the year in order to address a wide range of research and process challenges faced in translational science. There is an online pre- and post-grant award process to assist with grant application, review, and tracking progress.

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