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Clinical & Translational Science Institute / Browse by / Browse by Project Phase

 

Browse by Project Phase

This page provides descriptions of resources that can help you with each stage of your research project.

This section provides education and training available to faculty, trainees, and staff. Some training is required depending on the research activity you are performing.

  • Office of Research Project Administration (ORPA)
    • Researchers
      • Training for researchers provides an overview of topics related to the conduct and administration of research.
    • Department Administrators
      • Department Administrator training includes Continuous Learning for Administrators of Sponsored Programs (CLASP).  CLASP is required for anyone having an ability to originate, authorize or approve transactions associated with sponsored programs; involvement with proposal preparation; or active review and monitoring of the financial activities of sponsored project accounts.
  • Office of Human Subject Protection (OHSP) Research Education & Training
    • The purpose of OHSP education and training is to assist researchers in protecting the rights, welfare and safety of human subjects by providing educational opportunities and resources in research ethics and human subject safety, with an emphasis on proper and responsible conduct of human subject research.
      • The OHSP Education and Training Framework assist Researchers, Research Staff, Department Chairs, Administrators and other Senior Leadership within the University of Rochester (UR) in navigating the research training requirements, opportunities and framework set forth by the Office for Human Subject Protection’s (OHSP) Division of Research Education & Training.
      • Human Subject Protection Training (CITI) OHSP requires all study team members to successfully complete human subjects training through an on-line program called the Collaborative Institutional Training Initiative (CITI Program) prior to conducting any human subject research. Training must also be renewed every 3 years to continue conducting human subject research.
      • Good Clinical Practice (GCP) Training (CITI) Study team members wishing to complete GCP training, in addition to human subjects training, may do so via the Collaborative Institutional Training Initiative (CITI). While this training is not required by the University, it may be required by sponsors and/or funding agencies (see information below regarding National Institutes of Health GCP training requirements).
      • Click® IRB Training & Support Training and support materials for utilizing Click® IRB is the platform used to facilitate review of research by the Research Subjects Review Board. This website provides user manuals, information on open office hours and demonstration videos.
  • OnCore Training
    • OnCore is URMC’s clinical trial management system.
  • University Committee on Animal Resources (UCAR)
    • UCAR reviews and approves all research involving animals.  UCAR requires you complete training before working with animals in the lab and/or to gain access to the Vivarium.
  • Environmental Health and Safety (EH&S)
    • Laboratory Safety Training This training is in MyPath.  Please choose the course that most accurately describes the materials that you handle within your duties. If you are unsure of the course to take, please ask you Principal Investigator or Supervisor. All courses include Bloodborne Pathogens Training.
    • Radiation Safety (Log in Required) The Radiation Safety Unit has developed a training program for users of radioactive material and for individuals working in an ancillary capacity. All prospective users of radioactive material must take the online training course and pass the test to become fully certified as an Authorized User at the University of Rochester.
  • eRecord (Log in Required)
    • Visit this site to sign up for eRecord training and access the class schedule. There are in-person and online trainings.
  • Office of Regulatory Support
    • The Office of Regulatory Support (ORS) offers services to support investigators with the submission of Investigational New Drug (IND) and Investigational Device Exception applications to the FDA.
  • Early Stage Faculty Boot Camp
    • Early Stage Faculty Boot Camp is designed to help Senior Instructors and Assistant Professors identify the skills they need for more successful career advancement.
  • Career Engagement, Revitalization and Transition
    • This course is designed to help associate professors and professors identify additional resources and further develop necessary skills as they advance through the phases of their academic careers.
  • SCORE
    • SCORE provides support and regular networking opportunities to University research coordinators and staff.
  • CLIC
    • The Center for Leading Innovation and Collaboration (CLIC) provides a variety of education and career development resources.

The first step to a successful research project is the development of the research concept and a funding application.  These resources will help you identify a research problem, develop the methods to answer your hypothesis and accelerate the development of your research plan.

  • Research Methods Forum
    • The Research Methods Forum provides an interactive setting for investigators to present new and developing research ideas to multidisciplinary experts in clinical research methods and potential collaborators, who will provide recommendations.
  • The Trial Innovation Network
    • The Trial Innovation Network connects CTSA Program Hubs nationwide to leverage their expertise and resources to conduct large, multi-site clinical trials.
  • Center for Data to Health (CD2H)
    • CD2H accelerates advances in informatics by promoting collaboration across Clinical and Translational Science Awards (CTSA) Program hubs, including the University of Rochester.
  • National COVID Cohort Collaborative (NC3) Domain Teams
    • ​N3C enables researchers with shared interests to collaborate more efficiently and analyze data within the N3C Data Enclave, a secure platform housing harmonized COVID clinical data.
  • ROC Health Data
    • Health researchers and community partners can map local health outcomes and social determinants of health using the Roc Health Data website.
  • Literature Searches
    • Edward G Miner Library: To initiate a literature search, stop by the Reference Desk, give us a call at (585) 275-2487, or submit a literature search request through Ask A Librarian. A standard search is usually completed in 4-5 working days and there is no fee for UR affiliates.
  • Patient Cohort Discovery
    • TriNetX
      • Search UR Medicine’s health records to get counts of patients with particular inclusion/exclusion criteria.
    • ACT Network
      • The ACT Network is a real-time platform allowing researchers to explore and validate feasibility across the CTSA institutions for multi-site clinical studies.
  • ​CTSI Consultations
    • The UR CTSI provides funding, education, resources and services to help research teams collaborate and produce results faster. Through our many programs, we strive to advance science and medicine and improve the health of communities and populations. Submit a request online for assistance.
      • Participant Recruitment and Retention
      • Greater-Rochester Practice-Based Research Network
      • UNYTE Research Network
      • Community Engagement
      • Informatics
      • Digital Health and Regulatory Science
      • Equity-Focused Dissemination and Implementation
  • Research Data Integration and Analytics
    • The Research Data Integration and Analytics (RDIA) group is a team of experienced database developers, data managers and statisticians that provide integrated research study and experimental data management.
  • Bio-Laboratory Informatics System (BLIS)
    • BLIS is a data integration and management system that can integrate clinical, specimen inventory, experimental assay data.
  • URVentures
    • URVentures protects, develops, and commercializes the intellectual property (IP) arising from research at the University of Rochester.  Before embarking on a project, be sure your IP is protected.
  • Office of Regulatory Support
    • The Office of Regulatory Support (ORS) offers services to support investigators with the submission of Investigational New Drug (IND) and Investigational Device Exception applications to the FDA.
  • Biostatistics Consulting Service
    • The Department of Biostatistics and Computational Biology of the School of Medicine and Dentistry offers a statistical consulting service to support faculty and non-faculty researchers of the Medical Center, as well as investigators outside the Medical Center who require help with projects and grant preparation, depending on the staffing level and the mutual interest between statisticians and investigators. Services range from purely advisory assistance to complete statistical analysis as well as support for data management. Charges for statistical consulting, programming and data management support, and computer usage are billed to investigators using established hourly rates.
  • CTSI Regulatory Science
    • The FDA defines Regulatory Science as "the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products." The UR CTSI has launched a range of programs focused on advancing training, career development and research in Regulatory Science.
  • UR Health Lab
    • UR Health Lab is transforming the way data science is being used in medicine by developing novel tools that capture new data streams, analyze previously unseen patterns and enable health care providers to provide individualized treatments that are more responsive, effective and precise.
  • Center for Health & Technology (CHET)
    • The Center for Health + Technology (CHeT) is a clinical research organization within the University of Rochester with expertise in clinical trials coordination, clinical trials supply services, patient-reported outcome measures, research using novel technologies, and data modeling and predictive analytics. CHET houses the Clinical Trials Coordination Center and the Clinical Materials Services Unit.
  • Center for Advanced Research Technologies (CART)

    • The Center for Advanced Research Technologies (CART) is a collection of core facilities within URMC that share resources and expertise with our 3,000+ researchers and 500+ labs, and with principal investigators both inside and outside URMC. We provide the equipment, personnel, and analysis to move your research forward.

  • ORPA Proposal Development
    • All funding proposals need to be submitted through ORPA.  They provide a list of necessary information for proposal submission.  Investigators need to work with their department administrator and ORPA representative to submit proposals that meet all funder requirements.
  • ORPA Award Management
    • Once a proposal has been funded and an official notification of the award (e.g., Notice of Grant Award, letter of award, fully executed contract) has been received from the sponsor, ORPA will issue a Financial Activity Object (FAO) for the project.  This website provides information you need to fulfill the terms of the award.
  • Research Subject Review Board
    • The RSRB reviews research that is conducted or supported by the University of Rochester.  Their website provides all the policies, guidelines and resources you need to submit an application through the Click IRB.
    • Find out who is your IRB Coordinator.
  • Office of Clinical Research
    • The office of Clinical Research (OCR) supports the administration of clinical trials through the use of the clinical trials management system, OnCore.  They also provide financial support, negotiating budgets and invoicing sponsors, for a fee.
  • ClinicalTrials.gov
    • The Office of Regulatory Support (ORS) offers services to support research teams with registration and reporting of clinical research trials at ClinicalTrials.gov.
  • Participant Recruitment and Retention
    • The UR CTSI provides several tools and resources to help you successfully recruit and retain research subjects including the CTSI Research Participant Registry, ResearchMatch.org, MyChart for Recruitment, Facebook advertising and consultations.
  • Get eRecord Access (Log in required)
    • Visit this website for instructions on how to request eRecord access.
  • REDCap
    • REDCap is a secure web platform for building and managing online databases and surveys.
  • URMC Clinical Lab Services
    • UR Medicine Labs is a full-service, not-for-profit laboratory that can assist with testing for your research project.
  • Vivarium
    • The Vivarium is a service department of the School of Medicine and Dentistry (SMD). The Vivarium provides for the procurement, housing, and care of the laboratory animals. Facilities are available to investigators for major surgery, post-operative care, radiology, and necropsy. The Vivarium also provides housing and care for animals in studies using radioisotopes, infectious agents up to ABSL III level, chemical carcinogens and other hazardous substances. Specialized resources include a human xenograft facility, a transgenic core facility, and a hazardous substance laboratory.
  • EMBARK/OnCore
    • The OnCore clinical trial management system is industry-leading software that streamlines much of the administrative work behind a clinical trial.
  • OHSP Research Quality Improvement
    • OHSP QI staff will audit your study to make sure your documentation follows required regulations.  Get an audit at the before you start your study or in preparation for a FDA audit.
  • OCR Participants Payments
    • Participant Payments is a safe, secure automated system that helps immediately pay subjects after each clinical study visit using a reloadable card.  
  • HIPAA (log in required)
    • This website contains policies, plans, guidelines and training related to HIPAA.
  • Clinical Research Center
    • The Clinical Research Center (CRC) provides an optimal setting for medical investigators to conduct safe, controlled, inpatient and outpatient studies of both children and adults.
  • Clinical Trials Coordination Center (CTCC)
    • The CTCC, part of CHET, operates to foster multi-institutional academic research through the development, management, and reporting of hypothesis-driven, controlled clinical trials.  The CTCC can provide data coordination center services for a fee.
  • The Clinical Materials Services Unit (CMSU)
    • The CMSU, part of CHET, provides contract pharmaceutical services to the Clinical Trials industry. The CMSU is registered with the New York State Board of Pharmacy as a wholesaler re-packager of drugs and devices. Core services include: secondary packaging, primary labeling, blinding, distribution, and return services, as well as regulatory support and production of clinical labels.
  • Shared Resource Labs
    • The Shared Resource Laboratories provide an extensive spectrum of trained personnel, innovative, leading edge services and instrumentation to all researchers at the University of Rochester School of Medicine and Dentistry.  Shared Resource Labs provides access to the Biosafety Level 3 facility (BSL-3), Center for Advanced Light Microscopy and Nanoscopy, Electron Microscopy Resource, Flow Cytometry Resource, Genomics Research Center, Mass Spectrometry Resource, Multiphoton and Analytical Imaging Center.
  • Office of Research Accounting and Costing Standards (ORACS)
    • The mission of the Office of Research Accounting and Costing Standards is to maintain and continuously enhance an effective management system to monitor financial compliance required by Federal, State, and Local Governments, private agencies, and foundations for all sponsored programs awarded to the University of Rochester.  We will achieve this by providing comprehensive and timely customer service to our PI’s, Administrators, Sponsors and support staff as well as the Central Office’s that rely on costing and other financial data to make University-wide operational decisions.
  • Clinical Trials Processing Lab
    • The Clinical Trials Processing Laboratory (CTPL) has 25 years of experience in providing laboratory support to investigator-initiated clinical trials. The CTPL is a fee-for-service core resource that supports human clinical trials and basic science research conducted within the University of Rochester. The laboratory provides technical services including: Processing of blood and tissue samples for PI-initiated, pharmaceutical, and NIH-funded clinical trials and Shipment of specimens according to study protocols.
  • Emergency Department Research Associate Program (EDRA)
    • The EDRA Program is a valuable resource allowing researchers access to a substantial and diverse patient population in the Emergency Department. There are fees associated with utilizing the EDRA Program for subject identification and enrollment.
  • ORPA for project closeout
    • Both during and upon the completion of the sponsored award, the University must fulfill the requirements outlined in the terms and conditions. Researchers should engage ORPA to ensure projects are closed correctly.
  • Dissemination of Results
    • Sharing results with the scientific community, participants and the community-at-large is an essential step in the research project life cycle.
      • The Miner Library can assist with scientific publication.
      • The CTSI can review drafts of study results meant for participants and the community.
      • Public Relations can assist with disseminating your results to the community.
  • Clinicaltrials.gov
    • FDAAA and the NIH requires reporting of study results no later than 12 months after the completion of the study.
  • CLIC Career Development Communities
    • An interactive space available where individuals can collaborate, network, and share ideas with their peers from across the consortium. There is a community for TL1 scholars, KL2 scholars and clinical research professionals.
  • UR Connected (log in required)
    • The UR CTSI's UR Connected tool can help researchers in need find qualified, available research coordinators.
  • SCORE
  • The CTSI Weekly Update
    • It provides information about events and opportunities in clinical and translational science for collaboration, career development, and funding. Subscribe here.
  • The Research Request Dashboard
    • Have a research-related question or need assistance with the planning or conduct of your study? Visit the Research Request Dashboard and enter your question to receive support.
  • OHSP Email Distribution List
  • ORPA Email Distribution List
    • The ORPA-L is a listserve used to announce important information and notices related to research administration. To subscribe to the ORPA-L, send a message via the feedback form and include your email address in the message.