Radiology Clinical Research Core

Services

Coordination & Recruitment

  • Coordination of funded research: federal, industry or department funded research
  • Pre-study start up activities: preparation, collection and completion of requested forms.
  • Complete site verification forms, 1572, CDA, liaison with JROC for contract negotiations
  • Participate in conference calls and study meetings as needed
  • Site initiation visits: in-house as well as attendance at investigator training sessions
  • Expertise in common imaging modalities: CT, MRI, X-ray, mammography and sonography
  • Services available for experimental technologies, device interventions, and diagnostic tools
  • Budget preparation and negotiation with sponsors. Work closely with PI, ORSR, or CCS as needed
  • Protocol review/edit as needed
  • Case Report Form (CRF) design
  • Identify needed collaborators
  • Arrange and schedule pre-study visits
  • IRB (HRPO) – new submissions, renewals, amendments, study closures
  • Inform Consent review and editing.
  • PRMC and RDRC assistance
  • FDA (IND/IDE) support
  • Eligibility screening, recruiting, enrolling/consenting and long-term follow-up.
  • Coordination of study visits, procedures and compliance checks.
  • Large study recruitment efforts utilizing advertising and multimedia resources.
  • Tracking and monitoring of study participants: follow-up visits, reminder notifications, additional triggers for subjects lost to follow-up, survey/questionnaire, etc.

Imaging and Response Assessment Core (IRAC)

Our primary objective is to facilitate the use of anatomical and molecular imaging methods for assessment of tumor biology and response to therapeutic interventions in cancer clinical trials.

  • Protocol development and review, specification of imaging parameters to be used in clinical trials
  • Coordinator support of imaging studies to ensure protocol compliance, quality control of images, and qualitative and quantitative analysis of the resultant imaging studies. 
  • IRAC will investigate novel software tools for image evaluation.
  • IRAC will maintain data repositories that permit imaging data to be used for secondary studies.
  • IRAC will integrate new, advanced image analysis methods into the tumor imaging and measurement service, e.g., tumor volumetric measurement and newer PET radiopharmaceuticals. 
  • Expert consultation on how to integrate imaging into research study designs and protocol development.
  • Assistance in identifying the image response assessment criteria and personnel support.
  • Maintenance of site qualification for cooperative group and industry-sponsored multicenter clinical trials.
  • Services required for execution of specialized imaging examinations.
  • Coordination of activities and reporting, including data management and routing to appropriate workflow lists.
  • Measurement of tumor response by a trained radiologist/nuclear medicine physician or by a trained technologist with oversight and sign-off by an IRAC radiologist/nuclear medicine physician.
  • ervices include protocol development and review, specification of imaging parameters to be used in clinical trials, coordinator support of imaging studies to ensure protocol compliance, quality control of images, and qualitative and quantitative analysis of the resultant imaging studies. 
  • IRAC will investigate novel software tools for image evaluation.
  • IRAC will maintain data repositories that permit imaging data to be used for secondary studies.
  • IRAC will integrate new, advanced image analysis methods into the tumor imaging and measurement service, e.g., tumor volumetric measurement and newer PET radiopharmaceuticals. 
  • Expert advice on how to integrate imaging into research study designs and protocol development.
  • Assistance in identifying the image response assessment criteria and personnel support.
  • Maintenance of site qualification for cooperative group and industry-sponsored multicenter clinical trials.
  • Services required for execution of specialized imaging examinations.
  • Coordination of activities and reporting, including data management and routing to appropriate workflow lists.
  • Measurement of tumor response by a trained radiologist/nuclear medicine physician or by a trained technologist with oversight and sign-off by an IRAC radiologist/nuclear medicine physician.
  • Pre-study start up activities; preparation, collection and completion of requested forms.
  • Complete site verification forms, 1572, CDA, liaison with JROC for contract negotiations
  • Participate in conference calls and study meetings as needed
  • Site initiation visits; in-house as well as attendance at investigator training sessions
  • Expertise in common imaging modalities; CT, MRI, X-ray, mammography and sonography
  • Services available for experimental technologies, device interventions, and diagnostic tools
  • Budget preparation and negotiation with sponsors. Work closely with PI, ORSR, or CCS as needed
  • Protocol review/edit as needed
  • Case Report Form (CRF) design
  • Identify needed collaborators
  • Arrange and schedule pre-study visits
  • IRB (HRPO) – new submissions, renewals, amendments, study closures
  • Inform Consent review and editing.
  • PRMC and RDRC assistance
  • FDA (IND/IDE) support
  • Eligibility screening, recruiting, enrolling/consenting and long-term follow-up.
  • Coordination of study visits, procedures and compliance checks.
  • Large study recruitment efforts utilizing advertising and multimedia resources.
  • Tracking and monitoring of study participant; follow-up visits, reminder notifications, additional triggers for subjects lost to follow-up, survey/questionnaire, etc.

Operational Services

  • Scheduling enrolling, consenting and long-term follow-up
  • Specimen collection, processing and shipping, EKG, vital status
  • Transferring de-identified images electronically to secure sponsor-identified resource
  • Retrieving and burning images for transfer to core labs and central data coordinating centers
  • Data entry and tracking of forms: web-driven and hard copy as requested; customized spreadsheet, data mining and repository services
  • CRF completion, source documentation and report capture
  • Continual protocol review, development, amendments and implementations
  • Protocol-specific quality assurance activities
  • Study drug administration
  • Coordination of sponsor and medical monitor visits during ongoing trials as well as close-out visits

Budget & Billing Support

  • Continual budget review and negotiation with sponsors as changes occur
  • Grant budget monitoring, reporting and accounting of funds
  • Research professional pricing, establish exam codes and provide research quotes
  • Billing and invoicing for professional services provided by diagnostic faculty
  • Manual billing and online billing when managed department-to-department
  • Internal audit review; project status, ad hoc CRF review, and project projections
  • Grant services, including writing, editing, budgeting and project design
  • Assistance on future funding opportunities ranging from pilot to R01 level funding mechanism

Contact Us

If you have any questions or would like more information, email Greg Williams.

FAQ

Helpful and important information about what we do and the services we offer.

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