Requests

The OSCAR Program was established to facilitate clinical research in Department of Orthopedics, and strives to meet the research needs of all our investigators. To request services, please submit your request through our request form. You will receive a response within 48 hours.

PRINCIPAL INVESTIGATOR EXPECTATIONS
In order to provide excellent service, The OSCAR Program asks Principal Investigators (PIs) to commit to the following for all human subjects research projects:

  • Provide monthly updates to the OSCAR Research Director
  • Respond within 48 hours to study-related correspondence
  • Schedule and attend regular research team meetings
  • Maintain CITI Human Subjects Protection training

PIs who conduct Sponsor-funded clinical trials must also commit to the following:

  • Complete CITI Good Clinical Research Practice training and adhere to GCP throughout the study
  • Assess Inclusion and Exclusion criteria for all subjects
  • Assess Adverse Events (AEs) for all enrolled subjects, and assess Serious Adverse Events (SAEs) within 24 hours
  • Attend Sponsor meetings, e.g., trainings, site visits, meetings with monitors
  • Review study financial reports on a monthly basis

PROJECT DEVELOPMENT
The OSCAR Program can provide PIs with comprehensive project management expertise, focused on an upstream, proactive planning process to ensure high-quality results.

  • Protocol design and writing for PI-initiated studies
  • Clinical trial budget development and negotiation
  • Standard operating procedures, manual of operations, quality assurance initiatives
  • Liaison for research communications, e.g. IRB, research administration, industry

REGULATORY AND COMPLIANCE

  • Review protocol and develop regulatory strategy
  • Prepare and submit IRB applications, amendments, AE and deviation reports, continuing reviews, and study termination
  • Monitor and improve Good Clinical Research practices
  • Assist with monitoring preparation and audit readiness, as needed
  • Assist in implementing corrective actions, as needed

BIOSTATISTICS AND ANALYTICS
The OSCAR Program staff include a highly-qualified biostatistician, who is available by appointment. A consultation can be requested through the OSCAR Services Request form.

  • Concept development
  • Protocol design and methodology
  • Interim analysis and trial data monitoring
  • Manuscript writing and reviewer response
  • Grant preparation

GRANTS AND FUNDING
The department of Orthopaedic Surgery offers a number of pilot grants, intended for the research and clinical faculty, in the $5,000 to $15,000 range. The grants are administered over a 1-year period and are aimed at generating pilot data for subsequent funding from other sources. Request for proposals are communicated with email in early September of each year, and all submissions are subjected to external reviews to determine funding.

The OSCAR Program works with Orthopedic PIs to match their project and budget to the best funding mechanism and to prepare highly competitive grant submissions.

  • Identify funding opportunities
  • Assist with grant writing and document assembly
  • Assist with CV and NIH/DoD biosketch formatting
  • Prepare and review budget
  • Pre-submission grant application review
  • Provide templates and guidance for applications to common funding agencies, e.g., NIH, OREF, professional societies in orthopedics

STUDY CONDUCT
The OSCAR Program staff include clinical research assistants, clinical trial specialists, regulatory specialists, and program managers who can assist PIs with protocol implementation and conduct.

  • Oversee clinical trial operations
  • Provide day-to-day management of research portfolio
  • Educate and supervise trainees
  • Create patient materials and study documents
  • Screen, recruit, and retain study subjects
  • Database development, data entry, and quality checks
  • Coordinate biological sample collection and processing