CTO Core Teams

The clinical trials office consists of three core teams:

Regulatory Affairs

The Regulatory Affairs team of the CTO provides regulatory services that include:

  • Preparation of any Pre-Site Selection Surveys with Investigators
  • Site Qualification Visits
  • All IRB Submissions which includes:
    • Completing the appropriate paperwork
    • Preparation of the Informed Consent Forms
    • Submitting new IRB applications
    • Continuation Reports
    • Revisions and Amendments
    • Final reports
    • Protocol deviations
    • Serious adverse events
    • Advertising/ recruitment materials
  • Submitting the initial regulatory packet to the sponsor, this includes, but is not limited to the following:
    • 1572 form
    • CV's and licenses for the Principal Investigator and all Sub-Investigators
    • Local laboratory CLIA and CAP
    • Lab director's CV and license
    • Delegation of Authority Log
    • Other sponsor specific regulatory requests

Once a study has begun the team is responsible for ongoing maintenance and compliance with the federal regulatory requirements. They work closely with study sponsors to maintain the regulatory binder and handle all regulatory requests throughout the course of the study.

Financial Management

The Financial Management aspects during the lifecycle which requires oversight of a clinical trial include the following:

  • Completing the appropriate paperwork
  • Coordination of Confidentiality Agreements
  • Budget Analysis
  • Study budget preparation and negotiations
  • Facilitate Contract Negotiations
  • Grant start-up (opening a grant)
  • Ongoing management of the study grant with Sponsored Projects, Division Administrators & DOM
  • Monthly Invoicing to the sponsor
  • Facilitate and Contract Amendments as they may arise during the course of a study
  • Monitoring of grant expenses
  • Patient care costs
  • Payments for ancillary services performed during the study
  • Check requests for patient stipends, etc.

Clinical Coordinators

The Clinical Research Coordinators assist the investigators by providing accuracy and compliance for current clinical studies. The coordinators work closely with the investigators in confirming eligibility requirements for patients, educating patients about protocol requirements, following patients on study protocols, and completing precise data collection and entry.

  • Working with regulatory for Site Readiness
  • Attending investigator meeting(s)
  • Preparing for study initiation
  • Work with Investigators for Recruiting subjects
  • Screening and scheduling subjects
  • If delegated, ensure proper Informed Consent Documentation and Process      
  • Teaching subjects about protocol expectations for them
  • Performing study/protocol procedures in a detailed, accurate manner                          
  • Entering subject data and answering queries
  • Maintaining study files
  • Tracking subjects, avoiding lost-to-follow-up
  • Documenting adverse and serious adverse event(s), including:

CTO Process Overview