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Application Process

Application Process

Applying for CTSI Clinical Services Core Use

The CTSI uses a new electronic resource to facilitate requests for clinical research nursing and space. ProTrackS (Project Tracking System) is a web-based research management system that provides a central portal to researchers and their study teams to browse for research services and submit service and pricing requests from the CTSI. This new platform will allow clinical investigators to self-select requests for CTSI resources across any of our cores, including Clinical Trials Services, Biomedical Informatics Core, Community Collaboration Engagement Team, Population Health Research, Data Science Services, Cellular Translational Research Core, and Precision Medicine.

 

ProTrackS is found at https://protracks.ccts.utah.edu. You may log in with your campus uNID and password to request a Clinical Trials Support - Clinical Services no-fee consultation.

 

Investigators seeking extramural funding should discuss their clinical research nursing and space needs at the earliest planning stages of grant proposal development.

Action Checklist for Accessing the Clinical Services Core

During planning/application stage

  • Access ProTrackS (Project Tracking System) and request a no-fee consultation with the CSC.
  • Arrange for an “Effort Analysis,” which is a budget estimate meeting between the PI/designee and the CSC Nurse Manager, Michelle Adams (801-581-5861). This critical meeting should be held before your budget is submitted, so please plan accordingly.
  • Joint IRB/CTSI application
  • Complete a uTRAC application
  • Contact Investigational Drug Services if applicable
  • After your application receives IRB and IAC approval:

  • Contact your CSC assigned Protocol Manager (PM); A CSC RN assigned by the Nurse Manager at the time of IAC
  • Schedule a Protocol Activation Meeting with your PM (801-581-2224)
  • Complete a Work Authorization in ProTrackS
  • *If your study requires an industry site initiation visit, please make arrangements with the Clinical Nurse Educator
  • Begin scheduling participants IF

  • Your protocol activation meeting has been held
  • You have all action items from the activation meeting resolved to PM satisfaction
  • You have protocol-specific, signed MD orders. Your PM will work closely with your study coordinator to ensure all specific research data points or treatments are described correctly
  • All participants need signed consent/assent documents before any study activity. Email signed copies to CCTSconsents@hsc.utah.edu

What is a Protocol Manager (PM)?

Your Protocol Manager (PM) is your primary contact for any questions and can be reached at 801-581-2224

 

The RN assigned to your protocol will be your Protocol Manager (PM). A Protocol Manager is assigned to each protocol by the Nurse Manager following IAC submission. There may also be a Co-PM assigned to assist. The PM will be your principal contact on the CSC and will work with your team to initiate and conduct the study as designed.

 

Protocol Manager Role & Responsibilities

  • Arrange initial Protocol Activation Meeting (PAM)
  • Coordinate with interdisciplinary teams as needed: ARUP, Investigational Drug Services, etc.
  • Monitor the protocol progress and address/manage obstacles
  • Serve as a primary contact for the protocol
  • Coordinate the development of nursing specific documents and plans
  • Provide mentoring role to study coordinator regarding necessary paperwork, billing, scheduling, and appropriate resources
  • Ensure availability of appropriate equipment for specific protocol requirements