Trial-CORE

To meet the needs of study teams, Trial-CORE provides multiple tiers of service. In addition to providing initial consultations and focused guidance on study organization, regulatory pathways, budget development, sponsor interaction and recruitment strategies, Trial-CORE also offers a full suite of management services to execute trials in partnership with the department of Biomedical Informatics, Research Information and Technology and your department-based study teams and investigators.

As needed, investigators will also be connected with resources at the other departments in the College of Medicine and the university to facilitate the success of their studies.

Services Include:

• Protocol Development
  • Assist with protocol development with key considerations for multicenter trials in collaboration with study team and statistician
• Recruitment Guidance and Plans
  • Develop a robust subject recruitment plan focusing on a diverse audience including online and tangible materials
  • Cohort identification with EMR
• Community Engagement Initiatives
• Study Oversight and Monitoring
  • Guidance and or Management of Data Safety Monitoring Board (DSMB) 
  • Independent Quality Checks/Audits
  • Independent Safety Medical Monitoring
  • Clinical Trial Monitoring
  • Tools for Investigative Drug Management and Accountability
  • Quality Management Plan development and implementation
  • Guidance on best practices for study monitoring and monitoring services
• Regulatory Guidance
  • Guidance and support for investigators conducting FDA- regulated research (ex. IND,IDE)
  • Guidance and planning and implementing multi-center trials that involve a Single IRB
• Template Documents and Databases
  • Templates for protocols, databases and operating manuals for clinical trials
  • Templates for standard operating procedures documents for study management functions, data/safety monitoring function and ongoing quality monitoring and management

Trial-CORE consultations and many pre-award activities are subsidized by the Clinical and Translational Science Award (CTSA). Post-award study management services require substantial ongoing effort and collaboration of the Trial-CORE team so would be budgeted into your clinical study grant. The Trial-CORE service model is designed to be flexible. Investigators must meet with the Trial-CORE team directly to discuss the specific need of the study and associated costs.  

Free Consultation

The initial consultation includes an interactive discussion with experienced Trial-CORE professionals about your study. After each initial consultation, faculty members receive written recommendations from our expert support team on key steps that can be taken to move their project forward efficiently. During the Trial-CORE consultation process, we will work with you to determine the Trial-CORE Support Services of best fit for your study. Additional consultation meetings can be scheduled as needed to support the study leading up to implementation of Trial-CORE Support Service.

After the consultation the budget and scope of work will be provided outlining the terms the trial team will assist.