Trial-CARE provides specialized expertise and trial implementation support to faculty who seek to conduct investigator-initiated clinical trials, with a focus on multi-center clinical studies or those trials with more complex elements.

To meet the needs of study teams, Trial-CARE provides multiple tiers of service. In addition to providing initial consultations and focused guidance on study organization, regulatory pathways, budget development, sponsor interactions, and recruitment strategies, Trial-CARE also offers full Coordination Center/Academic Research Organization services to execute trials in partnership with Department-based study teams and investigators.

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

Learn more about our tiers of service.

Offerings:

Support in obtaining external grant funding
  • Assistance in identifying potential funding sources
  • Guidance in developing a study budget and payment structure for a multi-center trial
  • Guidance and templates for developing grant application components for a clinical trial
  • Guidance in managing interactions with governmental and non-governmental sponsors
  • Connection to other University resources that support investigators in building successful grant applications
Template documents
  • Templates for grant sections
  • Templates for protocols and operating manuals for clinical trials
  • Templates for standard operating procedure (SOP) documents for study management functions, data/safety monitoring functions, and ongoing quality monitoring
Regulatory guidance
  • Guidance for faculty in efficiently integrating regulatory compliance considerations into study protocols and trial implementation procedures, with specific consideration of federal agency requirements, University and IRB/HRPO requirements, and PI responsibilities
  • Guidance and support for investigators conducting FDA-regulated research (IND, IDE, or other) that need to meet 21 CFR Part 11 requirements (see our Part 11 Compliant Trial Services for more details)
  • Guidance in planning and implementing multi-center trials that involve a Single IRB
  • Connections to other University resources that offer support in regulatory compliance
Study oversight and monitoring
  • Guidance on Data Safety Monitoring Board (DSMB) organization and management
  • DSMB Executive Secretary services
  • Tools for investigational study drug management and accountability
  • Guidance on best practices for study monitoring and enhancement of site monitoring services
  • Quality Management Plan development and implementation
Protocol development
  • Assist with protocol development, with key considerations for multicenter clinical trials
Recruitment and enrollment support
  • Develop multi-dimensional participant recruitment strategies tailored to your trial
  • Promote accrual of under-represented populations
  • Identify barriers to enrollment, and help solve multi-dimensional accrual challenges
  • Increase enrollment using informatics tools and mobile health tools
  • Connections to other University resources that provide support in recruitment best practices, community outreach, and recruitment material development
Data/Technology management
  • Guidance on development of data management plans
  • Collaboration with the mHealth Research Core to provide guidance for use of remote data capture approaches or consideration for decentralized (site-less) clinical trial development
  • Guidance or development of technology management plans
  • Guidance or development for technology and data flowcharts
  • Part 11 Compliant Trial Services

For any questions about our services, please contact us.