Research Quick Guides
Research Quick guides
This page is dedicated to helping researchers navigate through the University's research pathways.
Investigator Initiated Clinical Trial Lifecycle Quick Steps
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Components
• Develop and design study concept
• Select funding source and review funding requirements (if applicable)
• Identify necessary facilities, equipment, cores, and research support services
• Identify research team, collaborators and stakeholders
• Identify IND/IDE requirements and support (if applicable)
• Identify necessary internal and external reviews (IBC, Research Stakeholders, COI, HISARC, RISST, HBOC, CSRC, etc.)
• Identify database requirements, usage, and storage, and computational systems required for the research. Identify if database
requires 21CFR11 compliance.
• Proactively consult institutional offices (technology commercialization, conflict of interest, research security)
• Budget development (obtain budget estimates from cores, equipment and other research support services)
• Write and refine proposal/project
• Proposal/project submission to funding agency
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Components
• College/Div/Dept pre-review of scientific validity, qualified personnel, and funding source (outside of CCRM & CTO)
• Feasibility study/scientific review (CCRM & CTO)
• Initiate institutional research approvals (e.g., IRB, radiation, biosafety, COI, research data governance committees)
• Refine facilities, equipment, cores and research support services
• Negotiate budgets & execute; navigate contracts and agreements
• Award and subaward setup
• Clinicaltrials.gov registration (if applicable)
• Establish processes for maintaining records, data and project related documentation (e.g., organization of how data and records will
be maintained)
• Site Initiation Visit/Implementation Meeting
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Components
• Clinical Research Conduct (consent, enrollment, intervention, study procedures, follow-up, study completion)
• Principal Investigator oversight of research conduct
• Data Collection and Management
• Maintenance of essential documents
• Project management and reporting to funding agency
• Maintain all required regulatory and institutional approvals
• Regulatory study oversight (e.g., operational, personnel, compliance)
• Financial and contract management
• CT.gov updates and results reporting
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Components
• Accrual and interventions complete (all participants have completed the study)
• Completion of study close out checklists
• Ensure proper storage of research records and samples
• Receipt of all payments
• Prepare final reports
• Analysis and dissemination of results
• CT.gov closeout (if applicable)
• Record storage Translate and commercialize