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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- 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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- 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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- 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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- 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