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Decisions

Decisions

The key decisions involved with the set up of investigator-initiated clinical research includes the following:

Funding Resources and Grant Preparation Tools

Funding Resources and Grant Preparation Tools

The Researcher’s Guide provides one-stop shopping for the UW grants process.

The UW School of Medicine’s Grants Review Unit (GRU) is responsible for reviewing all School of Medicine proposals to verify that they comply with the School’s policies and procedures. GRU staff assist with the proposal review process to ensure that proposals are submitted accurately and thereby increasing the chance of funding success.

The UW School of Medicine and the UW Office of Research provide various lists, guides, and other information resources to support the preparation of T32 and other select federal training grants.

The Environmental Health & Services Guide for Principal Investigators outlines your health and safety responsibilities as a Principal Investigator and provides links to related resources. It lists related requirements for grant proposals, purchases and similar actions. It also outlines how to plan for emergencies and disasters.

The Health Sciences Library provides additional tools and services for clinical researchers to help identify funding sources and augment grant proposals. These include translational researcher tools, databases, and Journal and Author Impact Factors.

Feasibility

Feasibility

Before moving ahead with a new clinical research study, assess whether it’s truly feasible for you and your team to conduct the study. Some feasibility considerations are:

  • Ready access to the eligible patient population
  • Necessary facilities and services to conduct the study
  • Time and availability of qualified research team members
  • Sufficient budget to cover all costs
  • Investigator responsibilities
  • Qualifications of investigator and research team members
  • Study objectives, eligibility criteria, patient recruitment, and protocol-required procedures
  • IRB and informed consent requirements
  • Adverse event reporting, source documentation, and recordkeeping practices
  • Space requirements, storage requirements for study products, and availability of required equipment

It may also be helpful to consult with a biostatistician, biomedical informatics consultant, or clinical trials mentoring program to assess feasibility.