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Patient Centered Outcomes Research (PCOR): Investigator Initiated Research that compares different medical treatments and procedures to provide evidence on which strategies are most effective in different populations and situations. The goal is to empower with additional information to make sound health care decisions. All PCOR projects require Institutional Review Board approval.

Areas of support / consultation:

Pre-IRB Approval

Post-IRB Approval

Other/Additional

Generating a feasible research question or hypothesis

Patient screening & eligibility

Develop and coordinate grant proposals

Determining appropriate research designs

Patient recruitment & consent

Various research presentations

Statistical plans

Data coordination & collection

Attendance at journal clubs, committees, & councils

Sample size and power calculation

Statistical analysis & interpretation

Transform evidence based and quality projects into research

IRB process
(consultation and review)

Poster development

 

Manuscript development and dissemination

Critical evaluation of investigator presentations, posters, & manuscripts


Clinical Trials Research (CTR): The controlled clinical testing of investigational new drugs, devices, treatments, or diagnostics: or comparisons of approved drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes, if any, in human subjects. Such studies may be conducted under either a sponsor-developed or an investigator-developed protocol. These studies are conducted in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration, under Phase I, II, III, or IV.

Areas of support / consultation:

Pre-IRB Approval

Post-IRB Approval

Feasibility assessment

Coordination of site Initiation, monitoring & close out visits

Regulatory & IRB application submission

Patient screening & eligibility

Study billing compliance

Patient recruitment & consent

Pharmacy & lab coordination
(if applicable)

Data collection & coordination

Radiology & imaging coordination
(if applicable)

Coordination of specimen collection & shipping

Pharmacy & Lab Coordination

Radiology & Imaging Coordination (if applicable)


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