The successful completion of clinical research is dependent upon an understanding of how healthcare is delivered in the environment where it is conducted. A significant number of clinical studies involve drugs and/or the acquisition of drug concentrations. Clinical Pharmacy Environments is designed for students who do not have clinical pharmacy experience within the U.S. healthcare system. The goal of this course is to improve these studentâ€™s abilities to design clinical/translational research studies by introducing fundamental concepts of how pharmaceutical care is delivered in an US academic health system. To meet this objective, students will gain an appreciation of how pharmaceutical care is delivered through didactic lectures and guided exposures to multiple clinical pharmacy environments with experienced clinical pharmacists. During each field observation, students will be expected to identify the application of pharmacy and therapeutic interventions. Students will also learn how clinical data is generated and stored to deliver daily patient care and how databases may be used for research purposes. Additionally, students are expected to gain an appreciation for the privacy regulations that are associated with accessing protected health information (PHI) for research and their implications for designing and conducting clinical/translational research.
Extract literature from appropriate bibliographic sources.
Critique clinical and scientific evidence derived from literature.
Interpret primary research literature within the pharmaceutical sciences.
Defend the clinical and public health implications of a given research hypothesis.
Design appropriate experiments to address generated research questions in the pharmaceutical sciences.
Evaluate possible problems in the design and execution of a study in the pharmaceutical sciences.
Develop appropriate methods to recruit and retain study participants for a selected research design.
Identify important outcome measures for incorporation into patient oriented clinical trial design.
Generate a plan for data security/management.
Design appropriate, ethically sound, and hypothesis-driven clinical studies.
Identify federal and non-federal agencies and programmatic initiatives aimed at translating research to clinical care of patients.
Defend a written research proposal describing specific research aims, significance, innovation, and approach.
Develop presentations describing proposed research, research in progress, or research findings.
Assess the clinical implications of scientific information.
Demonstrate professionalism, interpersonal skills and collegial approaches to teamwork.
Demonstrate knowledge of the standards of professional and ethical conduct established to guide researchers in protecting the rights, well-being, and dignity in the recruitment and retainment of human subjects in clinical research.
Give examples of the informed consent process including an understanding of the risk/benefit criteria and its impact on the patient/volunteer.
* Highlight denotes properties specific to the Clinical Pharmaceutical Sciences track.