INTRODUCTION TO CLINICAL AND HEALTHCARE RESEARCH II
Practical training and skills required in clinical and healthcare research; design, implementation, and conduct of clinical trials and health services research studies; protocol and informed consent development using protocol templates; regulatory requirements; human subjects research protections considerations; data and safety monitoring plans; data collection strategies and data management; strategies to recruit/retain diverse and equitable study participants; research study agreements; budget development and justification; federal, institutional, and sponsor-defined requirements; establishment of research infrastructures for participant safety and study success; preparation of investigator-INDs/IDEs; and investigator responsibilities.
Prerequisites & course information
Requisites: STAT/B M I 542 Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Fall 2023 Learning Outcomes: 1. Apply applicable legal and regulatory responsibilities, liabilities, and accountabilities for clinical trials and health services research studies according to IRBs, HIPAA, CGP, FDA, NIH, ClinicalTrials.gov, and other applicable entities Audience: Graduate 2. Apply and implement best practices for human subjects’ protection Audience: Graduate 3. Apply team science through working with multidisciplinary and interprofessional team Audience: Graduate 4. Analyze requirements in conduct of a clinical trial or health services research study and implement the use of a protocol to standardize procedures Audience: Graduate 5. Evaluate and select data collection processes and implement quality control and assurance processes Audience: Graduate 6. Create a protocol and consent/assent processes and documents for a clinical trial or health services research study, as well as supportive components Audience: Graduate Learning Outcomes: 1. Apply applicable legal and regulatory responsibilities, liabilities, and accountabilities for clinical trials and health services research studies according to IRBs, HIPAA, CGP, FDA, NIH, ClinicalTrials.gov, and other applicable entities Audience: Graduate 2. Apply and implement best practices for human subjects’ protection Audience: Graduate 3. Apply team science through working with multidisciplinary and interprofessional team Audience: Graduate 4. Analyze requirements in conduct of a clinical trial or health services research study and implement the use of a protocol to standardize procedures Audience: Graduate 5. Evaluate and select data collection processes and implement quality control and assurance processes Audience: Graduate 6. Create a protocol and consent/assent processes and documents for a clinical trial or health services research study, as well as supportive components Audience: Graduate
Sources
- Course catalogue ↗2026-2027