We're still actively developing this site. If you encounter any issues, please report them! - Report an issue

INTRODUCTION TO CLINICAL AND HEALTHCARE RESEARCH II

BMI 544
Course Description

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.

Prerequisties
Satisfies

This course does not satisfy any prerequisites.

Credits

Not Reported

Offered

Not Reported

Grade Point Average
3.88

12.65% from Historical

Completion Rate
100%

5.26% from Historical

A Rate
75%

54.64% from Historical

Class Size
8

-32% from Historical

Instructors (2025 Fall)

Sorted by ratings from Rate My Professors

Similar Courses

FOUNDATIONS OF DATA-DRIVEN HEALTHCARE

BMI 573

Familiarize students with basic informatics principles and techniques to support clinical research and quality improvement studies from a perspective of data-driven approaches. Content includes information systems for study design; regulatory compliance; use of electronic health records data for research; data collection and acquisition; data security, storage, transfer, processing and analysis.

INTRODUCTION TO CLINICAL TRIALS I

BMI/STAT 542

Intended for biomedical researchers interested in the design and analysis of clinical trials. Topics include definition of hypotheses, measures of effectiveness, sample size, randomization, data collection and monitoring, and issues in statistical analysis.

FUNDAMENTALS OF INFORMATICS IN CLINICAL RESEARCH

BMI 901

Become familiar with basic informatics principles and techniques to support clinical research. Content includes information systems for protocol design; regulatory compliance; approaches for patient recruitment; efficient protocol management; data collection and acquisition; data security, storage, transfer, processing and analysis.

CLINICAL RESEARCH INFORMATICS

BMI 773

Course will familiarize students with basic informatics principles and techniques to support clinical research. Content includes information systems for protocol design; regulatory compliance; approaches for patient recruitment; efficient protocol management; data collection and acquisition; data security, storage, transfer, processing and analysis.

CLINICAL TRIAL DESIGN, IMPLEMENTATION, AND ANALYSIS

BMI/STAT 643

Gain an understanding of fundamental elements of clinical trials (such as objectives, endpoints, surrogate endpoints, and statistical decisions) and statistical design considerations (such as randomization and blinding). Designs of clinical trials for Phase I, II, and III studies including single-arm, two-arm, and drug combination trials. Introduction to adaptive designs for precision medicine and master protocol designs such as umbrella trials and basket trials.