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INTRODUCTION TO CLINICAL AND HEALTHCARE RESEARCH II

BMI 544
과목 설명

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.

선수과목
충족 요건

This course does not satisfy any prerequisites.

학점

미보고

개설 시기

미보고

평점
3.88

12.65% 과거 데이터 대비

수료율
100%

5.26% 과거 데이터 대비

A 비율
75%

54.64% 과거 데이터 대비

학급 규모
8

-32% 과거 데이터 대비

Cumulative Grade Distribution

강사 (2026 Summr)

다음 사이트의 평점순으로 정렬 Rate My Professors

유사 과목

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.

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.

STATISTICAL METHODS FOR CLINICAL TRIALS

BMI/STAT 641

Statistical issues in the design of clinical trials, basic survival analysis, data collection and sequential monitoring.

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.

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.