Intensive Program in Clinical Research Methods | NYU Langone Health

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Clinical & Translational Science Institute Certificate & Training Programs Intensive Program in Clinical Research Methods

Intensive Program in Clinical Research Methods

The Intensive Training in Research Statistics, Ethics, and Protocol Informatics and Design (INTREPID) program at NYU Langone’s Clinical and Translational Science Institute provides medical students and healthcare professionals with classroom-based, intensive coursework focused on foundational training in clinical research methodologies.

You must complete coursework in clinical research methods, biostatistics, medical bioinformatics with programming, and the ethical conduct of research during this nine-credit, three-and-a-half-week immersive summer program.

The program is open to NYU Langone–affiliated healthcare professionals, including dental, medical, and nursing school postdoctoral trainees and faculty, as well as individuals from other institutions affiliated with the Clinical and Translational Science Awards of the National Institutes of Health (NIH). Full-time attendance is mandatory. You must have 100 percent protected time for the 3.5-week period in July to participate in the INTREPID program.

INTREPID Courses

Each of the three for-credit course meets for a total of 35 hours of classroom instruction, and the Ethical Conduct of Research course (not for credit) meets for 10 hours. You are required to attend all classroom sessions and complete all assigned homework and self-study materials.

Introduction to Clinical Research Methods

Beginning with the formulation of a research question, this course addresses the planning and performance of clinical research. It reviews specific study designs and highlights the elements of protocol development, with an emphasis on methodologies and regulatory requirements pertaining to human subject research. Topics include selection of relevant study cohorts and controls, study interventions, trial registration, randomization, confounders, bias and blinding, data collection, safety and monitoring, endpoints, and presentation and communication of results.

Course Director: Claudia S. Plottel, MD
Credits: 3

Introductory Biostatistics

Introductory Biostatistics provides instruction and training in statistical methods relevant to clinical and translational research. Topics center on fundamental elements of study designs, such as randomization, sample selection and size, and power analysis.

The course also covers specific biostatistics methods in depth, including data summarization; data analysis and inference, including numerical summarization and graphical display; evaluation of medical diagnostic tests; estimation with confidence and hypothesis testing; correlation and regression; and survival analyses. Hands-on instruction in using a statistical software package is also provided.

Course Director: Yongzhao Shao, PhD
Credits: 3

Introduction to Medical Bioinformatics and Computing

Introduction to Medical Bioinformatics and Computing introduces students to informatics programming, selected topics in medical informatics, and case studies involving informatics analysis. Topics include data management, clinical decision support, health information exchange, natural language processing, biomedical vocabularies, meaningful use, and clinical information systems.

Course Director: Vincent Major, ME, MS
Credits: 3

Ethical Conduct of Research

Ethical Conduct of Research focuses on ethical considerations regarding human and animal subjects and maintaining scientific integrity in data management, analysis, authorship, and publication. Topics include peer review, scientific fraud, conflict of interest, mentoring, intellectual property, collaborations (including industry), and the role of scientists in society.

This course is required for all individuals who need to meet their NIH-mandated ethics training at their current career level. Those who have already met their NIH requirement and who can provide appropriate documentation may request to opt out, with permission from INTREPID program directors.

Course Director: Carolyn R. Chapman, PhD
Email: carolyn.chapman@nyulangone.org
Credits: None

How to Apply to INTREPID

Applicants must complete the INTREPID application form. Required materials include a CV; a personal statement that addresses reasons for applying and details career plans beyond training; two letters of reference; a recent photograph; and information about the party responsible for tuition payments.

To learn more about the INTREPID program, contact program director Claudia S. Plottel, MD, at claudia.plottel@nyulangone.org, program manager Claudia Galeano at claudia.galeano@nyulangone.org, or Daniel Cobos, project associate, at daniel.cobos@nyulangone.org.