Clinical Research

Tutorial: From clinical data management to clinical data science: Time for a new educational model

May 12, 2023 by Stephen Sonstein

The following tutorial was recommended to the COAPCR members.

Ittenbach RF. From clinical data management to clinical data science: Time for a new educational model. Clinical and translational science. 2023. https://doi.org/10.1111/cts.13545

Abstract

The purpose of this article is to propose and provide a blueprint for a graduate-level curriculum in clinical data science, devoted to the measurement, acquisition, care, treatment, and inferencing of clinical research data. The curriculum presented here contains a series of five required core courses, five required research courses, and a list of potential electives. The coursework draws from but does not duplicate content from the foundational areas of biostatistics, clinical medicine, biomedical informatics, and regulatory affairs, and may be reproduced by any institution interested in and capable of offering such a program. This new curriculum in “clinical” data science will prepare students for work in academic, industry, and government research settings as well as offer a unifying knowledge base for the profession.

Article (PDF) 

Achieving Diversity, Inclusion, and Equity in Clinical Research

Mar 3, 2021 by Admin

The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MCRT Center) published in August 2020 and revised in January 2021 the “Achieving Diversity, Inclusion, and Equity in Clinical Research,” a comprehensive Guidance Document and Toolkit that aims to clarify the importance of, advance the goals of, and provide practical and actionable ways to improve diverse representation of participants in clinical research.

Website is interactive and has access to the downloadable guidance document, toolkit, webinars, and book ordering information. 

Moving from Compliance to Competency

Oct 1, 2014 by JoAnn Pfeiffer

  clinical-research-competencies.pdf 

Presentation - Harmonized Core Competencies for the Clinical Research Professional

Oct 1, 2014 by JoAnn Pfeiffer

  powerpoint-competencies.pdf