Medical Residents and Fellows: Basic Principles of Research

This module introduces various aspects of research methodology and evidence-based practice. It starts by defining research and emphasizing its role in advancing patient care. The module discusses the development of research questions using the PI(E)COT format, emphasizing specificity and relevance. Additionally, it explores the hierarchy of evidence and the FINER criteria for successful research projects through a case study on the impact of urine drug screening in emergency department management.

Recommended Use: Required
ID (Language): 21214 (English)
Author(s): Bashar Shihabuddin, MD, MS - BJE Consultants; Jessica Fritter, MACPR, ACRP-CP - BJE Consultants; Courtney Shihabuddin, DNP, APRN-CNP, AGPCNP-BC - BJE Consultants

This module of the course describes basic research study designs including cohort, case-control, randomized, and cross-over designs. It identifies the types of research designs used in clinical research for primary and secondary sources of data. Presenters discuss considerations for validity of different study designs and teach learners about the methods used to reduce bias. The module ends with an example case to apply a study design to a research question.

Recommended Use: Required
ID (Language): 21215 (English)
Author(s): Bashar Shihabuddin, MD, MS - BJE Consultants; Jessica Fritter, MACPR, ACRP-CP - BJE Consultants

In this module, presenters discuss the basic methodology of clinical research. They describe the statistical methods involved in research including basic biostatistics, descriptive statistics, graphical display of data, simple hypothesis testing, categorical data analysis, sample-size estimation, and introductory regression analysis. The module concludes with considerations for how research methodology principles apply to the protocol (such as subject population size and enrollment criteria).

Recommended Use: Required
ID (Language): 21216 (English)
Author(s): Bashar Shihabuddin, MD, MS - BJE Consultants; Jessica Fritter, MACPR, ACRP-CP - BJE Consultants

This module guides learners in how to critically appraise the research literature. It identifies key components of a critical appraisal, reviews the steps for an advanced literature search, and provides strategies to synthesize the literature to appraise a biomedical research article critically.

Recommended Use: Required
ID (Language): 21217 (English)
Author(s): Courtney Shihabuddin, DNP, APRN-CNP, AGPCNP-BC - BJE Consultants

This module reviews the main sections that comprise a research protocol. Then, further explanation is given to data management and data collection, as well as data storing and sharing. The module reviews subject population design considerations, including sample size and power, issues in randomization, measures, and eligibility criteria. It concludes with a discussion on outcome measures and how they relate to the research question and aims.

Recommended Use: Required
ID (Language): 21218 (English)
Author(s): Bashar Shihabuddin, MD, MS - BJE Consultants; Jessica Fritter, MACPR, ACRP-CP - BJE Consultants

This module discusses the major milestones in the history of human subjects research that have affected current research regulations and practice. It identifies the Belmont Report’s ethical principles for research and how they apply to research conduct and review. The presenter describes when an Institutional Review Board (IRB) review is required for research activities and explores IRBs regulatory review criteria (per the Common Rule). Further, the module reviews safety monitoring in clinical research.

Note: This module is not designed to replace Human Subjects Research training.

Recommended Use: Supplemental
ID (Language): 21219 (English)
Author(s): Ilene Wilets, PhD - Icahn School of Medicine at Mount Sinai

This modules is for learners who want to understand the manuscript preparation process. It discusses how to select a journal for publication of research findings, the peer review process, and dissemination strategies for research. Further, it considers responsible conduct of research and defines research misconduct issues.

Recommended Use: Supplemental
ID (Language): 21220 (English)
Author(s): Bashar Shihabuddin, MD, MS - BJE Consultants; Jessica Fritter, MACPR, ACRP-CP - BJE Consultants; Courtney Shihabuddin, DNP, APRN-CNP, AGPCNP-BC - BJE Consultants

This module explains how the U.S. Food & Drug Administration (FDA) regulates the approval of drugs and devices. It covers the role Good Clinical Practice (GCP) standards play in U.S. federal regulation of drug and device research. The presenter considers items that trigger the application of other agencies’ requirements to clinical trials and directs learners to where additional information on these requirements can be found. The module summarizes how researchers can ensure compliance with applicable regulations, standards, and policies.

Recommended Use: Supplemental
ID (Language): 21221 (English)
Author(s): Kris West, JD, MS - Council on Government Relations (COGR)