Observational Research Protocols: An Introduction

Essentials of observational research protocol design and development.

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About this Course

Observational studies are important and exceedingly useful in the biomedical and social sciences, as well as other fields such as education. This course introduces observational research and explores three types of study designs commonly used: cross-sectional, case-control, and cohort (both prospective and retrospective). Learners will explore the strengths and weaknesses of each and what research questions they best address. The course culminates with an overview of how to develop and effectively write an observational research protocol.

This course was written by Ilene Wilets, PhD – Icahn School of Medicine at Mount Sinai and peer-reviewed by experts.

Language Availability: English

Suggested Audiences: HRPP Professionals, IRB Members and Administrators, Research Staff, Researchers, Undergraduate and Graduate Students

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person

Demo Instructions

Course Content

Introduction to Observational Research

This first module provides an overview and key characteristics of observational research, introducing these three primary study designs: cross-sectional, case-control, and cohort. Learners will explore the various approaches to sampling and measurement within each study design. The module concludes with a discussion of the challenges and types of bias associated with each design and ethical considerations related to the conduct of specific types of observational research.

Recommended Use: Required
ID (Language): 20340 (English)
Author(s): Ilene Wilets, PhD - Icahn School of Medicine at Mount Sinai

Designing a Cross-Sectional Study

This module details the design and utility of cross-sectional studies, highlighting the various strengths, weaknesses, and bias inherent in this type of observational research. It also indicates how a cross-sectional study design measures exposures and outcomes and identifies the analytic approach for cross-sectional study data.

Recommended Use: Required
ID (Language): 20341 (English)
Author(s): Ilene Wilets, PhD - Icahn School of Medicine at Mount Sinai

Designing a Case-Control Study

Case-control study design involves backward data gathering, which can be extremely useful in the investigation of disease etiology and the rapid restoration of public health. In this module, we will learn about the unique design of case-control studies, along with the strengths, weaknesses, and bias characteristic of this mode of observational research. The module discusses how to identify and establish case and control groups to foster comparability, including topics such as appropriate matching, importance of odds ratio statistic, and identification of potential confounding variables.

Recommended Use: Required
ID (Language): 20343 (English)
Author(s): Ilene Wilets, PhD - Icahn School of Medicine at Mount Sinai

Designing an Observational Cohort Study

This module addresses the design and conduct of observational cohort studies. It describes and distinguishes between prospective and retrospective designs. The module explores the distinct advantages, disadvantages, and common types of bias relative to cohort study design. We consider sample size considerations, measuring exposure and outcome, and calculating relative and attributable risk and hazard ratio. In addition, we will consider the ethical challenges that can arise during the conduct of these studies.

Recommended Use: Required
ID (Language): 20342 (English)
Author(s): Ilene Wilets, PhD - Icahn School of Medicine at Mount Sinai

Putting Your Protocol Together

This final course module will address how researchers can conceptualize and write an effective observational research protocol. It presents a hypothetical observational research study and the considerations for different study designs, leading to the most appropriate choice of design for the study aims. The module walks the learner through developing an observational research protocol from start to finish. It also covers important human subject safety considerations including recruitment, informed consent, study risk and benefit, and data confidentiality and security.

Recommended Use: Required
ID (Language): 20344 (English)
Author(s): Ilene Wilets, PhD - Icahn School of Medicine at Mount Sinai


Who should take this Observational Research Protocols course?

This course is intended for researchers, research staff, IRB members, and HRPP professionals as well as undergraduate and graduate students.

How long does this course take to complete?

This course consists of five modules that contain detailed content, images, supplemental materials (such as, case studies), and a quiz. Learners may complete the modules at their own pace. Each module varies in length, and learners may require different amounts of time to complete the module based on their familiarity and knowledge of the topic. As a rule of thumb, modules can take about 20 to 25 minutes to complete, which means this course may take learners around three hours to complete.

How often should I take this course?

This course is meant to be completed once. Although learners can revisit modules and topics once they complete the course for refresher training.

What are the standard recommendations for learner groups?

CITI Program allows organizations to customize their learner groups, which means they can choose the content modules their learners need to complete. We will work with your CITI Program designated admin to determine the learner groups that best fit your organizational needs.

The typical recommendation for this course is to designate all five of the modules as Required.

Is this course eligible for continuing medical education credits?

This course is not eligible at this time.

What are the advantages CITI Program’s Observational Research Protocols: An Introduction course?

This course provides specific, peer-reviewed training on observational research written by an expert. It goes beyond a general research design course by exploring study designs in-depth and with examples. It also provides a module to walk learners through how to write their own protocols.

Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for observational research training.

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