Study Design

Choosing the right methods and approach to best answer your research question is critical to the success of your project. There are many effective, proven study designs to choose from; so how do you make sure you’ve chosen the best design? 

The resources and consultation services listed here can take the mystery out of this essential step in the research process.

Understand Study Design Options

• Choose a Research Design
  • This Evaluation Toolkit will guide you through selecting the appropriate research for your study.
• Types of Studies
  • Provides study definitions, describes various levels of evidence, and recommends databases for filtered and unfiltered information.
• Explore Various Study Designs
  • Adaptive Designs
  • Hybrid Designs
  • Designs for Small Samples
  • Bayesian Designs
  • Basket Designs
  • Pragmatic Clinical Trials
  • Longitudinal Designs
• Study Design Tutorial
  • This tutorial is designed to give you an understanding of different types of clinical medical studies and how they relate to each other.
• Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
  • This Living Textbook reflects a collection of special considerations and best practices in the design, conduct, and reporting of pragmatic clinical trials.
• Applying an Antiracist Framework Toolkit
  • Provides a structured approach to equip new and existing faculty with the tools to engage learners in topics of health disparities, social justice, bias, and racism in the classroom and clinical environment

Determine Your Study Population

• TriNetX
  • TriNetX is a dynamic, data driven platform that leverages the i2b2 data warehouse and Cerner PowerChart (EHR). A researcher can easily generate a query to perform study feasibility and cohort discovery.
• How do I center People of Color in my study?
  • This article outlines five ways to recognize multiplicities of identities and create space for people of color.

Know Your Research Ethics

• Ethics in Research and Publishing 
  • This guide contains everything you need to know about the publishing lifecycle, copyright, self-archiving, and promoting your research.
• Research Ethics Webinar (GW Bioethics Interest Group)
  • Scroll to the bottom of the page to view the webinar series on Ethics & COVID-19.
• Community Advisory Boards (CAB) Regulating Ethics
  • This article explores the role of CABs in the informed consent process.
• Historical Trauma & Unresolved Grief: Implications for Clinical Research and Practice with American Indians & Alaska Natives
  • This article reviews the conceptual framework of historical trauma, and discusses historical trauma and implications for research, clinical, and community interventions.
• Ethics, Conduct, and Oversight of Multi-Regional Clinical Trials
  • The MRCT Center of Brigham and Women’s Hospital and Harvard houses various projects and toolkits to ensure that clinical trials are performed safely and ethically by rigorous methodology.
• Using Participatory Action Research to Prevent Further Marginalization
  • This case study provides insights into why participatory action research is intentionally selected to critique power imbalances between the researcher and the “researched.”
• Ethical Clinical Trials (Modules)
  • This Ethics Tool Kit was created to encourage protocol authors to address ethical issues in the design of studies and document their rationale in a section of the protocol

Resources

• ACT Network (SHRINE)
  • The ACT Network (SHRINE) helps researchers design and complete clinical studies, and is secure, HIPAA-compliant and IRB-approved.
• Methods to Community Discussion and Reflection
  • Planning guide for community discussion and reflection processes.
• Guide to Indigenizing Community Based Research
  • This report discusses community-based research within the thematic area of Indigenous research methodologies.
• Building Community Engagement
  • This Community Engagement Guide promotes effective engagement and customer service with all county communities.

Institutional Contacts

• Study Design Support: SparcRequest and SparcRequest Instructions 
  • The CTSI-CN currently uses the SPARC system for all BERD and PCI request for services. Once you create a login user ID and password you can submit a request. All requests receive four hours of free service and we use both the percent effort and hourly rate charge models. The link below provides more details on how to complete this process.