Conducting the Study

Now that you’ve successfully secured funding for your project, it’s time to begin actively conducting your research. Project success is dependent on good management that spans the entirety of your research study. The resources here will help you organize the various processes included in managing participant recruitment, data collection, regulatory activities, and program evaluation. 

Project Management

• Project Management for Scientists
  • This AAAS article outlines the key components of project management and premises that lead to project success.
• Planning and Managing Scientific Research: A guide for the beginning researcher
  • This book provides a guide to successful practice in research, drawing on experience of major research projects and research management.
• Project Management Toolkit
  • Wiley’s Project Management Toolkit for Scientists provides tools and exercises to help you develop project management skills that will advance your research.
• Organizational Race Equity Toolkit
  • Within this Organizational Race Equity Toolkit, navigate to pages 67-69 to view the Iceberg Model. The Iceberg Model is useful to unpack the underlying causes that lead to an acute event or issue.

Participant Recruitment

• Patient Recruitment in Clinical Trials: Steps to Develop a Successful Enrollment Strategy
  • This book will guide you through developing and launching your recruitment strategy.
• PowerTrials Prescreening Tool 
  • PowerTrials Prescreening is a Cerner-developed, HIPAA compliant prescreening application that enables a Researcher to search the electronic health record (EHR) for potential research participants using pre-established inclusion and/or exclusion criteria.
• Health Equity-based Recommendations to Promote Patient Safety
  • This editorial summarizes the practical lessons for advancing health equity sustainably, with the hope of accelerating equity in patient safety.
• Achieving Diversity and Inclusion in Clinical Trials Recruitment (Checklist) 
  • Download the toolkit and navigate to page 63 to access this checklist.
• Roadblocks to Minority Participation in Clinical Research
  • This article examines the numerous challenges to securing diversity in clinical trials, and the consequences of primarily white patient populations.

Data Collection & Management

• REDCap 101 Online Training Registration
  • REDCap (Research Electronic Data Capture) is a secure web application for building and managing online surveys and databases.
  • GW affiliates may request a REDCap account on the GW REDCap website.
  • CNH affiliates may request a REDCap account on the CTSI-CN REDCap website. 
• Electronic Health Record
  • This guide outlines EHR Meaningful Use, Interoperability, Standards and Vocabularies, and Clinical Decision Support.
• Public Health Datasets 
  • This guide provides resources for accessing national and international public health datasets.
• Data Management: Rigor and Reproducibility
  • This guide is designed to assist early career researchers with developing a data management plan.
• OpenClinica
  • OpenClinica is a commercial open source clinical trial software serving for the purpose of clinical data management (CDM) and electronic data capture (EDC).
  • GW and CNH investigators may request an informatics consultation through the SPARC portal for data management strategies using OpenClinica. 
• A Toolkit for Centering Racial Equity Throughout Data Integration
  • This toolkit seeks to encourage shifts of awareness and practice, by centering racial equity and community voice within the context of data integration and use.
• Improving Health Equity Through Data Collection
  • This guide for hospital leaders outlines the need for hospitals and health systems to bridge the gap between collecting meaningful patient data and reviewing the data to identify inequities in health care provision and utilization, and to implement simple yet effective interventions to improve care for patients.
• Framing Data to Advance Equity
  • These tips were developed for professionals who work with population data, to spark ideas about how to frame data to tell the full story.

 

Regulatory Processes

• Regulatory Science Boot Camps
  • The D.K. Kim International Center for Regulatory Science hosts symposia on current regulatory science topics regarding clinical trials.
• Regulatory Binder Checklist 
  • Several essential documents must be organized and retained for clinical studies. These organized documents are referred to as the Regulatory Binder (or Investigator Binder), which is retained at the Investigator’s clinical site. Scroll through this toolbox to access the checklist and related documents. 
• Antiracism Action Plan
  • Navigate to page 8 of this antiracism action plan to access information about Implementation Targets, Measurement, and Reporting.

Access Health Equity Toolkit

• Health Equity Series 
  • This course is designed for anyone in the health professions- students, staff, administrators, faculty, researchers, and clinicians. Upon conclusion of this program, participants should be able to:
    • Recognize the importance of teaching about the social, environmental, and structural factors that threaten health equity
    • Create inclusive climates, policies, and practices to address the challenges of health equity
    • Seek out equitable and sustainable institutional and community partnerships to advance health equity
• Community Health Equity (video)
  • This 1 hour 30 minute webinar will introduce participants to health equity, culturally competent approaches, and how to think collaboratively about ways to effectively engage diverse populations/communities in their efforts.

Designing a Program Evaluation

• Designing a Program Evaluation (Checklist)
  • The purpose of this checklist is to provide support for program evaluators who design, develop, implement, and disseminate evaluations. This checklist is designed to assist the evaluator to include all individuals in the evaluation process; people of all ages and all abilities.

Resources

• Research Match Tool
  • Using ResearchMatch's Feasibility Analysis tool, researchers can assess the quantity and accessibility of volunteers that match specific inclusion/exclusion criteria
• Data Management Tool 
  • Create data management plans that meet institutional and funder requirements.
• Racial Equity Toolkit
  • The REJI Organizational Race Equity Toolkit aims to help its partner organizations apply a racial equity lens to their operations, programming, workplace culture, governance, partnerships, and advocacy. The Toolkit guides you though several aspects of what it means to undertake race equity work within an organization.

Institutional Contacts

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• GWU Academic Commons
  • Consultations for Writing, Research, and Statistical/GIS/Coding/Programming Consultations.
• BECS Quick Clinic
  • 1 Hour statistical consultations for GW-based faculty, medical residents and fellows, and staff working with GW faculty.  
• GW Research Technology Services 
  • For computationally-intensive research computing and other research-related technology services.
• Research Launcher 
  • The CTSI-CN Research Launcher is a resource designed to help anyone involved in clinical and translational research find the support they need to advance their research. Our Navigators will guide you through the Research Launcher process and connect you with the expertise, resources, tools, and services needed to accelerate your research.