CLINICAL RESEARCH NAVIGATOR

A quarterly newsletter brought to you by the GW Office of Clinical Research

As we welcome the fall season—a time of transformation and renewal—we are excited to share some of the significant strides the Office of Clinical Research has made in modernizing our workflows and operations. Over the past few months, we’ve implemented new systems, streamlined key processes, and adopted innovative technologies that enhance efficiency, collaboration, and data quality across all phases of our research enterprise.

These changes reflect our ongoing commitment to advancing research excellence, improving participant experiences, and empowering our teams with tools that support smarter, more agile ways of working. While change can bring challenges, it also opens new opportunities—and your dedication and adaptability have been instrumental in making this evolution a success.

In this issue, we’ll highlight recent achievements, introduce new tools and initiatives, and share updates from across our research community. Together, we’re shaping a stronger, more modern foundation for the future of clinical research across our academic medical enterprise.

Research Reporting Requests - Research Reporting Request Submissions - Submission Gallery

This workflow applies to any data report requests needed for research projects that include:

This process offers several key improvements to make your work more efficient:

Florence’s eBinders and eConsent solutions are streamlining research operations and compliance at GW.

eBinders is a dynamic digital regulatory binder that centralizes, organizes, and secures all study documents, giving teams instant access to the files they need anytime, anywhere. The eBinders platform includes enhanced eDOA and eLog features, simplifying documentation and tracking of study delegation and essential regulatory logs in real time. Built-in e-signature functionality ensures that approvals and document sign-offs are completed securely and efficiently—no more paper bottlenecks. Together, these tools support faster study start-up, improved audit readiness, and seamless collaboration across research teams.

The eConsent feature allows participants to review and sign consent forms remotely, improving accessibility and participant engagement while maintaining regulatory compliance. With real-time tracking and version control, research teams can ensure every consent is properly documented and up to date, reducing administrative burden and improving participant trust.

For more information on training and access, visit our website or email Alice Pascalev apascalev@mfa.gwu.edu.

Congratulations to Radwa Aly, PhD, Chief/Executive Director, Clinical Research Administration & Operations, on her election to serve as President of the Board of Directors for the International Network for the Science of Team Science (INSciTS) for the 2025–26 term.

We are pleased to announce a new addition to the Office of Clinical Research website. The Investigational Drug Service page gives a brief overview of services offered by the IDS pharmacy. This page comes in addition to the IDS Pharmacy Policies page, which provides detailed information on proper use of the IDS Pharmacy.

Beginning in May 2025, new Federal training and disclosure requirements were implemented by several agencies. These apply to Research Security, CITI Training, and Disclosure of Other Support.  

These requirements apply to Key Persons. Key Persons include PIs, mPIs, Co-Is, and others whose role is critical to the project or have been identified as a Key Person by the PI in the application. In short, a Key Person is someone whose expertise or contributions cannot be easily replaced. Typically, Coordinators (Research or Clinical), Fiscal Admins, Post-docs, etc. are not Key Persons.

Non-compliance with these changes may result in submission delays and award acceptance. Please reach out to Research Security if you need additional guidance on whether this requirement applies to you (rsec@gwu.edu). 

The FDA announced the availability of, the International Council for Harmonization (ICH) released ICH E6 (R3), the updated global standard for Good Clinical Practice (GCP) on September 9, 2025

These updates reflect today’s research environment — integrating technology, decentralization, and a stronger focus on participants and data integrity.

Below are the key takeaways for our research community:

ICH E6 (R3) supports high-quality, ethical, and participant-focused research while allowing flexibility for innovation.

Our shared goal remains the same — ensuring research excellence, participant safety, and trustworthy data.

Contact the Office of Clinical Research / Research Compliance at clinicalresearch@mfa.gwu.edu.

For the most accurate and up-to-date information, please be sure to check out the OCR website. As we continue to grow, we will continue to add more information and resources. If you have any feedback on the OCR website, please email clinicalresearch@mfa.gwu.edu.