Clinical Trials Office

The Clinical Trials Office supports the design, launch, and conduct of cancer clinical trials across the GW Cancer Center. By providing centralized expertise and coordination, the office helps investigators bring innovative studies to patients efficiently, safely, and in compliance with institutional and federal requirements.

Our Role

The Clinical Trials Office serves as a shared resource for cancer investigators, clinical teams, and research staff. The office works closely with faculty and partners to streamline trial operations, support high‑quality research, and promote consistency across studies. This centralized approach strengthens the Cancer Center’s clinical research infrastructure and advances access to investigational therapies.

Services and Support

The Clinical Trials Office provides comprehensive support throughout the clinical trial lifecycle, including:

• Study development and feasibility assessment
• Regulatory submissions and compliance oversight
• Trial initiation and site coordination
• Participant accrual support
• Data management and study monitoring

These services help ensure that clinical trials are conducted with scientific rigor, operational efficiency, and patient safety as top priorities.

Supporting Investigators and Study Teams

Investigators and study teams partner with the Clinical Trials Office to navigate complex regulatory and operational requirements. The office provides guidance on protocols, timelines, and reporting, allowing researchers to focus on study design, implementation, and scientific outcomes.

Collaboration and Partnerships

The Clinical Trials Office works in close collaboration with clinical departments, institutional offices, and external partners. Through coordination with Children’s National Hospital and the Washington DC VA Medical Center, the office supports trials that serve pediatric and veteran populations and strengthens multi‑site and multidisciplinary research efforts.

Advancing Clinical Research

By supporting well‑designed and efficiently managed clinical trials, the Clinical Trials Office plays a critical role in advancing cancer research at GW. The office helps translate scientific discoveries into clinical studies that contribute to improved treatment options, evidence‑based care, and meaningful outcomes for patients.

What would you like to do?

Write a protocol

GW Cancer Center Investigators may use the MS Word Protocol Templates provided below or use the Protocol Builder application.  The GWCC Phase 2 Study and the Retrospective Chart Review & Data templates are loaded within the Protocol Builder application.  The George Washington University provides free access to investigators for Protocol Builder that speeds the development of research protocols that comply with IRB and regulatory standards. 

Access Protocol Builder

GW Cancer Center Phase 2 Protocol Template

GW Cancer Center Retrospective & Data Protocol Template

GW Cancer Center Observational Study Protocol Template

Submit a protocol for review

What do I need to submit?

• Completed Protocol Review and Monitoring Committee (PRMC) Submission Form along with the protocol
   
• If your study involves an investigational drug, please submit your Investigator's Brochure or other details about the drug(s) involved

When do I need to submit the form?

The Protocol Review and Monitoring Committee (PRMC) meets on the first Thursday of each month. To be considered for review, the completed form, protocol and Investigator's Brochure (if relevant) must be submitted at least two weeks prior to the meeting date.

Protocol Review and Monitoring Committee (PRMC)

GWCC 2026 PRMC Meeting Schedule

PRMC Meeting Date (1st Monday of each Month)	Deadline for Protocol Submission*
01/05/2026	12/22/2025
02/02/2026	01/19/2026
03/02/2026	02/16/2026
04/06/2026	03/23/2026
05/04/2026	04/20/2026
06/01/2026	05/18/2026
07/06/2026	06/22/2026
08/03/2026	07/20/2026
09/14/2026	08/31/2026
10/05/2026	09/21/2026
11/02/2026	10/19/2026
12/07/2026	11/23/2026

Meeting Schedule

The Protocol Review and Monitoring Committee (PRMC) meets monthly; if there is pressing demand, additional meetings are called. Ad hoc committee meetings may be conducted virtually, via email, or in person as needed to ensure timely review or re-review of protocols. The committee will strive to provide flexibility to accommodate time-sensitive research deadlines. 

Timelines for Submission 

• Administrative, Exempt, and Expedited reviews: initial review and amendments are accepted on a rolling basis and will be assigned for review upon receipt of all required materials by the PRMC coordinator. 
   
• Full Committee Review: all required materials must be received by the PRMC coordinator at least 10 business days (~2 weeks) in advance of the next scheduled PRMC meeting. This is to ensure adequate time for the committee to review. *All materials must be submitted by 5:00 PM on the deadline date.

Get coordinator help for a study

Coordinators can assist with study needs, depending on availability. To learn more or request assistance, email rmlush3 [at] gwu [dot] edu (Dr. Richard Lush).

Access OnCore and/or EDC and find training materials

Visit the Accounts and Support page to request a user account, log in and access training materials.

Access REDCap

Visit the Clinical and Translational Science Institute at Children's National (CTSI-CN) website to learn more and access REDCap.

Find additional trainings

A variety of trainings and resources are available through the CTSI-CN website.

Navigation Assistance

Need help planning or conducting a clinical study? Our staff can evaluate your needs, guide you through the various stages of carrying out a clinical study and connect you with many resources available across the George Washington University (GW) and the GW Cancer Center.