Clinical Trials Office

Welcome to the Clinical Trials Office

The objective of this office is to facilitate the process of moving clinical trials from initial proposal to successful completion in a regulatory-compliant fashion.This includes review and execution of confidentiality disclosure agreements, cost and feasibility analysis, budget development and contract execution. In addition, this office also provides financial oversight and invoicing for clinical trials.

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, please contact Dr. Richard Lush at rmlush3 [at] gwu [dot] edu (rmlush3[at]gwu[dot]edu).

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.