Researchers

Not sure where to start?

Contact clinicalresearch@mfa.gwu.edu

 

New Trial Startup

Please complete and submit our new study Intake Form

In response to GW's strategic initiative to enhance the research experience and feedback gathered during the faculty-led research ecosystem review, the Office of the Vice Provost for Research (OVPR) spearheaded the implementation of myResearch, an enhanced electronic research administration (eRA) tool. This tool is an integrated online system for proposal development and sponsored award management. 

Requirements for myResearch Submission:

  • FCOI (must be completed before submission)
  • Copy of FOA/Sponsor Guidelines (as applicable)
  • Statement of Work/Abstract
  • Budget
  • Budget Justification
  • Subrecipient Package (as applicable)
  • Cost Share Form (if applicable)
  • Multi-School Routing Form (if applicable)
  • Sponsor Package (as applicable)
  • *For proposal/award combos, a copy of draft grant or contract award

 

OVPR General Proposal Checklist for documents required in myResearch

POD3 Team:  

If you are planning to submit a grant for contact proposal to a federal, foundation, association or other non-profit sponsor, a dedicated team of pre-award specialists housed in GW's POD3 Team will facilitate your proposal routing and submission through the myResearch portal. Please submit the Notice of Intent Form to inform POD3 of the intended submission here.

A staff member from POD3 will contact you and be assigned to serve as point of contact to facilitate the proposal submission process. 

Please submit FINAL documents on time to POD3 so they can review your final documents prior to the routing process, which is five (5) business days before the sponsor deadline.

Please note all ancillary reviews should be approved in MyResearch and all files should be final at the time of routing. No changes to the budget once the routing has started.

Please see the deadline submission chart below:

Action / due date /

Set up Date

PI acknowledgement/ additional info

All final docs are due to SRA POD3

8 business day prior to the due date

 Email reminder will be sent by SRA if docs are not received

Routing start day (mandatory)

5 business days

The routing should be completed by the end of the day

Final reviews and comments addressing period

2-3 business days prior to the due date

PI and SRA work together to address the comments from OSP

Submitting to the Sponsor 2PM on the due day or earlier

Due date

By 2 PM all proposals must be submitted

The Clinical Trials Office of the GW Cancer Center is designed to develop clinical trials in cancer therapies. This office posts protocol templates and hosts a protocol review committee, https://cancercenter.gwu.edu/research/clinical-trials-office. Contact Richard Lush for instructions about start up.

 

 

With the upcoming Holiday season please note that the POD 3 team will not be able to respond to your inquiries/requests during:

·       Winter Break: Monday, December 26, 2022 - January 2, 2023

POD 3 will respond to your email and reconvene their normal schedule on January 3, 2023.

Additional Clinical Trial Support

Please see below for information on additional support available. 

       

      Coordinator Help for a Study

      A clinical research coordinator (CRC) plays an integral role to support, facilitate, and organize daily clinical trial activities, under supervision by a Principal Investigator. Clinical research coordinators also work in conjunction with the department, sponsor, and institution to guide them through compliance, finances, and personnel issues to manage the day-to-day clinical operations.

      The OCR will work with researchers to identify qualified coordinators. Contact Radwa Aly at clinicalresearch@mfa.gwu.edu

      Biostatistics Support

       

      The Biostatistics and Epidemiology Consulting Service (BECS): provides biostatistical and epidemiologic support to improve the quality of health-related research conducted at the George Washington University and by affiliated research groups.

      Biomedical Informatics Center: The Biomedical Informatics Center has access to the Cerner Health Facts database and uses statistical and machine learning methods for the development of the desired dynamic risk assessment.

      SMHS and University Research Core Facilities

       

      Posting a Study to gwdocs.com

      To add, edit, or remove a IRB-approved study to the GW MFA website, please complete our Clinical Trials Change Request form.

      Students in Clinical Research

      Medical student research, contact David Leitenberg: https://smhs.gwu.edu/research

      IRB amendments to add medical students: https://smhs.gwu.edu/sites/default/files/IRBAmendments-Nov2020.pdf

      Mentored Career Development Programs. KL2 / CTSI: https://smhs.gwu.edu/research/research-smhs/mentored-research-careers-and-nih-k-programs

       

      Research Pharmacy

      Engage the Investigational Drug Service to reestablish guidelines for the storage and dispensing of investigational medicinal products. The OCR establishes the process to involve the IDS early at study feasibility for storing and dispensing sponsor supplied drugs.  Ids@mfa.gwu.edu

      Location

      The Research Pharmacy is a licensed pharmacy that dispenses medications used in inpatient and ambulatory clinical trials performed by investigators at The George Washington University.

      Investigational Drug Service at The George Washington University
      George Washington Medical Faculty Associates (GW MFA)
      2150 Pennsylvania Ave NW, Suite 6A-404

      Hours: Monday through Friday, 7:30 AM to 4:00 PM

      Phone: 202-741-3624

      Fax: 202-741-3621

      Email: ids@mfa.gwu.edu (preferred method of contact)

      Overview of Services Provided

      In addition to drug preparation and dispensing for outpatient and inpatient areas, the IDS team can provide an array of services including:

      Comprehensive clinical review of all medication orders by a Clinical Pharmacist

      • Monitoring parameters
      • Dose adjustments and dose calculations
      • Drug interaction checking

      Provision of drug information to patients and healthcare team Assistance with clinical trial development

      • Assist with protocol development (for investigator-initiated studies)
      • Protocol review for feasibility
      • Development of a pharmacy budget and invoice
      • Review of EPIC/Beacon order sets
      • Development of a randomization tool
      • Development of a matching placebo

      Study drug accountability Drug and supply procurement, as needed Participation in Initial, Follow-Up and Close-Out sponsor visits Maintenance of blinding for blinded studies Record keeping and retention Quality assurance monitoring.