Not sure where to start?
Contact clinicalresearch@mfa.gwu.edu
New Trial Startup
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.
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 |
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.
- 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
For information on CTSI-CN support for KL2 formal research training please review the Mentored Research Careers and NIH K Programs page.
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-404Hours: 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.