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New Trial Startup
Need Privacy Officer Approval?
Please send an email to firstname.lastname@example.org with the following documents attached:
- IRB Outcome letter
- HIPAA waiver reviewed by the IRB
- Protocol or application
- List of relevant data points
Turn-around is approximately one week.
If you have additional questions, please email the OCR at: email@example.com.
Additional Clinical Trial Support
- 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 firstname.lastname@example.org
- Posting a Study to gwdocs.com
REDCap is a HIPAA compliant, IRB- and GWU Compliance Office approved method of collecting and storing research data, including surveys and case report forms in an online database. There are other features to using REDCap, including audit trails, e-consent tools, the ability to directly export data to statistical packages, and integrating data with other applications such as tableau.
Online training is currently not mandatory but available if needed to new users. All new users must complete the account approval form, If you need help with REDCap, you can email their support team at REDCap@gwu.edu or reach out to our REDCap administrator, Bryan Gerald at email@example.com.
- allow users to initiate and submit research protocols online;
- automate the workflow for review of protocols by staff and boards such as the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), and the Institutional Biosafety Committee (IBC); and
- provide collaborative tools for studies with multiple sites.
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
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
Email: firstname.lastname@example.org (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.
Study Participant Payment Procedure
Clinical trials frequently issue participant incentive payments and reimbursements. If you would like to request gift cards for your participants, please review the information about the Forte participant payment system.
For questions about the Forte system, please contact Shelley Shearer at email@example.com or 571-553-4261.
Research Guidance Documents
All of the institution-wide Research SOPs can be found on the Compliance 360 Policy Module.
- Other Guidance Documents