Clinical Trials Office

Protocol Review and Monitoring System
The Protocol Review and Monitoring System (PRMS) oversees and provides independent peer review of the scientific merit, priority, and progress of all cancer studies involving human subjects conducted across Georgetown Lombardi. PRMS functions are accomplished by rigorous review in a two-stage process conducted by:

• Disease Groups
• Scientific Review Committee

The Investigator Initiated Trials (IIT) Office supports investigators throughout the IIT lifecycle, including providing:

• Assistance with budget development
• Protocol templates and medical writers for protocol development, reporting, and publication
• Facilitation of biostatistical support for protocol development and reporting
• Regulatory document submission, maintenance, reporting, and close-out, including submission to federal regulatory agencies and sponsors
• Support for trial conduct including multi-site coordination
• Quality control assessments and monitoring

Clinical Research Leadership Committee
The CRLC includes leadership from Scientific Review Committee, Data Safety Monitoring Committee, CTO administrative directors and other key clinical research stakeholders, and monitors accruals with attention to underrepresented minorities, study performance metrics, and compliance.

Data Safety Monitoring Committee
The Data and Safety Monitoring Committee (DSMC) is an independent group of experts housed within Georgetown University. The members of the DSMC are tasked with the responsibility of prospective monitoring of all clinical trials assigned to the DSMC, to ensure subject safety, scientific validity and data integrity of clinical research.

Clinical Operations includes Clinical Research Coordinators, Clinical Research Nurses, and Research Laboratory Technicians.

Clinical Operations team members are responsible for the coordination of assigned clinical trials, including informed consent, coordinating and conducting study-related procedures and assessments including research samples, documenting study-related activity within the patient chart, notifying principal investigators of serious adverse events and adverse events, and hosting monitoring and auditing visits.

To facilitate translational research, the laboratory technicians handle, process, and ship specimens obtained for research purposes. The data coordinators are responsible for data retrieval, storage and retention of patient research records, and uploading radiologic images to the sponsor’s central databases.

Regulatory personnel are responsible for preparing SRC and IRB submissions, including initial submissions, amendments, annual updates, and cataloging of IND Safety Reports, along with maintaining regulatory binders for each study. There is a team dedicated to startup activities, including a Study Activation Coordinator, and another team dedicated to the maintenance of trials once activated.

The Georgetown Lombardi CTO Quality Control (QC) Unit is tasked with assessing staff competency, evaluating protocol compliance, and promoting successful audits of Georgetown Lombardi studies.

A risk-based approach is used for real-time monitoring of clinical trials as well as staff-level assessments to ensure adherence to SOPs, federal, state, and other regulatory standards, requirements, and guidelines.

The QC Unit reviews first patient accrued to a trial, and works closely with the Office of Research Quality Assurance (ORQA) in DC and Corporate Compliance Quality Assurance in NJ. The QC Unit also works with research quality assurance to coordinate the conduct of external audits and draft and review audit responses. ORQA audits studies for process improvement and educational purposes or at the request of the study team to prepare for an external audit.

The financial operations of Georgetown Lombardi at Georgetown University are managed by the centralized GUMC Clinical Research Operations Office (CROO), and in New Jersey these operations are managed by Georgetown Lombardi NJ. These teams create pre-award budgets, negotiate budgets with sponsors, conduct Medicare Coverage Analysis, and facilitate the use of OnCore-created study calendars.

Disease Group and Committee Support
The Georgetown Lombardi CTO provides support to each Disease Group (DG) along with Georgetown Lombardi committees, including the Scientific Review Committee and a DSMC coordinator. DG coordinators oversee scheduling, documenting meeting minutes, and outcomes for local weekly DG meetings and monthly consortium DG meetings. The SRC and DSMC coordinators oversee respective committee and subcommittee meetings and maintain effective, efficient, and compliant procedures and documentation. 

Training and Education
The Georgetown Lombardi CTO developed education and training programs and resources for Georgetown Lombardi clinical investigators and clinical research support staff.