Georgetown University’s Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center, seeks to prevent, treat and cure cancers by linking scientific discovery, expert and compassionate patient care, quality education and partnership with the community — guided by the principle of cura personalis, “care for the whole person.” Georgetown Lombardi is the research engine driving clinical cancer research at MedStar Health in the D.C. Metro area and northern New Jersey.
Training
For all clinical research staff in DC, the following trainings must be completed, at minimum:
For members of the Clinical Operations team, you will work with your direct manager to complete the MedStar Systems Access Form to gain access to the appropriate clinical applications, including the Electronic Medical Record (EMR), MedConnect.
Clinical Trials Management System
OnCore is the Clinical Trials Management System (CTMS) to integrate research activity administered by Georgetown Lombardi, Georgetown University Medical Center, MedStar Georgetown University Hospital, and MedStar Health facilities/all affiliated and satellite locations. The system is designed to serve the needs of research teams to support the continued strengthening of standards for efficiency, safety, quality and compliance.
In order to gain access to OnCore, your manager will email the MedStar Research Systems Coordinator to schedule training which includes, but is not limited to, Subject Administration and Protocol Build Training.
Any new oncology treatment clinical trial must first route through the Disease Group (DG) for initial review. Please ensure you include the Study Activation Coordinator on initial communications: crmoregstartup@georgetown.edu
Confidential Disclosure Agreement (CDA): Typically required by Industry-sponsored studies to receive protocol and relevant documents for review. This is handled by the Associate Senior Director for Licensing and Intellectual Property in the Technology Commercialization office at Georgetown.
Feasibility Survey/Questionnaire (FSQ): While not always a part of the process, when it is, this is often when there is an Industry sponsor with or directly after the CDA. This document requires responses from multiple teams at the site to provide the sponsor with a comprehensive understanding of how prepared the site is for the study in question. This does not occur for National studies or IITs.
Pre-Site Selection Visit: This is a meeting scheduled after the CDA (if applicable) has been signed by both parties and allows the Industry the opportunity to present the study to the intended/interested PI while giving the PI a space to ask questions and delve deeper into the study. The study protocol may be shared with the PI (post-CDA completion) either directly before or after the PSSV. This does not occur for National studies or IITs.
Initial Study Materials Received: For Industry-sponsored studies, it is at this point that the complete packet of initial study materials is sent to the site with documents including:
Most current study protocol
All Informed Consent documents
Initial study budget draft
Initial Clinical Trial Agreement (CTA)
Investigator Brochure(s)
FDA Exemption Letters (if applicable)
Disease Group Presentation & Prioritization Rubric: This event takes place post-PSSV once the PI has determined that they have an interest in the study and believe it is a good fit for the site. The PI presents an overview of the study to a group of their colleagues (Disease Group – DG), fielding questions and receiving feedback. These comments and assessments are documented in a Prioritization Rubric which results in a score that determines if and how the study moves forward at the site.
Disease Group Cover Letter (DGCL): A required document if the DG decides to move forward with the protocol after presentation and completion of priority rubric.
Study Start-Up Packet: This document provides an overview of the required documents in order to consider sending a study to the Scientific Review Committee.
Disease Group Cover Letter (DGCL)
Study Prioritization Rubric
Study Protocol
Study Informed Consent Documents
Scientific Committee Review: The Scientific Committee meets once a month to review studies that have been submitted to it by each of the DGs. The Committee makes determinations based on a number of factors and has the ability to request additional information or ask questions. Ultimately, the Committee makes a decision on whether or not a study will be permitted to move forward.
ICF Negotiations: Once Scientific Committee approval has been obtained, a Regulatory Coordinator will begin work reviewing and modifying the study consent documents and other patient facing materials before sending them back to the originator (e.g., Industry sponsor) for review and counter-editing. In the end, both parties will agree on the final materials which accompany the IRB submission.
Central IRB Review: In instances where a Central IRB is being utilized, the study will be submitted by the site, reviewed, modified or responded to as necessary, and approved.
Local IRB Review: If there is no Central IRB, then the Local IRB will perform all reviews and its approval will gate moving forward. In instances where there is a Central IRB, once Central IRB approval has been obtained, the Local IRB will review __
Radiation Safety Board Review: When applicable, study materials will also be submitted to, and reviewed by, the Radiation Safety Board to ensure that there are no exposures that exceed appropriate or safe limits.
Study Calendar Build: Once Scientific Committee approval has been obtained, the study protocol and consent documents will be used to build out a study calendar. For Industry-sponsored studies, this step occurs concurrently with ICF Negotiations. In the case of a National study, this step takes place directly after step 5 and is completed prior to submission to the Scientific Committee. In the case of an Investigator Initiated Trial (IIT), this step is started as soon as the protocol and consent materials are finalized and the DG makes the determination to move forward with the study.
Medicare Coverage Analysis (MCA): Once the study calendar has been created, an MCA is performed to assess which components of the study will be covered by Medicare/insurance.
Budget Negotiations: For Industry-sponsored studies, the study budget will require edits back and forth between the site and sponsor representatives until a final budget is agreed upon.
Clinical Trial Agreement (CTA) Negotiations: For Industry-sponsored studies, the CTA governing the study will require edits back and forth between the site and sponsor representatives until a final agreement is reached. This document will have the final budget incorporated into it prior to being circulated for signatures, so its completion is gated by the conclusion of budget negotiations, though it can begin at the same time as the MCA.
Site Initiation Visit (SIV) Scheduling: For Industry-sponsored studies, once all necessary IRB and Safety board reviews have taken place and the budget and CTA documents have been finalized, the SIV can be scheduled. The SIV is the formal training event where the sponsor and all study staff will run through the study procedures and ensure that all final questions are addressed and that a complete understanding of the study is had by the study staff.
Site Activation Letter (SAL) Receipt: For Industry-sponsored studies, the site must wait to receive an SAL Letter, Document, or Email from sponsor which indicates that they approve the site to open to accrual.
Essential Documents Completion: Once the SIV has been completed, Training logs and Delegation of Authority documents will circulate so that all study team members (SIV attendees) can sign off to indicate their attendance and understanding of all study procedures.
Study Calendar Sign-Off: Once the SIV has been completed, the Lead Study Coordinator must review the Study Calendar and sign off on it to indicate that it has been created accurately and correctly lays out the study procedures.
Institutional Office (IO) Sign-Off: Once all previous steps have been completed, a qualified representative will review all study materials and proceedings thus far and confirm that all is present and nothing is missing. Should they deem all things accurate, they will sign off on the study to indicate that it is ready to open to accrual.
Open to Accrual: This is a formal step in which the study is given a status of “Open to Accrual”. At that time, the site is able to put patients onto the study.
