Clinical Research Review and Support
The Winship Cancer Institute of Emory University is home to multidisciplinary and interdisciplinary cancer and population sciences research. Emory University provides resources to investigators to facilitate external and internal grant funding.
The Office of Sponsored Programs, as an integral part of the University's research infrastructure, collaborates with the Emory community to identify, obtain and administer extramural funding in support of the mission of the University. The Office of Sponsored Programs ("OSP") is the university's official pre-award office.
All sponsored research (federal, nonfederal) proposals at Emory University are reviewed by OSP prior to the delivery of such items to the various funding agencies. OSP also provides services to Winship Cancer Institute by identifying funding opportunities; assisting in proposal development, proposal processing and award administration, fulfilling project requirements, and assisting in project closeout.
For additional information, please visit the OSP website at www.osp.emory.edu.
Clinical Research Review
The Clinical and Translational Review Committee (CTRC) provides scientific review of all oncology related protocols, in preparation for review by the Emory University Institutional Review Board.
All oncology clinical studies conducted at the Winship Cancer Institute are subject to a multi-step review process prior to approval and on-going review over the course of the study. The review and approval process begins with a clinical investigator/faculty member who proposes the study concept. The protocol, or in some cases a detailed protocol proposal, is reviewed by the therapeutic area Working Group. The Working Group evaluates the study in terms of the specific items set forth in the Data Safety Monitoring Plan. If the Working Group approves the study, the Working Group Chair signs the Clinical and Translational Research Committee (CTRC) submission form which has been completed by the Principal Investigator (PI). This form, along with the protocol and draft Informed Consent document, are submitted to the CTRC for review. The Winship Clinical Trials Office (CTO) provides operational support to the CTRC.
The proposed study is reviewed by designated members of the CTRC, and their review is presented to the entire committee. Following review and discussion, the CTRC votes on the proposal:
approve the study as is
approve pending revisions with administrative approval possible
approve pending revisions to be reviewed by the specified committee members
resubmit for re-review
Following CTRC approval, the protocol and supporting materials, along with the Informed Consent document, are sent to the CTO or individual department's regulatory staff where a submission package is prepared for consideration by the Emory University Institutional Review Board (IRB). Biosafety Committee, Conflict of Interest, and Winship Monitoring Office reviews are obtained as needed. The IRB reviews the protocol and if questions are raised or revisions are required, the CTO or the individual department's regulatory staff assists the PI in responding to the IRB. The study is initiated only after written IRB approval has been received.
Once an IRB approval has been obtained, direct communication is made with the study sponsor and the PI regarding screening and potential enrollment of patients. If a new patient is identified as appropriate for the study, the PI overviews the study with the patient and notifies the research nurse. The research nurse will further review and answer questions of any study related activities or the clinical trial with the patient. A relationship is now established between the patient and the research nurse once the Informed Consent has been obtained and screening appointments are scheduled such as CT exams, laboratory, etc. The research nurse then reviews all the screening records necessary for inclusion into the clinical with the PI for approval. And so begins the involvement of another team member into the care of a clinical trials patient.
During the course of the study, conduct and progress are reviewed. The Working Group that approved the trial is charged with reviewing progress. The Monitoring Committee annually reviews all protocols. These reviews are in addition to the reporting requirements established by the IRB, which may include semi-annual as well as annual reports. If the study is covered by the monitoring policy, it is monitored in accordance with that policy, with monitoring being performed by the CTO. Reports of all monitoring activities are reviewed by the Monitoring Committee. If the Monitoring Committee determines that an audit of the study should be conducted, they will appoint auditors (who may be members of the Winship faculty not involved with the study, or outside experts) to conduct such an audit. The Monitoring Committee will establish the scope of the audit and provide support. In addition, external sponsors (e.g., pharmaceutical companies, Cooperative Groups, and outside institutions) monitor studies they sponsor and may audit them according to their established policy. Audits/inspections may also be conducted by the Food and Drug Administration (FDA) in the case of studies using drugs covered by an FDA-approved Investigational New Drug (IND) application or devices covered by an FDA-approved Investigational Device Exemption (IDE) application.
Clinical and Translational Research Committee Application
All protocols are reviewed by the Working Group and Clinical Translational Research Committee (CTRC). The application process is designed to be a tool for the investigator(s), to ensure that the many facets surrounding the initiation of clinical trials are carefully thought through, understood and agreed upon by all of those involved in the trial before the approval process begins.
The form is designed in such a way that a completed form will provide the regulatory department with all of the information needed for IRB submission, and application can be made to the IRB immediately following CTRC approval.
Please complete this application electronically, print it, and obtain the necessary signatures.
Form 1 CTRC Application
Form 2 CTRC Application (Includes CTO Cover, SPAF)