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 and assigns a priority score. If the Working Group approves the study, the Working Group Chair signs the Protocol Review and Monitoring Committee submission form which has been completed by the Principal Investigator (PI). This form, along with the protocol, supporting documentation and draft Informed Consent document, are submitted to the committee for review. The Winship Clinical Trials Office (CTO) provides operational support to the committee.
The proposed study is reviewed by designated members of the committee, two investigators, a statistician and the committee Chair and Co-Chair, and their review is presented to the entire committee. Following review and discussion, the committee 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 committee 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 Internal 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 trials 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.
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 concurrent submission to the Protocol Review and Monitoring Committee and IRB is strongly encouraged. Once committee approval is granted, ancillary approval will be granted within the IRB system. The IRB number for the study will be needed to facilitate the approval.
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