Protocol Review and Monitoring Committee

All cancer relevant clinical research studies conducted at the Winship Cancer Institute, Emory University and subject to IRB review are subject to a multi-step review process prior to approval and on-going review over the course of the study through the Winship PRMC. 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 feasibility review and Data Safety Monitoring Plan (DSMP) assigning a priority protocol assessment score. If the Working Group approves the study, the Working Group Chair signs the PRMC 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
• disapprove

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 Data and Safety Monitoring Committee (DSMC) or Quality Management (QM) 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 Data and Safety Monitoring Committee (DSMC) 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 DSMC. If the DSMC 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 DSMC 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.

All protocols are reviewed by the Working Group and the Protocol Review and Monitoring Committee.

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 the information needed for IRB submission, and concurrent submission to the PRMC and IRB is required. The initial study section in the eIRB must be completed in order to generate and IRB number. 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.

To access the online application, you must be connected to the Emory network or VPN. Log in with your Emory Net ID.

The long-term goal of the CTO is to advance progress in cancer care through the support of high-quality, high-impact clinical research by Winship Cancer Institute members. The focus of the CTO is to help develop and support institutional clinical research studies, particularly phase I and institutional studies. In 2009, the Phase I Clinical Trials Unit opened and is dedicated to advancing cancer research through a singular focus on caring for patients enrolled in phase I clinical trials.

The CTO supports clinical research at other Emory University Hospital sites, including Emory University Hospital Midtown, Emory Saint Joseph's Hospital, Emory Johns Creek Hospital, and Emory Proton Therapy Center. Additionally, support is provided at other area facilities where Emory investigators conduct clinical trials, including Atlanta VA Medical Center and Grady Memorial Hospital. Investigators represent the Emory University School of Medicine Departments of Hematology & Medical Oncology, Medicine, Pediatrics, Surgery, Radiation Oncology, Urology, and Pathology; the Departments of Behavioral Science & Health Education in the School of Nursing; and the Departments of Epidemiology and Biostatistics in the School of Public Health. The CTO has supported clinical research from Emory University that has led to numerous publications since 2002.

The CTO manages the overall process of subject screening, consent, registration, data entry and regulatory document submission and management for clinical research studies involving cancer patients. To achieve the goals, the CTO pursues the following specific objectives:

1. To support safe and ethical conduct of innovative and transformative clinical research.
2. To increasing awareness and trial access for patients in the catchment area, emphasizing underrepresented population.
3. To provide infrastructure support for the development and implementation of human clinical research protocols relevant to cancer.
4. To provide the disease management teams with administrative support to facilitate subject screening, consent, registration, study-specific tests and treatments, response and toxicity assessment, and data entry.
5. To provide disease management teams with regulatory support to ensure compliance with GCP, IRB, FDA, and other regulatory agencies.
6. To monitor overall accrual of participants on therapeutic and non-therapeutic cancer-related clinical trials and provide support for the Cancer Institute Director and leaders of the Scientific Programs in monitoring accrual to specific protocols.
7. To support the Protocol Review and Monitoring Committee (PRMC) in executing the functions of the Protocol Review and Monitoring System (PRMS).
8. To support the Data and Safety Monitoring Committee (DSMC) in executing the Data and Safety Monitoring Plan (DSMP).
9. To provide education and training for staff and faculty involved in clinical research.
10. To disseminate information on active clinical trials involving cancer patients to the Emory community and patients and referring physicians in Georgia and bordering states.

The CTO is the central clearinghouse for the initiation and registration of clinical protocols involving cancer patients. It is authorized by the executive director of the Winship Cancer Institute to:

• support the disease management teams that include clinical investigators focused on specific cancer types
• monitor overall accrual and accrual to each of the protocols open at Winship
• serve as a liaison with Emory School of Medicine Clinical Trials Office that negotiates budgets for clinical trials and ensure billing compliance
• serve as a liaison with the Office of Sponsored Projects that negotiates contracts with external sponsors of clinical trials at Emory.

The CTO has developed policies and procedures to facilitate centralized management of cancer clinical studies across all departments in which subjects may be enrolled on cancer clinical trials. The CTO provides disease management teams with regulatory support to ensure compliance with GCP, the IRB, FDA, and other regulatory agencies. The CTO staff monitors study procedures to ensure regulatory compliance and provides regular instruction to new and current staff in these areas. Training of clinical research staff across all Winship is assisted and supervised by the Director and their leadership staff. The creation of these teams has stimulated greater interaction, communication and teamwork among the faculty and research staff facilitating clinical trials. Additionally, this structure has increased efficiency and streamlined processes.