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Clinical Trials: Oversight

All oncology-related human subject research conducted at Emory University is subject to scientific review prior to activation. Such review is a requirement for cancer centers that receive federal funding for research. On-going review over the course of the study is also required. The review and approval process begins with an investigator/faculty member who proposes the study concept. The protocol, or in some cases a detailed protocol proposal, should be reviewed by the therapeutic area managing group. The managing group should evaluate the study in terms of the specific items set forth in the Data Safety Monitoring Plan. (Managing group approval is not required, but strongly advised.)

Once the protocol is complete (drafts are not accepted), the study can be submitted to the Clinical and Translational Research Committee (CTRC). The CTRC submission form should be 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 Cancer Institute Clinical Trials Office (CTO) provides operational support to the CTRC.

The CTRC reviews studies for:

  1. Clinical need and scientific merit
  2. Adequacy of study design to address proposed study endpoints
  3. Assessment of the trial's safety
  4. Bio-statistical design
  5. Priority of study, if there are competing studies
  6. Qualification of investigator to perform study
  7. Possible accrual/projected accrual
  8. Feasibility of timely completion
  9. Appropriateness of DSMP - need for a DSMB
  10. Conflict of interest
  11. Relevance of study to mission of the cancer institute

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:

  1. approve the study as is;
  2. approve pending revisions with administrative approval possible;
  3. approve pending revisions to be reviewed by the specified committee members;
  4. resubmit for re-review;
  5. disapprove.

Once CTRC approval is granted, submission can be made to the Emory University Institutional Review Board (IRB). For those investigators who have a Winship CTO-designated regulatory affairs specialist and choose to use their expertise, the CTRC application should provide most of the information required for IRB submission. Radiation Safety, 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 (if applicable) assists the PI in responding to the IRB. The study is initiated only after written IRB approval has been received. Also, the budget and contract must be approved.

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 managing 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 Cancer Institute 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.

For inquiries about clinical trials at Winship call the Clinical Trials Office at 404-778-1868.