Investigators must apply to the Georgia CTSA Clinical Research Centers (GCRCs) Scientific Advisory Committee (SAC) for use of the inpatient and/or outpatient nursing units and/or use of resources provided by the Core Laboratory and Bionutrition services. Investigators from Emory University, Morehouse School of Medicine, Georgia Institute of Technology, and University of Georgia are eligible to request resources from the GCRCs. All other designated Georgia CTSA investigators who have representation from one of these institutions as part of their investigator team are also eligible. Information for investigators and on specific Clinical Research Sites can be found here.

Protocol Application and Review Process

Protocol Application and Review Process

  1. Please complete the SAC application online in REDCap, linked here. You will be prompted to upload a copy of the study protocol, a draft of the day-to-day orders, consent form, etc. If you have any questions about this form, please email GCRC@emory.edu. We offer an expedited review process for qualifying studies. You will be notified if your protocol requires a full SAC review.
  2. For UGA protocol submissions please email Bradley Phillips, Pharm D-bgp@uga.edu.
  3. For MSM protocol submissions, please click here to be directed to the application submission page. 
  4. When writing your study proposal, remember that in order for any costs of the study to be paid by the GCRCs, projects must be either original hypothesis-driven projects or clearly intended to obtain pilot data for a hypothesis-driven project. Industry-sponsored research may be performed in the GCRCs, but all costs must be paid by the sponsor, please see GCRCs Cost Recovery Policy and Fee Schedule above. The funding agency award must be reviewed with the GCRCs management, before the SAC review. Please contact Debora Clem dclem@emory.edu or 404-712-1993 for budget review.
  5. The support requested of the GCRCs should only represent coverage of an unmet need. The resources committed by GCRCs cannot duplicate support from other sources. It is the responsibility of the investigator to ensure that what is requested does not duplicate existing sources of support, but the GCRsC management will work with you to review your award(s) during the review process. Emory's Office for Clinical Research (OCR) may also need to review your proposal. Billing forms that direct charge to your award as well as billing forms directing charges to the GCRCs grant may be required.

  6. Please contact Jane Clark at jbclark@emory.edu or 404-727-3845 with any questions regarding your protocol submission. We also suggest that you contact one of the GCRCs program directors to discuss your planned protocol and research needs in advance. The GCRCs staff is happy to assist you with all aspects of the protocol submission process. You may be contacted for submission clarifications by the GCRCs nursing, core lab, bionutrition, or business managers during the review period. A checklist of required documents along with forms and templates can be found above.
  7. For Grady-based protocols: In addition to materials presented in this section, see above for the additional form required by the Grady Research Oversight Committee (ROC).
  8. All patient-oriented research and proposed budgets must be approved through the GCRCs SAC. The protocol must also be approved by the Emory University Institutional Review Board (IRB). Application to both the GCRCs and the IRB may be made simultaneously. The actual research protocol submitted to the IRB does not need to be modified for submission to the GCRCs. The IRB letter of approval, along with the IRB-approved consent form must be submitted to the GCRCs Administrative Office before a research participant can be admitted to the patient care unit
  9. All GCRCs protocols that go through a full-SAC review must be approved by the GCRCs Biostatistician. New protocol submissions will be pre-screened by the Biostatistics, Epidemiology, & Research Design (BERD) program of the Georgia CTSA. The investigator will be contacted should any questions or concerns arise with the statistical design and analysis plans.

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