Investigators must apply to the Clinical Research Network (CRN) 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 CRN. 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

  1. Please contact Jane Clark at jbclark@emory.edu or 404-727-3845 to give notice of your planned protocol submission. We also suggest that you contact one of the CRN program directors to discuss your planned protocol and research needs in advance. The CRN staff is happy to assist you with all aspects of the protocol submission process. You may be contacted for submission clarifications by the CRN nursing, core lab, bionutrition, or business managers for during the review period. A checklist of required documents along with forms and templates can be found above.
  2. 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).
  3. When writing your study proposal, remember that in order for any costs of the study to be paid by the CRN, 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 CRN, but all costs must be paid by the sponsor, please see CRN Cost Recovery Policy and Fee Schedule above. The funding agency award must be reviewed with the CRN management, before the SAC review. The support requested of the CRN should only represent coverage of an unmet need. The resources committed by CRN 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 CRN 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 CRN grant may be required.
  4. All patient-oriented research and proposed budgets must be approved through the CRN SAC. The protocol must also be approved by the Emory University Institutional Review Board (IRB). Application to both the CRN 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 CRN. The IRB letter of approval, along with the IRB-approved consent form must be submitted to the CRN Administrative Office before a research participant can be admitted to the patient care unit.
  5. All CRN protocols that go through a full-SAC review must be approved by the CRN 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.
  6. 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 CRN@emory.edu. The deadline for receipt of protocol submission is three weeks in advance of the SAC meeting (see table below for meeting dates and deadlines).

SAC Meeting Schedule

Committee

Meeting Date

Submission Deadline

SAC 2

1/09/2018

12/19/2017

SAC 3

2/08/2018

1/18/2018

SAC 1

3/13/2018

2/20/2018

SAC 2

4/12/2018

3/22/2018

SAC 3

5/10/2018

4/19/2018

SAC 1

6/12/2018

5/22/2018

SAC 2

7/12/2018

6/21/2018

SAC 3

8/09/2018

7/19/2018

SAC 1

9/11/2018

8/24/2018

SAC 2

10/11/2018

9/21/2018

SAC 3

11/09/2018

10/20/2018

SAC 1

12/11/2018

11/20/2018

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