Investigators must apply to the Participant & Clinical Interactions (PCI) 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 PCI. 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. 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 PCI Program Directors to discuss your planned protocol and research needs in advance. The PCI staff is happy to assist you with all aspects of the protocol submission process. You may be contacted for submission clarifications by the PCI 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 PCI, 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 PCI, but all costs must be paid by the sponsor, please see PCI Cost Recovery Policy and Fee Schedule above. The funding agency award must be reviewed with the PCI management, before the SAC review. The support requested of the PCI should only represent coverage of an unmet need. The resources committed by PCI 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 PCI 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 PCI grant may be required.
  4. All patient-oriented research and proposed budgets must be approved through the PCI SAC. The protocol must also be approved by the Emory University Institutional Review Board (IRB). Application to both the PCI 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 PCI. The IRB letter of approval, along with the IRB-approved consent form must be submitted to the PCI Administrative Office before a research participant can be admitted to the patient care unit.
  5. All PCI protocols must be approved by the PCI 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 email your submission files to cnetwor@emory.edu. If your file is too large to send electronically, please copy your protocol/attachments onto a CD and submit to the CRN Administrative Office in Room GG-23, Emory University Hospital. 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 January 10, 2017 12/22/2016
SAC 3 February 9, 2017 1/19/2017
SAC 1 March 14, 2017 2/21/2017
SAC 2 April 11, 2017 3/21/2017
SAC 3 May 11, 2017 4/20/2017
SAC 1 June 13, 2017 5/13/2017
SAC 2 July 13, 2017 6/22/2017
SAC 3 August 8, 2017 7/18/2017
SAC 1 September 14, 2017 8/24/2017
SAC 2 October 10, 2017 9/19/2017
SAC 3 November 9, 2017 10/19/2017
SAC 1 December 12, 2017 11/21/2017

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