Protocol Submission


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 (EUH, EUHM, Grady)

For current or future requests, please complete our SAC application online through REDCap. You will be prompted to upload a copy of the study protocol, a draft of the day-to-day orders, a 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.

GCRC Study Templates

Application Steps:

1. Submit inquiry through our SAC application

2. A GCRC team member will reach out to the study team within 2-3 business days for any clarifications from the SAC application

3. Upon receipt of all required documents, the SAC application will be routed through our internal review process. 

  • Program director will review application and 1) Expedite SAC application or 2) Require SAC application for full SAC review. 
  • Leadership of each requested service (nursing, core laboratory, etc.) will review the SAC application to determine study needs.
  • Following the reviews of requested services, our business manager will create a budget for the entire study lifecycle.
  • Final review will be completed by the SAC chair.

4. Once the study has been approved, the study team will be notified by the GCRC program coordinator. An official email confirmation with the SAC approval letter, GCRC budget, and Protocol Initiation Checklist will be sent to the principal investigator (PI) and study coordinator (CRC).

5. Study team will receive an automated email from REDCap to complete the Study Staff Information Form.

6. Upon completion of the Study Staff Information form, a final automated email from REDCap will be sent to the study team to complete the CR-Assist Study Set Up form (Form is required to build out your study and associate visits in CR-Assist).

7. After completion of the Protocol Initiation Checklist, Study Staff Information form, and CR-Assist Study Set Up form, the study team will contact the GCRC program coordinator to schedule a roundtable meeting.

8. Following the roundtable meeting, the study team is responsible for addressing any action items discussed during the roundtable meeting.

9. After all necessary/applicable documents (day-to-day orders, lab manual, speedtype confirmation, etc.) are finalized, the study initiation process will begin. 

We look forward to assisting you with your research!

Protocol Application and Review Process (Pediatrics)

More to come! For now, please contact us at pruteam@choa.org or call 404-785-0400 for more information.

Protocol Application and Review Process (UGA)

The Clinical and Translational Research Unit provides funded and non-funded investigators and their research teams with resources, dedicated outpatient space and research personnel to develop and conduct clinical and translational research studies.  Research nurse support may be requested for studies conducted outside the CTRU in community hospitals and clinics.

Studies that utilize the CTRU require Institutional Review Board (IRB) and CTRU Scientific Advisory Committee (SAC) approvals. Although these are separate committee approvals, the approval process occurs concurrently and is managed through the UGA IRB’s electronic web application (eResearch Portal). CTRU staff are available to help develop and conduct your research study at each step. Please contact us to determine how the CTRU can support your research and educational needs.

  • To learn more about the research capabilities and support services available through the CTRU, please visit our Services
  • For specific inquiries, please contact us.
  • Tour the CTRU. We welcome UGA and community investigators as well as university students and trainees to visit the CTRU to learn more about the unit’s research capabilities and to meet the research  staff. The CTRU is located on the UGA Health Sciences Campus. Please contact us to set up a tour.
  • For an estimate of fees for our services, please contact us. Based on the merit of your proposed research, pilot grants or internal funding may be available.

Protocol Application and Review Process (Morehouse)

The CRC Clinical Resources Application is a compliance tool requesting the use of the center, its resources and the cores of the R-CENTER and Clinical Research Network (CRN).

A completed application must be submitted via the R-CENTER web portal to the Clinical Research Center (CRC) for approval by Scientific Advisory Council (SAC) and the CRC Medical Director prior to initiation of any clinical trial/protocol in the CRC.

The application for project initiation is located on the R-CENTER Web portal, under the "Home" tab. Select "CRC Clinical Resources Application" or to submit a Clinical Resources Application click here.

The CRC Protocol Implementation Team meetings are held twice per month and applications will be screened at that time. A follow-up roundtable discussion will be scheduled within 7-10 business days.

New studies that are initiated by the Principal Investigator will follow the process as outlined here.

New studies that are Industry- Funded with follow the process outlined here: Procedure for Industry-Funded Clinical Trials

All scheduling of participant days must be done with the CIN Schedule Administrator.  For more details and forms go to  Clinical Research - Assist (CRAssist).

Contact

Jeb Williams

gcrc@emory.edu