Protocol Submission
Investigators must apply to the 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. Information for investigators and on specific Clinical Research Site (CRS) resource units can be found using specific links on this page.
Protocol Application and Review Process
1. Contact Ms. Debora Clem (404-712-1993) 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 (please see CRS contact link). The CRN staff is happy to assist you with all aspects of the protocol submission process. You may be contacted for clarifications to the submission by the CRN nursing, core lab, bionutrition or business managers for clarification during the review period. A checklist of required documents along with forms and templates can be found at the following link: http://www.actsi.org/areas/cin/protocol_submission/forms.html
2. For Grady-based protocols: In addition to materials presented in this section, click here 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 on the CRN, but all costs must be paid by the sponsor, please see CRN Cost Recovery Policy and Fee Schedule. 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. Please see Does Your New Study Need OCR Review? Let the Decision Tree Help!. Billing forms that direct charges 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 Scientific Advisory Committee. 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 any research participant can be admitted to the patient care unit.
5. All CRN protocols must be approved by the CRN Biostatistician. New protocol submissions will be pre-screened by the Biostatistics, Epidemiology & Research Design (BERD) program of the ACTSI. 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).
Administration/Contacts
Debora Clem, Administrative Director
Tel: 404-712-1993
Email: dclem@emory.edu
Khushbu Amin, Program Coordinator
Tel: 404-712- 4779
Email: kamin5@emory.edu
SAC Meeting Schedule
|
Committee
|
Meeting Date
|
Submission Deadline
|
|
SAC 2
|
January 8, 2013 (Tue)
|
December 18, 2012
|
|
SAC 3
|
February 14, 2013 (Thu)
|
January 24, 2013
|
|
SAC 1
|
March 14, 2013 (Thu)
|
February 21, 2013
|
|
SAC 2
|
April 9, 2013 (Tue)
|
March 19, 2013
|
|
SAC 3
|
May 9, 2013 (Thu)
|
April 18, 2013
|
|
SAC 1
|
June 13, 2013 (Thu)
|
May 23, 2013
|
|
SAC 2
|
July 9, 2013 (Tue)
|
June 18, 2013
|
|
SAC 3
|
August 8, 2013 (Thu)
|
July 28, 2013
|
|
SAC 1
|
September 12, 2013 (Thu)
|
August 22, 2013
|
|
SAC 2
|
October 8, 2013 (Tue)
|
September 17, 2013
|
|
SAC 3
|
November 14, 2013 (Thu)
|
October 24, 2013
|
|
SAC 1
|
December 12, 2013 (Thu)
|
November 21, 2013
|