Protocol Submission
Investigators must apply to the CIN 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 Interaction Site (CIS) 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 CIN Program Directors to discuss your planned protocol and research needs in advance (please see CIS contact link). The CIN 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 CIN 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 CIN, 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 CIN, but all costs must be paid by the sponsor, please see CIN Cost Recovery Policy and Fee Schedule. The funding agency award must be reviewed with the CIN management, before the SAC review. The support requested of the CIN should only represent coverage of an unmet need. The resources committed by CIN 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 CIN 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 CIN grant may be required.
4. All patient-oriented research and proposed budgets must be approved through the CIN Scientific Advisory Committee. The protocol must also be approved by the Emory University Institutional Review Board (IRB). Application to both the CIN 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 CIN. The IRB letter of approval, along with the IRB-approved consent form must be submitted to the CIN administrative office before any research participant can be admitted to the patient care unit.
5. All CIN protocols must be approved by the CIN 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 CIN 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
|
MEETING |
DATE |
Submission Deadline |
|
SAC 2 |
January 10, 2012 |
December 20, 2011 |
|
SAC 3 |
February 9, 2012 |
January 19, 2012 |
|
SAC 1 |
March 8, 2012 |
February 16, 2012 |
|
SAC 2 |
April 10, 2012 |
March 20, 2012 |
|
SAC 3 |
May 10, 2012 |
April 19, 2012 |
|
SAC 1 |
June 14, 2012 |
May 24, 2012 |
|
SAC 2 |
July 10, 2012 |
June 19, 2012 |
|
SAC 3 |
August 9, 2012 |
July 19, 2012 |
|
SAC 1 |
September 13, 2012 |
August 23, 2012 |
|
SAC 2 |
October 9, 2012 |
September 18, 2012 |
|
SAC 3 |
November 8, 2012 |
October 18, 2012 |
|
SAC 1 |
December 13, 2012 |
November 22, 2012 |