Protocol Submission

Preparing the Proposal for GCRC Submission

Protocols can be submitted to the GCRC at the same time they are submitted to the IRB. The proposal is submitted for consideration by the GCRC Advisory Committee.

Please Submit the Following:

1. GCRC application form:
   
   • Protocol identification (Please Note that the Project Title must be the same as that on the IRB submission form)
   • IRB Status
   • Study Category: 
     • A - Investigator-initiated study, protocols in which research patient days or outpatient visits are solely for research purposes. All costs will be paid by the GCRC/PCRC or an investigator's research funds. 
     • B - Research subjects who require hospitalization or outpatient studies for diagnosis or treatment according to established standards of care. The cost of standard medical care is paid by the patient or a third-party payor. The GCRC/PCRC grant pays for charges related to only the research performed..
     • D-Research subjects admitted to a study for industry-sponsored research. All charges including patient care and ancillary costs are paid by the industry sponsor. 
   • Study Abstract on disk (a brief description of the study in layperson's language)
   • Current Grant support for the project
   • Need for the GCRC resources
   • Number/gender of subjects
   • Age range of subjects
   • Purpose of project

2. A description of the project including the following elements:
• Hypothesis and specific aims
• Background and preliminary information (1-2 pages suggested, including references)
• Research design and methods (2 page limit)
• Biostatistical design and analysis (sample size justification, data analysis plan)
• Need and justification for utilization of GCRC resources

3. OR -- In lieu of the description of the project as requested in item #3, a copy of the relevant full grant application may be submitted.
4. IRB approved or pending protocol form
5. IRB approved or pending Consent form(s)
6. IRB approval notification (IRB approvals must be obtained in writing PRIOR TO initiation of any study on the GCRC. A copy of the IRB approval MUST be forwarded to the GCRC Administrative offices.)
7. Clinical trial budget

.