Protocol Submission

Protocols can be submitted to the PCRC at the same time they are submitted to the IRB. If an investigator submits a proposal for consideration to the GCRC Advisory Committee he/she should indicate PCRC utilization by checking the appropriate box on the IRB application.
Please Submit the Following:

1. PCRC application form:
   
• · Protocol identification (The Project Title must be the same as that on the IRB submission form)
  
• IRB Status
  
• Study Category:
• A - Investigator-initiated study. Patients are enrolled on protocols in which research overnight stays or outpatient visits are solely for research purposes. The GCRC/PCRC or an investigator's research funds will pay all costs. Industry my provide partial funding to the investigator (documentation required).
  
• B - Research subjects who require hospitalization or outpatient visits for diagnosis or treatment according to established standards of care. The patient or his/her insurance is responsible to cover the cost of standard medical care. The GCRC/PCRC grant pays only for research related charges.
  
• D - Industry sponsored research project. Research subjects admitted to a study sponsored by industry. PCRC services are requested on a fee for service basis. The industry sponsor pays all charges including patient care and ancillary costs.
  
• Study Abstract on disk (a brief description of the study in layperson's language)
  
• Current Grant support for the project
  
• Need for the PCRC 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 PCRC resources
  
3. OR -- In lieu of the description of the project as requested in item #2, 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 (Final IRB approvals must be provided in writing PRIOR TO initiation of any study on the PCRC. A copy of the IRB approval and consent form MUST be forwarded to the PCRC Administrative offices.)
   
7. Clinical trial budget