Application Process

To the Principal Investigator/Project Representatives

The GCRC Advisory Committee reviews all protocols/applications for scientific and funding merit. All NIH funded research is given preference. Before beginning your GCRC protocol application, please read the following instructions carefully.

PLEASE SUBMIT THE FOLLOWING DOCUMENTS:

1. Research Protocol addressing the following:
   • Abstract
   • Specific Aims
   • Background/Significance
   • Preliminary Studies
   • Experimental Design/Methods (include a flow sheet or schema)
     The protocol section must contain enough detail to support the biostatistical methodology
   • Statistical Design
   • Detailed Data Safety Monitoring Plan (all studies) and or Data Safety Monitoring Board (Phase I and II) studies
   • Literature Cited
   • The NIH requires that all age subjects and minorities be included in research. Submit the PHS 398 NIH format tables for race/ethnicity.
     NOTE: If you are not including children, women and or minorities, provide an explanation.
   • Biographical Sketch and Other Support of PI and all Co-Investigators (PHS 398 NIH format)
   • Short paragraph explaining rationale/justification for the use of GCRC resources needed
2. Institutional Review Board documentation (IRB): A copy of either of the IRB application materials
3. A copy of the IRB approval letter (full approval) and current stamped Informed Consents
4. GCRC Needs Summary Form (provided by the GCRC)
5. Funding Support – The GCRC Advisory Committee must review all of the funding support provided for the study before deciding on additional support from the GCRC grant. Please provide: the Notice of Grant Award, the contract and/or subcontract, and any other funding documents from any sponsors for the project. For industry-supported studies, a copy of the Financial Agreement and budget must be provided.

EMAIL/DELIVER/INTER-OFFICE/CALL FOR PICKUP COPIES TO: When possible, send the documents via email with the paperwork as file attachments to:

University of Miami School of Medicine
General Clinical Research Center

Attention: Administrative Personnel
1120 NW 14 Street (CRB)
Room 727
Miami, FL 33136
Office: 305/243-5012
Fax: 305-243-1428
Email: PDavila@med.miami.edu

Review and Implementation Process

Your protocol, including budget and funding source information, must be submitted, reviewed, and approved by the GCRC Advisory Committee (GAC) before subjects can utilize the GCRC resources.

Once you have received the GAC approval, contact the GCRC nursing manager or designee, to arrange for an in-service to implement your protocol. Our nursing manager can be reached by telephone at 305-243-5012. All outpatient visits are scheduled by the nursing manager or its designee.

Memorandum of Understanding

If you utilize any GCRC resources, you must acknowledge the GCRC in all pertinent reports and publications derived from the research for inclusion in the annual report. All reports and publications should contain the following or a similar statement:

This investigation was supported by the University of Miami, General Clinical Research Center. Copies and/or reprints of the publication should be sent for inclusion in the annual report to:

Patricia Davila
GCRC Administrative Director
1120 NW 14 Street (CRB)
Room 727
Miami, FL 33136

GCRC Annual Updates and Reports

Each year the GCRC is required to submit to the Dean the Annual Progress Report in June on all research supported by the GCRC. You will receive requests of GCRC resources for the next funding year and to report on the progress of your research for the current year.

For Information or Questions, Contact:

Patricia Davila
GCRC Administrative Director
Office: 305-243-5012
Fax: 305-243-1428
Email: PDavila@med.miami.edu