Frederic C. Bartter
General Clinical Research Center (GCRC)

GCRC Submission Packet

Before submitting a protocol, please come talk with us (VAH Room A703) and we will discuss how we can help you expedite the process.

Protocols to be reviewed by the GCRC Advisory Committee must be received by the first Monday of the month.  Meetings are held on the third Thursday; approval and stipulation letters are sent out the week following the meeting.  The protocol does not have to be IRB approved before being submitted to the Advisory Committee, however it must have IRB approval prior to its activation on the unit.  Please provide: 

10 complete protocol sets, including -

• The IRB submission including the protocol, IRB forms and consent forms;

• VA R&D submission forms;

• The GCRC Information sheet (PDF) (MS Word);

• Targeted/Planned Enrollment table (PDF) or (RTF)

• Budget for procedures (e.g., labs to be done outside of the VA) to be paid for by the GCRC grant;

• A statement regarding inclusion of children in the study; if not included, the reason for exclusion.  

• Data Safety and Monitoring Plan

• If you will enroll Veterans who will receive medications at a site other than the GCRC, please read the
  VA Guidelines for Investigational Drugs and complete the Contract for dispensing medications off of the GCRC

• Off-site Tissue Bank Information

• Electronic copy of all protocol materials -- if you have it -- can be emailed to Susan Stappenbeck.

10 protocol sets including only the GCRC Information sheet, the consent form, and an abstract of the protocol.

Abstract on diskette or e-mailed to stappenbeck@uthscsa.edu  

Information for submitting a protocol to the Research Imaging Core.
 

If you have any questions, please call Susan Stappenbeck at (UT) 7-4629 or (VA) 4703.  

       Category A Protocol Activation

       Category D Protocol Activation

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                        Date page last modified:  11/13/07 04:37 PM