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Requirements for Using the GCRC

View/Read:

GCRC Application Instructions

DSMP

GCRC Notices

Download:

Protocol PHS 398 Template

Resource Request Form

Link to:

NIH Biosketch Form

IRB Human Subjects Training

IRB Forms

Other Useful Links

 Last Modified: 10/11/03

 

What is the GCRC Approval Process? The GCRC approval process includes review by the GCRC Advisory Committee (GAC), followed by an Initiation Meeting with the GCRC staff. Proposed utilization of GCRC resources for research must be described in the reviewed protocol that is approved in advance by the GCRC and the IRB.

 

Who can be a GCRC Investigator? The Principal Investigator (PI) must be an active UTMB faculty member, student, resident, or postdoctoral research fellow. Scientists not at UTMB may be listed as co-investigators, or they may be named and their collaborative involvement described in the text of the protocol.

  • At least one investigator must be an active faculty member at UTMB.

  • At least one investigator must be a physician and member of the UTMB medical staff. One investigator must be designated to provide clinical coverage and is responsible for the medical aspects of the study.

  • Only one investigator can be designated as the PI.

  • All those listed as protocol investigators must also be approved as investigators by the IRB and have completed UTMB’s on-line course on human subjects knowledge assessment. This can be accessed at: http://research.utmb.edu/irb/eval/  (Non-UTMB investigators and collaborators who are not listed as co-investigators on the protocol are not required by the GCRC to have passed the on-line course, or the equivalent at their institutions if they will not have access to data generated by the study. However, UTMB may have such a requirement in some instances when, for example, a subcontract exists between UTMB and another institution.)

What studies can be done on the GCRC? The GCRC gives highest priority to investigator initiated projects that are funded by NIH. Investigator initiated studies funded by other external sources, and unfunded pilot studies that are likely to lead to external funding, are also given high priority. Up to about 20% of GCRC studies may be industry-initiated clinical trials (“D” studies).

 

The links provided below will help you in this process...

(Download this set of instructions)

BEFORE your Protocol can be Approved
AFTER your Protocol has been Approved

REQUIREMENTS FOR USING THE GCRC

INVESTIGATOR’S RESPONSIBILITIES

TYPE OF STUDY

STUDY INITIATION

GCRC APPLICATION PACKET & INSTRUCTIONS*

ACKNOWLEDGING THE GCRC

GCRC ADMINISTRATIVE STAFF

ANNUAL REPORTS & RENEWALS

GCRC APPLICATION REVIEW PROCESS

CLOSING A GCRC PROTOCOL

*download/save file to your computer