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John Sealy Hospital, 5th floor, J5A Outpatient, J5B Inpatient, J508 Administrative Offices, route 0264, Voice: 409-772-1950, Fax: 409-772-8097 |
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| GCRC Application Review Process |
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View/Read: • GCRC Application Instructions • DSMP Download: • Resource Request Form (GCRC Application Packet and Instruction) Link to: Last Modified: 10/11/03 |
Timing of GCRC and IRB submissions. The same package may be submitted simultaneously to both the IRB and the GCRC for review. (The cover memo may be addressed to both.) This enables investigators to receive comments from both the IRB and the GCRC at approximately the same time. It is suggested that investigators wait for their protocol critique from both bodies and address both sets of critiques at one time. Alternatively you may submit your protocol to the GCRC after obtaining IRB approval. The protocol review schedule. There is a deadline each month for submission of new protocols. Protocols submitted before the monthly deadline will be reviewed at that month’s meeting. The schedule of monthly deadlines for submission and for meetings of the GCRC Advisory Committee (GAC) is posted on the GCRC website: http://www.utmb.edu/gcrc/committee/MeetSched.htm . |
| Applications must be received by the GCRC by the 23rd of any month in order for them to be reviewed by the GAC the following month. For example, applications received by the GCRC by 23rd Jan will be reviewed in the GAC meeting of February. Applications received on the Jan 24th will be reviewed in the GAC meeting of March. The GCRC Advisory Committee meets the third Wednesday of each month to review project proposals. |
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Review process and resubmissions. Submissions are reviewed
initially by the GCRC Staff to be sure all required items have been provided.
Missing information may delay the review and approval. Two members of the GAC, as well as the Biostatistician and Research Subject Advocate prepare written reviews of each protocol. These reviews, and any additional considerations discussed at the meeting, are the basis for a motion to approve, defer or disapprove the application with or without stipulations. Applications may be revised and resubmitted. |
The investigator can begin to use GCRC resources only after
approval of their submitted protocol and when the following are on file in the
GCRC administrative office:
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| If you have requested ancillary support for your study, please note that funds for ancillaries are dependent on the budget appropriated by the GCRC Program of the NCRR, the number of active protocols requiring ancillaries and their priority within the UTMB GCRC. Depending on the levels of NIH funding to our GCRC and your protocol score, the GCRC may not be able to pay for full ancillary costs requested for this project. You will receive notification of the level of support you will receive from the GCRC. |
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