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GCRC Application Approval _________________ |
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The Advisory Committee has the responsibility for
review, approval, and oversight of all research projects requesting GCRC support. The chairman of the committee is John R. Hoidal, M.D. The committee
meets monthly to evaluate proposals based upon scientific merit and need for center resources. Approved research projects are prioritized using
these two factors. The committee is responsible for the designation of the category of inpatient days and outpatient visits for each research project
proposed to the center as category A, B, or D, including the classification of research sponsored by industry. |
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The GCRC Director assigns a primary reviewer to each protocol submitted. The reviewer
critiques the study verbally and in a written report on the qualifications of the principal investigator, proposed science, suitability of study design, strengths and weaknesses,
and need for center resources.
If the Committee approves the protocol with no changes, the investigator can begin to use GCRC resources immediately (assuming IRB approval has been granted). If the
study is not approved as submitted, the protocol will be returned to the investigator with specific suggestions for revision. Consideration following resubmission is usually expedited.
After each meeting, the principal investigator of each study reviewed is sent a written notice indicating the action taken by the committee at the meeting.
No studies requiring center support can take place without Advisory Committee approval, except when temporary approval is given by the chairman for urgent
studies created by an unexpected opportunity to study unusual patients.
A protocol can be reviewed simultaneously by the IRB and the Advisory
Committee, but the study cannot be activated on the GCRC until a copy of the IRB letter of approval is received at the GCRC office.
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This Site Last Updated Monday, January 29, 2001 |
Contact our Web Administrator with comments or questions regarding this site.
Copyright 1999-2004 University of Utah Health Sciences Center Huntsman General Clinical Research Center (GCRC) All Rights Reserved. |
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