Protocol Analysis Responsibilities -- General Clinical Research Center -- University of Miami School of Medicine

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General Advisory Committee
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Protocol Analysis Responsibilities

The Advisory Committee is responsible for review, approval, and oversight of all research projects requesting GCRC support. The chairman of the committee is Neil Schneiderman, Ph.D. The committee meets at least bi-monthly to evaluate and prioritize proposals based upon scientific merit and need for center resources. 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.

The GCRC chairperson and or program director assigns a primary and secondary reviewer to each protocol submitted. The reviewer critiques the study in a written report on the proposed science, suitability of study design, strengths and weaknesses, and need for center resources. The reviewer speaks about the project at the next GAC meeting when a vote will be taken as part of the minutes.

If the committee approves the protocol with no changes and if full IRB approval has also been obtained, the investigator can begin to use GCRC resources as soon as the GCRC staff has been in-serviced and trained by the principal investigator and/or their representatives.

If the study is not approved by the GAC as submitted, the protocol will be returned to the investigator with specific revision suggestions from the program director and or the GAC chair. Consideration following re-submission is usually expedited.

After each GAC meeting, the principal investigator of each study reviewed are sent a written notice from the GAC chair, the program director, and/or the GCRC administrator indicating the action taken by the committee at the meeting.

NOTE: No studies requiring center support can take place without General Advisory Committee approval, except when temporary approval is given by the chairman for urgent studies created by an unexpected opportunity to study unusual patients.

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