Human Research Review Committee
(HRRC-IRB)
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Protocol Definition and Requirements
Although a protocol may have the same information as the application, the protocol is a working document. In other words, it evolves as your study evolves.
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It is good clinical practice to keep the protocol updated as this is the official record of how your study should be conducted.
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When revisions occur during the course of the research you will need to submit a revised protocol as an amendment.
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Also, at continuing review a current protocol document is required.
A protocol is a formal design or specific plan for the research.
The protocol should include:
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Background information
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Rationale for performing the research
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Objectives or hypotheses
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Description of the research design
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Number of participants to be enrolled
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Length of study
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Methodology (schedule of testing, procedures, medications and dosages, etc.)
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Inclusion/Exclusion Criteria
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Statistical considerations that will be employed
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Safety Oversight
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Always include page numbers
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Each time a change is made - the version date should be changed!
The following document contains the basic outline that you should follow to develop your protocol. Protocol Guidelines.
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