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PROTOCOL DEVELOPMENT
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Applicable? If yes, please identify responsible party.
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1.
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Research Design:
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___________________
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2.
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If drug, biological agent, or device is administered:
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Is the dose/route/indication FDA approved?
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Y / N
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If not, is there an IND, IDE?
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Y / N
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Who is the holder of the IND, IDE?
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___________________
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Who is the responsible party for the following:
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Manufacturing product following GMP?
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___________________
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Ensuring availability of adequate supply of product to conduct trial?
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___________________
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Packaging, labeling, and distribution?
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___________________
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Storage, usage, disposal, and accountability at clinical sites following GCP?
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___________________
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3. For procedures conducted during the study (e.g., cardiac catheterization, psychological profile), who is responsible for ensuring that:
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Procedures are standardized, well established, and clearly defined?
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___________________
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Individuals conducting procedure(s) are properly credentialed and/or trained?
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___________________
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