Biomedical Engineering Reference
In-Depth Information
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manufacturing, packaging, labeling, coding investigational product
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supplying and handling of investigational product
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access to records and clinical trial source documents
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safety information
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adverse event reporting
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monitoring of the clinical trial
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selection and qualification of monitors
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monitoring procedures, responsibilities and reporting
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audit of clinical trial sites and data
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clinical trial/study reports
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Clinical trial protocol
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clinical trial objective
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clinical trial design
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selection and withdrawal of subjects
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treatment of subjects
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assessment of efficacy
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assessment of safety
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statistical analysis plan
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quality control and quality assurances
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ethics
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financing and insurance
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publication policy
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supplemental information
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Investigational brochure is a computation of the clinical and non-clinical data on
the investigational product relative to the study of the product in human subjects
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introduction to the investigational product and clinical trial
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physical, chemical and pharmaceutical properties and formulation
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non-clinical studies
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effects in humans
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clinical trial data
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safety and efficacy
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publications.
7.7.2
Clinical trial design
A well designed clinical trial on a biomaterial intended for the treatment of skin
loss is critically important to evaluate the safety and effectiveness of the product
and support the regulatory approval of the product. It is also important to provide
objective clinical evidence of the clinical utility of the product and its safe use by
clinicians.
In a highly regulated environment, the clinical trial design should include data
important to support reimbursement of the product. Reimbursement agencies in
