Transcription of KEY ELEMENTS OF A CLINICAL RESEARCH …
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KEY ELEMENTS OF A CLINICAL RESEARCH …
Key ELEMENTS of a CLINICAL RESEARCH Protocol9/2010 Compiled from NIH Guidelines and ICH/GCP Guidelines KEY ELEMENTS OF A CLINICAL RESEARCH protocol What is a CLINICAL RESEARCH protocol ? It is the formal design or plan of an experiment or RESEARCH activity. It is the plan submitted to an Institutional Review Board for review and to an agency for RESEARCH support. The protocol includes a description of the RESEARCH design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on collected data.
Key Elements of a Clinical Research Protocol9/2010 Compiled from NIH Guidelines and ICH/GCP Guidelines KEY ELEMENTS OF A CLINICAL RESEARCH PROTOCOL
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