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analyze the differences between GCP-related laws, regulations,
guidance, and SOPs. Explain how they reflect the influence of the
ICH “Guideline for Good Clinical Practice E6(R1).”

Evaluation Criteria Include:

Provide a clear and focused explanation of your response to the
issues raised here

Provide an understandable and realistic rationale for your view
of the impact of the laws and regulations

Is information from the textbooks and other sources integrated
into your analysis appropriately? You must provide complete
citations for all sources.

Is the paper professionally presented? It is important to
present your information as clearly and succinctly as possible. (Do
not sacrifice thoroughness for mere brevity.) Please proofread
carefully for grammar and spelling errors.

Support your assumptions by citing in APA format any reputable
source material used