GCP-Related Laws, Regulations, Guidance, and Standard Operating Procedures

GCP-Related Laws, Regulations, Guidance, and Standard Operating Procedures

GCP-Related Laws, Regulations, Guidance, and Standard Operating Procedures

CRAs and CRCs must always work to ensure that the rights and the safety of human subjects remain uncompromised throughout the trial and that the integrity of the data collected is maintained. To help keep a site in compliance, a thorough working knowledge of good clinical practices is necessary.
Write a 2- to 3-page paper that analyzes 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).”
Additional Resources:
Comparison of FDA and HHS, Human Subject Protection Regulations
https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/EducationalMaterials/ucm112910.htm

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