What the New FDA Guidance for ICH GCP E6 R2 Means for Sponsors and CROs

FDA Guidance for Good Clinical Practice (GCP) is an international quality standard defined by the International Council for Harmonization (ICH) that governs ethical and scientific considerations for designing, conducting, recording and reporting trials involving human subjects. Compliance with FDA Guidance for GCP in clinical trials helps to assure that the rights, well-being and safety of trial participants are protected and that the data generated in the trial is credible.

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