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Seven steps for statistical success in clinical trials [Good clinical practice guidelines] Webinar Part 2
ACTA STInG in collaboration with Cytel, invite you to come on a whirlwind tour of the current and developing statistical guidelines for clinical trials, all distilled into seven steps. This is an opportunity to be introduced, refreshed or updated on the statistical aspects of GCP in two 1 hour seminars. ICH-GCP guidelines are used in clinical trials around the globe with the main aim of protecting and preserving human rights, which is relevant for both investigator-led and industry sponsored trials. They are an international ethical and scientific quality standard; for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.
STEPS 6-7: Understanding statistical aspects of additional regulatory (EMA, FDA, PDMA, CDE & TGA) requirements for clinical trials and what to expect in ICH E20 (Adaptive Designs, anticipated in 2021).