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hello and welcome back to the gcp mindset Channel today well talk about the basics of essential documents in The Trial Master file before the clinical phase more after the intro welcome to the gcp mindset Channel and all topics on Clinical Research in this video we will provide you with a comprehensive overview of the key documents that are crucial for evaluating the conduct of a clinical study and ensuring data quality assurance essential documents play a vital role in the successful management of clinical trials and are instrumental in demonstrating adherence to good clinical practice standards and other regulatory requirements these documents are not only audited by sponsors independent audit functions but are also inspected by regulatory authorities to verify the validity of trial conduct and data Integrity the European medicines agency defines essential documents as those documents that individually and collectively allow for the evaluation of trial conduct and data quality these