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Clinical Trial Regulation Conference 56 December 2017 Millennium Hotel London Mayfair, London, UK OVERVIEW Program CHAIR Nick Sykes Senior Director, Worldwide Safety & Regulatory, Pfizer, United Kingdom

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What is clinical trial regulation?

Clinical trial regulation refers to the rules and guidelines that govern the conduct of clinical trials to ensure the safety and well-being of participants.

Who is required to file clinical trial regulation?

The sponsor or organization conducting the clinical trial is required to file the clinical trial regulation.

How to fill out clinical trial regulation?

Clinical trial regulation can be filled out by providing all the necessary information and documentation required by the regulatory authorities.

What is the purpose of clinical trial regulation?

The purpose of clinical trial regulation is to protect the rights and safety of participants, provide reliable data on the effectiveness and safety of new treatments, and ensure the quality and integrity of clinical trial data.

What information must be reported on clinical trial regulation?

Clinical trial regulation typically requires information such as study protocol, informed consent forms, adverse event reporting, and study outcomes.

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