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This standard operating procedure (SOP) outlines the process for preparing and submitting Development Safety Update Reports (DSURs) for clinical trials sponsored by King\'s Health Partners Organizations or managed by the King’s Health Partners Clinical Trials Office (KHP-CTO). It establishes guidelines for periodic reporting on drugs under development, including safety evaluations and updates to regulatory authorities and Research Ethics Committees (RECs).
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Preparation and submission refers to the process of gathering, organizing, and officially presenting necessary documents or reports, typically for regulatory or compliance purposes.
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Entities or individuals subject to specific regulations, such as businesses, taxpayers, or institutions, are required to file preparation and submission of relevant documents as mandated by governing authorities.
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The purpose is to ensure compliance with laws and regulations, provide necessary information to authorities, and to maintain transparency and accountability in reporting.
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Typically, information that must be reported includes identification details, financial data, relevant transactions, and other data specific to the requirements of the submission.
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