Development Core Safety Information (DCSI) constitutes a distinct segment within an Investigator’s Brochure (IB) that shares the same structural format as the Company Core Safety Information (CCSI). This section presents a summarized overview of all pertinent safety information, which is expounded upon more comprehensively in the main body of the IB.
The DCSI serves as the pivotal reference safety document that dictates the categorization of adverse drug reactions as either listed or unlisted, playing a fundamental role in ensuring accurate reporting and evaluation of safety concerns throughout the course of clinical development.
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