Reporting Timeliness Assessment

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Serious vs Non-Serious Adverse Events: Commonly Confusing Scenarios

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Blog post Serious vs Non-Serious Adverse Events: Commonly Confusing Scenarios                                       In the realm of clinical trials and pharmacovigilance, correctly classifying adverse events (AEs) as serious or non-serious is crucial for patient safety, regulatory compliance, and efficient risk management. But in complex medical situations, the distinction between "serious" and "non-serious" can occasionally become hazy. Let's examine typical circumstances that lead to misunderstandings and explain how to appropriately evaluate them.    ICH E2A guidelines state that an adverse event is considered     significant if it causes any of the following: Death A scenario that could endanger life Hospitalization or hospitalization over an extended period of time Long-term, severe impairment or inability Birth deformity or congenital abnormali...
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MASTER LIST OF SOP’S : A central document or database that keeps track of every SOP in a company is called a Master List of SOPs (Standard Operating Procedures). Teams can use it as a quick-reference registry to access, track, and manage each SOP's lifespan.Lorem ipsum dolor sit IMPORTANCE: Regulatory Compliance  Ensures adherence to GxP (Good Clinical, Laboratory, ManufacturingPractices), FDA, EMA, ICH, ISO, or other regulatory standards. Audit Readiness  Auditors and inspectors often request a master SOP list to verify documentation, review procedures, and ensure consistent practices. Operational Efficiency  Helps team members find the correct procedures quickly, reducing errors and training gaps. Version Control  Avoids confusion by ensuring teams work with the most up-to-date and approved version of a procedure. COMPONENTS: Field Description SOP Number Unique identifier(SOP-001) Title Descriptive title of procedure Department Functional area responsible...
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