Based on the definition of the European Medicines Agency (EMA), “Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any favourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. EMA divides adverse event (AE) reports into solicited and unsolicited (depending on their source). The critical fact is that there should be clear understanding when to expedite the AE reporting in trials you are involved with.
Using this flow chart (Expedited Adverse Event Reportability Assessment Chart), you will learn how to follow the thought process for decisions on the following:
- Whether an adverse event is subject to expedited reporting
List of Charts in This Job Aid
- Chart 1: Assessing Expedited Reportability of Adverse Events
Please note that in this Expedited Adverse Event Reportability Assessment Chart
- Simply suggest the general thought process to be followed based on the EMA regulations for reporting AES. The full text of applicable regulatory provisions should be considered in making final decisions in what AEs should be reported in your specific cases depending on the study, protocol, the country in which the study is being conducted and the regulatory body in charge.
- Does not address specific requirements that may be imposed by specific organizations, such as the Food and Drug Administration, National Institutes of Health, other sponsors, or state or local governments based on your specific product or specific inclusion or exclusion criteria defined.
Who Can Benefit From This Expedited Adverse Event Reportability Assessment Chart
- The contents are intended to assist the following groups in the process of recognizing the adverse events that need to be reported:
- Drug Safety Team
- Sponsor’s Project Team
- Medical Monitors
- Clinical Research associates
- ID: 1321
- SKU: JA-0002-RC
- Type: Job Aid
- Format: Downloadable PDF File
- Date of Last Update: Feb 15, 2017
- Price: $20.00
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