tailieunhanh - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Planning is the most important part of running a successful event, and this means starting well in advance. The best way to approach planning is to develop a detailed management plan, which includes a timetable of what needs to be done and when. Crucial elements of the planning for the event, such as fundraising, booking performers and advertising need to happen well in advance of the date of your event so a timeline schedule is essential. Developing an Event Plan is critical to ensure your events success. The information provided in this document is designed to. | Common Terminology Criteria for Adverse Events CTCAE Publish Date August 9 2006 Quick Reference The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event AE reporting. A grading severity scale is provided for each AE term. Components and Organization CATEGORY A CATEGORY is a broad classification of AEs based on anatomy and or pathophysiology. Within each CATEGORY AEs are listed accompanied by their descriptions of severity Grade . Adverse Event Terms An AE is any unfavorable and unintended sign including an abnormal laboratory finding symptom or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. An AE is a term that is a unique representation of a specific event used for medical documentation and scientific analyses. Each AE term is mapped to a MedDRA term and code. AEs are listed alphabetically within CATEGORIES. Short AE Name The Short Name column is new and it is used to simplify documentation of AE names on Case Report Forms. Supra-ordinate Terms A supra-ordinate term is located within a CATEGORY and is a grouping term based on disease process signs symptoms or diagnosis. A supra-ordinate term is followed by the word Select and is accompanied by specific AEs that are all related to the supra-ordinate term. Supra-ordinate terms provide clustering and consistent representation of Grade for related AEs. Supra-ordinate terms are not AEs are not mapped to a MedDRA term and code cannot be graded and cannot be used for reporting. Remark A REMARK is a clarification of an AE. Also Consider An ALSO CONSIDER indicates additional AEs that are to be graded if they are clinically significant. Navigation Note A Navigation Note indicates the location of an AE term within the CTCAE document. It lists signs symptoms alphabetically and the CTCAE term will appear in the same category unless the .