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Detection and Reporting of Adverse Events in Clinical Trials
When conducting investigative drugs testing, there are possible unwanted effects that may some into the process, some expected yet others unexpected. These unwanted effects are referred to as adverse events and they are often classified in terms of the levels of severity, the expectedness and relatedness.
In the severity classification, there is the mild adverse event where there are signs and symptoms that are undesirable but can be easily taken or tolerated by the subject, for instance irritation that does not change the operations of the subject. Such events do not require any therapy since the signs and symptoms are transient. At the moderate event there is low level of inconvenience caused to the subject and the daily activities may be interfered with but all these can be sorted out through a simple therapy. At the severe level of adverse events, the unwanted effects are seen to significantly interfere with the daily operations of the subject and need systematic drug therapy or any other suitable treatment. Such events are incapacitating. The serious adverse events are also often put under this categorization and it is when the investigator or the sponsor feels the event may result to death, is life-threatening...
The unexpected adverse events are those that are inconsistent with the data or information on the investigation being carried out. Such conditions are often not in the consent form, not in the intervention process outlined, nor in the product insert.
When it comes to the relatedness classification, the event can be categorized as definitely related, which means it has direct link with the agent administered in the course of the investigations. Possibly related classification is when the adverse events have a reasonable relation to the agents administered in the test but the reaction could be possibly result from another known process. Not related level means the adverse event is clearly and definitely not elated to the event (University of California, 2014).
In the lifetime of the investigative test, the occurrence of the adverse events need to be closely followed and handled appropriately and notification of the relevant bodies be done. In the event of unexpected life threatening adverse event that is…
References
US Department of Health and Human Services, (2007). Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events. Retrieved August 8, 2015 from http://www.hhs.gov/ohrp/policy/advevntguid.html
University of California, (2014). Adverse Events in Clinical Trials: Definitions and Documentation. Retrieved August 8, 2015 from http://hub.ucsf.edu/sites/hub.ucsf.edu/files/6.%20Adverse%20Eventsd%20Definitions.pdf
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