An adverse event can be described as any untoward or unfavorable medical occurrence in a clinical investigation subject. Mostly, it occurs when a clinical officer administers pharmaceutical product that have no casual relationship with the treatment. It results to abnormal signs in the laboratory findings, symptoms, and disease that cause physical and psychological harm. There are different types of adverse event that can occur during a clinical trial that are portrayed in various conditions. Whenever the researcher notices any sign of an adverse event, he/she should consider reporting. The urgency of reporting an adverse trial after detection varies with the type. It is therefore, important to explain different types of adverse event, the conditions related to it, and how fast it should be reported after detection.
Types of adverse event
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Serious adverse event
It is characterized by life-threatening where the subject is at risk of death. Again, when the subject is hospitalized or there is prolongation of hospitalization after the drug is administered. Incapacity in congenital incongruity, birth defect or any other disability that occur due to the effect pharmaceutical reaction is also considered as a serious adverse event. Example of such condition include; internal bleeding and hemorrhaging with an abrupt drop in blood pressure resulting to unconsciousness (Morgan et al, 2010). When a serious adverse event is detected, the researcher should report immediately to the principal investigator or the sponsor. The maximum time should be 72 hours after detection.
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Non-serious adverse event
These are adverse events that are not life threatening. These adverse events do not have any serious implication of the patient health and are easily managed without hospitalization or surgery. The events do not expose the victim to serious life conditions. They are characterized by nausea, dizziness, loss of appetite, and body weakness. The researcher should report if the symptoms continue after 7 days.
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Serious unsuspected adverse event
It is an essential medical event that may not cause death to the victim, but is life threatening. It occurs when the patient’s condition is jeopardized after medication. The condition demands the patient to receive further medication or to undergo a surgery (Morgan et al, 2010). Example of such condition are; allergic bronchospasm that require intensive treatment in an emergency room, blood dyscrasias, the patient developing drug dependency, and convulsions. It should be reported within 72 hours after detection.
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Serious unexpected suspected drug reaction
This is a serious adverse event with some degree of probability that the cause is a reaction of administered drug where the reaction is unexpected. The adverse event in this case is only caused by drugs. Sometime the patient may not show the reaction immediately. It is characterized hemorrhaging with an abrupt dropped blood pressure, unconsciousness, and convulsions (Morgan et al, 2010). The condition can occur between 7 and 8 days. The researcher should report immediately after detection of the symptoms (within 72 hours). The team must start an initial or full report within 7 days of after the occurrence of unexpected drug reaction. If there is a need of a follow-up report, it should be conducted within 8 days after the initial report.
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Unanticipated serious adverse device event
This adverse event in this case happens when the degree of probability relate to the effect of a medical device. The device is supposed to help the patient in the normal functionality, but cause serious reaction to the health. The reaction also varies with individuals. Unanticipated serious adverse event mostly affect the nervous system. The researcher should report immediately after the detection.
In conclusion, adverse event is an untoward medical reaction to pharmaceutical clinical investigation subject. Some events can cause death, disability, and genital incongruity. The condition of the adverse event include internal bleeding and hemorrhaging with an abrupt drop in blood pressure resulting to unconsciousness, allergic bronchospasm, blood dyscrasias, drug dependency, and convulsions in severe case. The adverse event should be reported with 72 hours after detection. The researcher, sponsors, and regulatory authority should ensure due care to minimizes the case of adverse event.
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