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...
Accounting and Intrusion Detection In a report issued by Paladin Technologies, Inc., entitled: "Security Metrics: Providing Cost Justification for Security Projects," 273 organizations were surveyed on the topic of security. The report illustrates in quantifiable terms the depth and reach of intrusion detection on the financial viability of the organization. The combined reported losses from the firms surveyed totaled $265.6 million in 1999. The highest loss categories were reported as follows: Type
Sarbanes-Oxley Act of 2002 in reducing fraudulent financial reporting Introduction to Fraudulent Financial Reporting Available research on financial statement fraud relies mostly on anecdotal evidence (for example, Wells, 2001, 2002, 2004a, and 2004b; Rezaee, 2003). This evidence offers advice on how mechanisms related to the fraud triangle can be curtailed. It leads to theoretical sense to reduce factors which lead to more instances of fraud. However, deterrence and established deterrence methods
Stated to be barriers in the current environment and responsible for the reporting that is inadequate in relation to medical errors are: Lack of a common understanding about errors among health care professionals Physicians generally think of errors as individual that resulted from patient morbidity or mortality. Physicians report errors in medical records that have in turn been ignored by researchers. Interestingly errors in medication occur in almost 1 of every 5 doses
Consultant Pharmacists Impact on the Treatment of Hypercholesterolemia What is Cholesterol, and Why is it of Concern? Guidelines for Treating Hypercholesterolemia Management of Hypercholesterolemia Management of Hypercholesterolemia By Different Health Care Workers. Practical Management of Hypercholesterolemia Community Pharmacists and the Management of Hypercholesterolemia Economic Impact of Pharmacists' Treatment of Hypercholesterolemia This paper will look at the impact of consultant pharmacists on the treatment of hypercholesterolemia by physicians. Pharmacists have now assumed responsibilities outside the dispensing counter and have
5% while 70.5% took Aspirin within six hours after reaching hospital and 76.5% of patients admitted in the NICVD were receiving Aspirin therapy." (Jaiwa, 2006, p.1) Jaiwa reports a more recent study that states findings that out of 52 patients with chest pain only 13 patients or 25% of the 52 received aspirin. The stated reason for not giving aspirin to the other 39 patients included that "chest pain was not
Root Cause Analysis PolicyPOLICYIn the furtherance of achieving the goal of improvement in patient safety and its quality, it is the policy of Pikeville Medical Center (PMC) to make use of the Patient Safety Evaluation System (PSES) to collect, analyze, and submitting information about patient safety events to a Patient Safety Organization (PSO). The specific patient safety event for addressing the sentinel event of discharge of an infant to the
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