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What Is a Clinical Safety Report?

A clinical safety report is given following the clinical study of pharmaceutical drugs or treatment. A clinical safety report contains the description, presentation and analyses of the study. Figures and tables are included to emphasize the findings. A clinical safety report is used to approve or deny the use of a drug or treatment. The report is issued by a pharmaceutical company testing a drug or treatment to the U.S. Food & Drug Administration for approval.

  1. Identification

    • A clinical safety report contains a description of how the features of the study were chosen and information on how the study was carried out. The report also contains a complete safety report including adverse effects on the patients and any abnormalities that appear. Demographic information for the patients involved in the study is included and subgroups are defined if the study is large enough. Data incorporated into tables or figures is presented at varying levels of detail, both in summary form and specifically.

    Terminology

    • Clinical safety reports contain some basic terminology that is not specific to a certain drug or treatment. Some of these terms are "adverse event," "adverse reaction" and "unexpected adverse reaction." An adverse event is a negative occurrence that happens in a study that is not necessarily connected to the study. An adverse reaction is a negative response from a patient to a drug related to its dosage. An unexpected adverse reaction is a reaction that is inconsistent with information available on the product.

    Standards

    • There are basic standards concerning what should be reported more quickly and the time frame of the report. Results that should be reported include unexpected adverse reactions, especially those that are serious. Other incidents that should be reported include an increase in the rate of a negative drug reaction, a potential hazard to the patients involved in the study, and a significant finding from an animal study. Life-threatening reactions should be reported as soon as possible and no later than seven days after the reaction was noticed. Non-life threatening reactions should be reported no later than 15 days after the reaction.

    Quality

    • Guidelines for the quality of a clinical safety report include the accurate recording, handling and storage of information obtained for the report and the confidentiality of the information gained in the study to be used for the report. A board of ethics committee maintains the integrity and quality of clinical studies and their safety reporting.

    Considerations

    • Considerations related to clinical studies and the reports derived from them include conducting the study in accordance with regulations and analyzing the data obtained from the study appropriately. When the data is analyzed, the method of the study should be considered and the report created accordingly and safety data should be catalogued and adequately reported.

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