Documenting Adverse Events

Abstract:

Compliance with Good Clinical Practice (GCP) on safety data is important for the knowledge of the toxicity profile of a product. All adverse events (AEs) including abnormal laboratory findings should be documented, sorted, and analyzed to ensure the protection of patients. The main objective of this work was to identify and classify the hematological and blood chemistry data not documented as AEs in sponsor's adverse event and clinical laboratory databases of five clinical trials. From 458 screened laboratory parameters, 450 were unidentified as AEs and eight of them were documented as AEs in the adverse event database. The abnormal clinical laboratory parameters found in these databases were identified and classified as AEs, using the table of toxicity indicated in each protocol. Most of the events were found mild and moderate; while only three of them were life threatening. The most frequent AEs were anemia and increased levels of alkaline phosphatase. These results show that there are deficiencies in the recognition and classification of data as AEs by clinical investigators, causing underreporting in safety data.

Año de publicación:

2010

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Fuente:

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