Adverse events electronic reports

Current computerized analyses of adverse events still typically consist of a vast number of discrete, often personal, ad hoc processes that mimic paper and pencil methods. Some commercial-off-the-shelf (COTS) software tools (e.g., Adobe Acrobat , Microsoft Word , Excel ) do have the capability to search for specihc terms in electronic documents/case reports and do have navigational tools with hyperlinks and fullfull-text indexing that enable researchers to create their own hyperlinks. Some other COTS software tools (e.g., SAS , Excel , Access , IMP ) allow importation of electronic case report tabulations (ECRT) for more detailed analysis. 

In postmarketing electronic longitudinal medical records, redundant and potentially contradictory information may come from several sources, (e.g., reports from medical residents, their supervisors, the attending physicians). In these cases time stamping of each event may help to delineate the important sequences in understanding the adverse events. 

Limited Knowledge of Exposure and Reporting Rates in Postmarketing Data. Unlike clinical trials and electronic medical records in clinical practice, postmarketing voluntarily reported data contain limited information about the total number of patients exposed and the duration of exposure. This problem is compounded by the fact that adverse events are often underreported [2,9]. 

FDA ESG This document provides an overview of the process of electronic submissions and provides registration and confirmation processes as well as links to electronic submission requirements of the Center for Biologies Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), the Adverse Events Reporting System (AERS), and the Center for Devices and Radiological Health (CDRH). 

Sample Electronic NDA Submission Postmarketing Adverse Events Reporting... 

There should also be an explanation and justification of the method by which the clinician s words, such as lethargy, severe pain, stupor, etc., are transformed into numbers that can be manipulated in statistical calculations. The coding of case report forms entering adverse event and concomitant medication information, whether done manually or electronically, is obviously necessary. This is easily done with the use of standard references, such as the COSTART and the WHO dictionaries. 

As clinical trial protocols increase in complexity, there is an industry-wide shift toward adoption of electronic solutions to improve critical functions, most notably the collection, handling, analysis and storing of clinical data and the reporting of adverse and serious adverse events. 

Information received through the MedWatch program is entered into the Adverse Event Reporting System (AERS) database. The AERS database is designed to permit electronic or paper submission of reports, comply with international standards and terminology, and facilitate pharmacovigilance screening. In addition to the... 

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