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Periodic Reporting In Argus Safety

periodic-reporting-drug-safety

 

When it comes to periodic reporting, we feel that the generation and tracking of periodic reports in Oracle’s Argus Safety is far easier than in other safety and pharmacovigilance systems. In the system, periodic reports are all created and generated from a central screen within the application.

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The four basic kinds of periodic reports in Argus Safety share a very similar configuration interface that allow you to perform the following tasks:

  1. Set general information on the report
  2. Select the product being reported
  3. Select the cases required for inclusion in the period
  4. Identify AE of special interests
  5. Include user-defined line listings/tabulations
  6. Identify or manipulate the required summary tabulations
  7. Establish security
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In prior versions of Argus Safety (pre-7.0.2), periodic reports were submitted directly from the system, although it often caused performance issues while waiting for large periodic reports to complete. Post-7.0.2, periodic reports are submitted in the background, on the report server, thus mitigating the performance problems previously experienced. One of the benefits of the newer versions of Argus Safety is that there are no system performance issues when generating and submitting very large reports.

To read past posts in our Argus Safety features series, click here.

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Rodney Lemery

Dr. Rodney Lemery specializes in the implementation, support, and development of software used in the collection, management, and analysis of clinical data. His accomplishments as director of safety and pharmacovigilance at Perficient include the management of numerous clinical application implementation projects. In addition to his expertise in clinical and safety applications, Rodney is able to navigate between the technical and clinical worlds with ease due to his complementary educational background in epidemiology. He also holds a part-time professorship in the School of Health Sciences at Walden University, which solidifies his ability to lead global safety implementations at Perficient. Rodney has been with Perficient, via the acquisition of BioPharm Systems, since 2000. Prior to joining the company, he worked at Pfizer.

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