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Zdrowie i gospodarka · 10.12.2001

Patient Profile Viewer; Notice of Pilot Project

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is seeking volunteers to participate in a pilot project involving the testing of the Patient Profile Viewer (PPV). The PPV is computer software that allows a reviewer to display data collected from case report tabulations (CRTs) submitted in electronic format. We are working with PPD Informatics to develop the PPV under a Cooperative Research and Development Agreement (CRADA) in an effort to improve review efficiency, develop standards for submission of data, and eliminate the need for the submission of patient profiles by applicants of new drug applications (NDAs). To help in this development, we are seeking volunteers to provide CRT datasets from clinical studies to test the PPV. Data supplied during the pilot project will not replace any regulatory requirements for submitting CRTs.

Source: Federal Register — Food and Drug AdministrationOpen original release →