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Zdrowie i gospodarka · 18.09.2013

Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Electronic Source Data in Clinical Investigations." This document provides guidance to sponsors, contract research organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. This guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.

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