Zdrowie i gospodarka · 20/11/2012

Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Electronic Source Data in Clinical Investigations." This document revises and updates the draft guidance entitled "Electronic Source Documentation in Clinical Investigations." This revised draft document provides guidance to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA- regulated clinical investigations. The revised draft guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data.