federal_register: 2011-73

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2011-73 Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Electronic Source Documentation in Clinical Investigations." This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It also describes FDA's recommended procedures for ensuring the reliability, quality, integrity, and traceability of electronic source data and source records maintained at the site for FDA inspection. 2011-01-07 2011 1 https://www.federalregister.gov/documents/2011/01/07/2011-73/draft-guidance-for-industry-on-electronic-source-documentation-in-clinical-investigations https://www.govinfo.gov/content/pkg/FR-2011-01-07/pdf/2011-73.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Electronic Source Documentation in Clinical Investigations." This document provides guidance to sponsors, contract research organizations...  

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