FDA Guidance: Electronic Source Data in Clinical Investigations, 9/13

$0.00

In September, 2013, the FDA issued Guidance for Industry, Electronic Source Data in Clinical Investigations. This document provides recommendations to study sponsors, clinical research organization (CROs), data management centers, and clinical investigators.

This guidance recommends practices to help ensure the reliability, quality, integrity, and traceability of electronic source data. The guidance addresses identification and authorization of source data originators, audit trails, eCRFs, and responsibilities for data retention and reviews. It is intended to be used with FDA Guidance “Computerized Systems Used in Clinical Investigations.”

“Source Data” includes all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical investigation used for reconstructing and evaluating the clinical investigation.

Chapters of this Guidance address:

• III.A. Electronic Source Data Capture
• III.B. Electronic Source Data Review
• III.C. Retention of Records by Investigators
• III.D. Electronic Source Data Access