FDA Final Electronic Source Data Guidance

FDA issued a FINAL”Guidance for Industry and Food and Drug Administration Staff – Electronic Source Data in Clinical Investigations” Spetember 2013. The full document is at the link provided. It discusses the value of electronic source data for clinical investigations as well as types of controls to ensure integrity and trace origin. AMong other requirements it states: “When data elements are transcribed from paper sources into an eCRF, the clinical investigator(s) must also retain the paper sources, or certified copies, for FDA review. Other records (electronic and paper) required to corroborate data in the eCRF (see section III.A.2.a) may also be requested by FDA during an inspection.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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