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.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.