Use of electronic health record data in clinical investigations - guidance for industry

About this guideline

Adopted by the TGA: 27 February 2023

Overseas publication date: July 2018

Categories: FDA | Procedural

TGA annotations:

The general principles of this guideline are adopted. Please note that any references to FDA processes are not applicable in submissions to the TGA.

• Where FDA guidelines adopted in Australia include references to US legislation, the requirements contained in the referenced US legislation are not applicable to the evaluation of medicines by the TGA.
• The pdf version of this document was downloaded and saved from the U.S. Food and Drug Administration (U.S. FDA) site on 1 May 2024.

For more information see International scientific guidelines adopted in Australia.