Note for guidance on clinical safety data management: definitions and standards for expedited reporting
The Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95) is an internationally accepted standard for the reporting of important clinical safety information principally arising during clinical development of medicines.
The TGA has adopted the Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting in principle, particularly its definitions and reporting time frames. However, there are some elements of CPMP/ICH/377/95 which have not been adopted by the TGA and other elements which require explanation in terms of 'local regulatory requirements'.
- Introductory comments of the TGA
- 1. Introduction
- 2. Definitions and terminology associated with clinical safety experience
- 3. Standards for expedited reporting
- Attachment 1 - Key data elements for inclusion in expedited reports of serious adverse drug reactions