The Global Harmonization Task Force guidance on reporting AEs during pre-market clinical investigations
August 01 2011
The Global Harmonization Task Force have produced new guidance on reporting adverse events during pre-market clinical investigations of medical devices and is seeking stakeholder feedback. Comments will be accepted until 10 December this year.
The draft guidance is intended to supplement the exsisting regulatory requirements of countries participating in the GHTF, but may not currently reflect all regulatory requirements as some countries do differ.
The guidance explains the types of adverse events that should be reported by investigational device sponsors to national competent authorities. The GHTF among with a number of competent authorities believes that the reporting requirements for pre-clinical investigations should be more stringent than the post-market vigilance requirements because such medical devices may not have been used in humans.
The draft guidance is synonymous with the recently revised ISO 14155:2011 standard (Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practices), as most of the definitions in the draft guideline are referenced in the ISO 14155 standard.
The guidance states that in addition to informing the national competent authorities about all reportable adverse events, it is necessary for sponsors to report such events to ethics committees and all principle investigators.
The draft document suggests different timelines for reporting adverse events of various levels of severity. It also requires sponsors to report certain events to Investigators. The guideline also explains the content of adverse event reports, highlighting the mandatory information that sponsors should be providing.
To go direct to the GHTF website and download the guidance please click here http://www.ghtf.org/sg5/sg5-proposed.html