September deadline for global clinical investigations posted
This article was originally published in Clinica
Study Group 5 of the Global Harmonization Task Force has posted on its website a new proposed document, SG5(PD)N37, concerning clinical investigations. The deadline for comments is September 14 2008. The text is accompanied by a comment template. The document covers issues including: general principles when considering the need for a clinical investigation; general principles of clinical investigation design; and ethical considerations for clinical investigations. It is 11 pages long and only applies to clinical investigations of medical devices, and not diagnostics. Some aspects of this document may apply to studies conducted following commercial release of a device. Future GHTF documents will specifically address post-market follow-up studies.