NIH, FDA launch information system on human gene transfer research

NIH, FDA launch information system on human gene transfer research

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have launched a new web-accessible database and information system on human gene transfer research that will help expedite institutions reporting of adverse events. The goal of the Genetic Modification Clinical Research Information System (GeMCRIS) is to improve the government's ability to monitor this type of research, while providing valuable information to the public on the characteristics of ongoing trials.

GeMCRIS provides investigators and sponsors conducting human gene transfer research with a secure, electronic interface for reporting adverse events immediately to NIH, and generates a paper record to be submitted to FDA in accordance with federal regulation. Both agencies emphasize that GeMCRIS will enable patients and the public to become better informed about human gene transfer research through its easy-to-use report format on a public website (www.gemcris.od.nih.gov). Investigators and sponsors who wish to use the system to report adverse events must first contact the GeMCRIS Systems Administrator (gemcris@od.nih.gov ).

Source: AAMC STAT, April 5, 2004