NIH and FDA launch gene research system

The National Institutes of Health and the Food and Drug Administration have booted up the Genetic Modification Clinical Research Information System, an online database on human gene transfer research.

The database, GeMCRIS, allows the reporting and analysis of adverse events in gene therapy trials.

'GeMCRIS will help advance gene therapy, while allowing NIH, FDA and the research community to maintain appropriate oversight,' NIH's director, Dr. Elias Zerhouni said.

Through drop-down menus and preformatted reports, users can navigate the GeMCRIS site to view information on particular characteristics of clinical gene transfer trials. For example, users can learn where trials are taking place and which diseases or health conditions are being studied. At the same time, GeMCRIS protects patient privacy and confidential commercial information.

Investigators and sponsors conducting human gene transfer trials can detail adverse events using a secure electronic interface on the GeMCRIS system and submit the reports instantaneously to NIH. Investigators and sponsors can save their NIH submission on their own computers and send copies to FDA as required by federal regulations.

About the Author

Mary Mosquera is a reporter for Federal Computer Week.

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