Biomedical Technology Assessment

Genetic Modification Clinical Research Information System (GeMCRIS)

The Genetic Modification Clinical Research Information System (GeMCRIS) is a web-based information system for human gene transfer trials that was developed in collaboration with the Food and Drug Administration (FDA) and is designed to facilitate safety reporting.  Investigator and sponsors of a human gene transfer trials can utilize this system to report serious adverse events (SAEs) and annual reports.  A hard copy of the electronic report can be printed and used to fulfill FDA reporting requirements.  GeMCRIS also allows members of the public to access basic reports about human gene transfer trials registered with the NIH and to search for information such as trial location, the names of investigators conducting trials, and the names of gene transfer products being studied.

 

  • Adverse Event Reporting Template
  • Important Tips for Using the GeMCRIS Page
  • GeMCRIS
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