Using GeMCRIS for Adverse Event Reporting In order to become authorized to use GeMCRIS for adverse event reporting, investigators, study coordinators, and sponsors first will need to obtain a User ID and password.  Principal investigators (PIs) should verify the information for their trials on the GeMCRIS public information site, then send a signed, written request on institutional letterhead to OBA at the address below.  This request should indicate the PI's email address and the OBA number(s) for the human gene transfer protocol(s) with which he or she is associated.   Other potential users must submit a signed written request with their email address and OBA protocol number(s), but also include their title, direct mailing address, telephone number, and fax number.  This letter must be accompanied by a letter signed by the PI that delegates to the potential GeMCRIS user the authority to report adverse events on the PI's behalf.    In both cases, OBA will confirm eligibility to report adverse events and then send by U.S. mail a User ID and additional instructions for entering adverse events.  Questions or Feedback About GeMCRIS? You ask questions or provide feedback about GeMCRIS by email, U.S. mail, or fax using the contact information below:  NIH Office of Biotechnology Activities 6705 Rockledge Drive, Suite 750  Bethesda, MD  20892-7985* Phone: 301-496-9838 Fax: 301-496-9839 gemcris@od.nih.gov   Return to the general GeMCRIS information page Return to the Homepage of the NIH Office of Biotechnology Activities Return to the Homepage of the FDA Center for Biologics Evaluation and Research