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
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