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Office of Biotechnology Activities
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National Institutes of Health - Office of Science Policy
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| Using GeMCRIS for Adverse Event Reporting |
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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.
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For potential new users, the PI must submit a signed written request on their letterhead with their own email address and OBA protocol number(s). The body of the letter should include the title, direct mailing address, telephone number, and fax number for each user that should be granted GeMCRIS access. The PI should also indicate if the authority to report adverse events on the PI's behalf should be delegated to any of the potential GeMCRIS users.
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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.
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Questions or Feedback About GeMCRIS? |
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You may ask questions or provide feedback about GeMCRIS
by email to gemcris@od.nih.gov,
or by U.S. mail or fax using the contact information on our Contact Us page.
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