Human Research Protections Program
 

Human Research Protections Program

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Welcome to UCI IRB's Adverse Events and Unanticipated Problems Involving Risk to Participants or Others (AE/UP) Report.

Please follow these brief instructions to submit a report. Click here for more detailed instructions.

  1. Enter in your UCINetID and password.

    What is a UCINetID?
    In order to access the electronic Adverse Event and Unanticipated Problem (AE/UP) online form you must have a UCInetID and password, and be listed on the IRB-approved protocol. The UCInetID is a 3-to 8-letter code that is used to authorize you to gain access to UCI electronic services, such as the electronic AE/UP report form and the Continuing Protocol Application. Only the Lead Researcher and qualified Co-researchers can submit an electronic AE-UP report form to the IRB using his/her UCINetID, which serves as an "electronic signature."

    If you already have a UCINetID and password, please proceed to the next page by clicking the "Continue" button. Once you log in, you will be able to complete and submit your Adverse Event/ Unanticipated Problem report.

    If you do not have a UCINetID, or if you would just like more information about the UCINetID, please click here http://www.nacs.uci.edu/ucinetid/.

  2. Complete the online form, upload documents, as applicable and submit the form to the IRB.

    You will provide specific information about the event and determine whether changes to the IRB-approved documents (e.g., protocol narrative, consent form) are necessary. In addition, you will be asked to choose among several descriptions that best characterize the event, experience or outcome.

  3. Several terms within the online form are hyperlinked to the ORA Glossary. If you have additional questions visit our web pages: Reporting of Adverse events, Unanticipated Problems, and Violations or Frequently Asked Questions for additional information or call the HRP staff.
  4. Retain a hard copy of the submitted report for your study records.
  5. Your comments and suggestions about improving this system are important to us. Please direct them to Karen Allen at 949-824-1558 or by email.
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