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Reporting Safety Questions
How do I report a Serious Adverse Event (SAE)? expand_more
o Serious adverse events should be reported to Lilly using the sponsor-investigator institutions SAE form – any form is acceptable to submit. For Investigator Initiated Clinical Research Trials, Lilly must be notified within 15 days of you receiving notification of any “serious” adverse event that is possibly related to the Lilly drug, based on your assessment, experienced by a patient participating in the Study and receiving a Lilly drug.
o This process is used to submit Serious Adverse Events (SAEs) to Lilly. Note: this is only intended to be used for adverse events, it is not to be used for product complaints, etc. Click on the “Report SAE” button. The site must provide the Site & Patient Number you are reporting the SAE on. Attach your SAE report (you may also add additional information in the free text field). Click the Submit button. You will receive an email notification (within 3-5 minutes) informing you the SAE was successfully reported.
How do I report a product complaint? expand_more
Your local Lilly representative will provide the product complaint form and instructions.