It is a serious and unexpected event occurring at the PI's site.

Serious is defined by being:

• Fatal
• Associated with congenital anomaly
• Life-threatening
• Resulting in or prolonging hospitalization
• Associated with cancer
• Permanently or significantly disabling
• Requires medical treatment to prevent one of the other outcomes listed

Unexpected is defined as the event being inconsistent with the frequency, nature, or severity of the event as documented in the consent form or current investigator brochure and is not considered to be a known risk or complication of the illness under study.

The report of a serious adverse event or injury is to be reported to The CPHS using the Adverse Event (AE) Form. This form shall be sent to the CPHS office with a full description of the AE, or it may accompany a report from another site. Each question on the form must be answered, and the PI must sign the form.

Submission Deadline: Prompt reporting is expected for all SAE's. An e-mail/fax report is acceptable upon initial CPHS notification followed shortly thereafter with a completed form signed by the PI which may include further details (hospital report/discharge summary etc).

Submission Requirements: A completed and signed AE Form and any relevant information

Sample Forms & Documents: All necessary documents with instructions can be downloaded from the www.irbnet.org in the "State of New Hampshire DHHS CPHS, Manchester, NH" Library.

Frequently Asked Questions: