Serious Adverse Events
Appropriate monitoring of study data is an extremely important component of all clinical trials. DSM requirements are dependent on the nature, size, and complexity of the trial. The CPHS will not serve as a DSM board for any trial.
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.
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How do I determine if an AE is reportable?
Please follow the definitions and apply them to the incident at hand.
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- Serious = Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
- Unexpected = Any adverse drug experience, the specificity or severity of which is not consistent with the current investigator brochure or consent form.