Stark NJ, Adverse Event NotePad and MousePad, Clinical Device Group Inc, Chicago, IL 2008. Heavy writing paper for mouse control. $8.50 USD.
I designed the Adverse Event pad when I recalled sitting in team meetings at my former employer, The Marketing Department—who always seemed to know more about my clinical investigations than I did—would ask if a specific occurrence was reportable or not. Taking the time to use a reference tool allowed me to stall for a few seconds while I thought through the problem, and helped me keep myself out of trouble by spontaneously incorrect answers. There is room for a few notes on each page so you can title and date the meeting and keep notes for your files.
Definitions of Subject-Reported or Investigator-Observed Occurrences
[1] AE:The observation is an unwanted medical occurrence and is thus is initially an adverse event . A wanted medical occurrence is not adverse.
[2] The unwanted medical occurrence is device related and is therefore an adverse effect, but it occurred in a non-subject such as the investigator, a caregiver or a bystander. These observations are New Information or Near Incidents and may be reportable.
[3] ADE: The unwanted medical occurrence is related to the investigational medical device, be it device failure, inadequate instructions-for-use, or investigator error, the occurrence is an adverse device effect. "Effects" are related to investigational devices (as in cause and effect), while "events" are related to investigational drugs or biologics.
[4] SADE: The device related adverse effect meets the requirements of serious, such as hospitalization, and is a serious adverse device effect .
[5] SAE: The serious unwanted medical occurrence is not related to the investigational medical device, hence it is merely a serious adverse event.
[6]
ASADE: The serious unwanted medical device effect was anticipated, i.e., it was identified in nature, severity, and frequency of incidence in the risk assessment of the protocol and the informed consent.
[7] USADE: The serious unwanted medical device effect was not previously anticipated in the protocol's risk assessment and the informed consent. These effects are known as unanticipated serious adverse device effects.
[8] Trial Termination: Both US and EU regulations require termination of an investigation if the risk to subjects is unreasonable.
[9] Reporting: Reporting requirements depend on the protocol. Some protocols are written such that inevitable adverse events, say a scar following surgery, need not be reported.