SafetyGlossary Term
ICH E2A Section III
The regulatory requirement to report certain serious safety findings to health authorities and ethics committees within specified short timeframes, typically within seven to fifteen calendar days of becoming aware of the event.
Expedited reporting requirements ensure that significant safety information is communicated rapidly to regulatory authorities, ethics committees, and investigators, enabling timely evaluation and action to protect trial participants and the public. These requirements apply to specific categories of serious adverse events and adverse drug reactions that are most important for ongoing safety assessment, particularly suspected unexpected serious adverse reactions and other serious safety findings that might alter the benefit-risk assessment of the investigational product.
Regulatory frameworks specify the events that require expedited reporting and the timelines for submission. For fatal or life-threatening SUSARs, notification to regulatory authorities is typically required within seven calendar days of the sponsor becoming aware of the case, with a complete report to follow within eight additional days. Other SUSARs generally require reporting within fifteen calendar days. These timelines are strictly enforced, and sponsors must maintain systems capable of identifying qualifying events, preparing required information, and submitting reports within the specified periods regardless of when during the week or year the event is identified.
Beyond regulatory submissions, sponsors must also ensure that investigators and ethics committees receive timely safety information relevant to their trials and participants. Investigator notifications enable prompt assessment of whether enrolled participants may be affected and whether informed consent processes require updating. Ethics committee notifications fulfill regulatory obligations and allow these bodies to reconsider their approval in light of new safety information. The sponsor's pharmacovigilance procedures must define clear processes for identifying, evaluating, and reporting events requiring expedited notification.
Seven-day reporting
"When the fatal cardiac event was determined to be a SUSAR, the sponsor submitted the initial seven-day expedited report to all relevant regulatory authorities within the required timeframe, with a commitment to provide the complete report within fifteen days of initial awareness."
Investigator notification
"Following expedited reporting of a SUSAR to regulatory authorities, the sponsor notified all investigators conducting trials with the investigational product within 24 hours, providing a summary of the event and any recommended actions."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.
ICH E2A Section III
The regulatory requirement to report certain serious safety findings to health authorities and ethics committees within specified short timeframes, typically within seven to fifteen calendar days of becoming aware of the event.
Expedited reporting requirements ensure that significant safety information is communicated rapidly to regulatory authorities, ethics committees, and investigators, enabling timely evaluation and action to protect trial participants and the public. These requirements apply to specific categories of serious adverse events and adverse drug reactions that are most important for ongoing safety assessment, particularly suspected unexpected serious adverse reactions and other serious safety findings that might alter the benefit-risk assessment of the investigational product.
Regulatory frameworks specify the events that require expedited reporting and the timelines for submission. For fatal or life-threatening SUSARs, notification to regulatory authorities is typically required within seven calendar days of the sponsor becoming aware of the case, with a complete report to follow within eight additional days. Other SUSARs generally require reporting within fifteen calendar days. These timelines are strictly enforced, and sponsors must maintain systems capable of identifying qualifying events, preparing required information, and submitting reports within the specified periods regardless of when during the week or year the event is identified.
Beyond regulatory submissions, sponsors must also ensure that investigators and ethics committees receive timely safety information relevant to their trials and participants. Investigator notifications enable prompt assessment of whether enrolled participants may be affected and whether informed consent processes require updating. Ethics committee notifications fulfill regulatory obligations and allow these bodies to reconsider their approval in light of new safety information. The sponsor's pharmacovigilance procedures must define clear processes for identifying, evaluating, and reporting events requiring expedited notification.
Seven-day reporting
"When the fatal cardiac event was determined to be a SUSAR, the sponsor submitted the initial seven-day expedited report to all relevant regulatory authorities within the required timeframe, with a commitment to provide the complete report within fifteen days of initial awareness."
Investigator notification
"Following expedited reporting of a SUSAR to regulatory authorities, the sponsor notified all investigators conducting trials with the investigational product within 24 hours, providing a summary of the event and any recommended actions."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.