SafetyGlossary Term
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.
The CIOMS form provides an internationally accepted format for expedited reporting of individual case safety reports from clinical trials, ensuring that essential information about suspected adverse drug reactions is communicated consistently and comprehensively to regulatory authorities. Developed collaboratively by CIOMS and the World Health Organization, this standardized template has been adopted by regulatory agencies worldwide and forms the basis for electronic safety reporting formats such as the ICH E2B specification.
The CIOMS I form captures key information in a structured, single-page format designed for rapid review. Fields include patient demographics and relevant medical history, details of the suspected drug including dosage and dates of administration, information about concomitant medications, a description of the adverse reaction including onset date, duration, and outcome, relevant laboratory data, the reporter's assessment of causality, and any actions taken such as drug withdrawal or rechallenge. This comprehensive but concise format enables regulatory reviewers to quickly assess the significance of individual reports.
While the paper CIOMS form has largely been superseded by electronic reporting through systems implementing the ICH E2B standards, the conceptual framework and data elements it established continue to underpin modern pharmacovigilance data exchange. Understanding the CIOMS format remains valuable for clinical research professionals, as it illustrates the minimum essential information required to characterize an adverse drug reaction and supports appropriate safety reporting. Many organizations continue to use CIOMS-formatted outputs as internal documents for safety case review even when electronic submission formats are used for regulatory reporting.
Regulatory submission
"Following identification of a SUSAR, the sponsor's pharmacovigilance team completed the CIOMS form with all required information and submitted it to the relevant regulatory authorities within the seven-day reporting timeline for life-threatening events."
Internal safety review
"The Safety Review Committee used CIOMS-formatted case narratives to facilitate systematic review of all serious adverse events reported during the monthly safety meeting, ensuring consistent presentation of key information."
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 specific situation or condition in which a drug, procedure, or treatment should not be used because it may be harmful to the patient.
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.
The CIOMS form provides an internationally accepted format for expedited reporting of individual case safety reports from clinical trials, ensuring that essential information about suspected adverse drug reactions is communicated consistently and comprehensively to regulatory authorities. Developed collaboratively by CIOMS and the World Health Organization, this standardized template has been adopted by regulatory agencies worldwide and forms the basis for electronic safety reporting formats such as the ICH E2B specification.
The CIOMS I form captures key information in a structured, single-page format designed for rapid review. Fields include patient demographics and relevant medical history, details of the suspected drug including dosage and dates of administration, information about concomitant medications, a description of the adverse reaction including onset date, duration, and outcome, relevant laboratory data, the reporter's assessment of causality, and any actions taken such as drug withdrawal or rechallenge. This comprehensive but concise format enables regulatory reviewers to quickly assess the significance of individual reports.
While the paper CIOMS form has largely been superseded by electronic reporting through systems implementing the ICH E2B standards, the conceptual framework and data elements it established continue to underpin modern pharmacovigilance data exchange. Understanding the CIOMS format remains valuable for clinical research professionals, as it illustrates the minimum essential information required to characterize an adverse drug reaction and supports appropriate safety reporting. Many organizations continue to use CIOMS-formatted outputs as internal documents for safety case review even when electronic submission formats are used for regulatory reporting.
Regulatory submission
"Following identification of a SUSAR, the sponsor's pharmacovigilance team completed the CIOMS form with all required information and submitted it to the relevant regulatory authorities within the seven-day reporting timeline for life-threatening events."
Internal safety review
"The Safety Review Committee used CIOMS-formatted case narratives to facilitate systematic review of all serious adverse events reported during the monthly safety meeting, ensuring consistent presentation of key information."
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 specific situation or condition in which a drug, procedure, or treatment should not be used because it may be harmful to the patient.