Reference:ICH ICH E2A Guideline 1994 III B. - III C.

Document information
Reference	ICH ICH E2A Guideline 1994
Validity area	ICH
Scope(s)	G
Document name	ICH E2A Guideline
Version / Revision	1994
Status	Current
Document type	International guideline
Language(s)	EN
Description	CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING E2A
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 5 — Unit 5.3.1
Scope	G
Document part	III B. - III C.
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Expedited reporting, Reporting timeline, Adverse reaction, Unexpected SAR, Sponsor

Content

CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING

III. STANDARDS FOR EXPEDITED REPORTING B. Reporting Time Frames 1. Fatal or Life-Threatening Unexpected ADRs Certain ADRs may be sufficiently alarming so as to require very rapid notification to regulators in countries where the medicinal product or indication, formulation, or population for the medicinal product are still not approved for marketing, because such reports may lead to consideration of suspension of, or other limitations to, a clinical investigations program. Fatal or life-threatening, unexpected ADRs occurring in clinical investigations qualify for very rapid reporting. Regulatory agencies should be notified (e.g., by telephone, facsimile transmission, or in writing) as soon as possible but no later than 7 calendar days after first knowledge by the sponsor that a case qualifies, followed by as complete a report as possible within 8 additional calendar days. This report must include an assessment of the importance and implication of the findings, including relevant previous experience with the same or similar medicinal products.

2. All Other Serious, Unexpected ADRs Serious, unexpected reactions (ADRs) that are not fatal or life-threatening must be filed as soon as possible but no later than 15 calendar days after first knowledge by the sponsor that the case meets the minimum criteria for expedited reporting.

3. Minimum criteria for reporting Information for final description and evaluation of a case report may not be available within the required time frames for reporting outlined above. Nevertheless, for regulatory purposes, initial reports should be submitted within the prescribed time as long as the following minimum criteria are met: an identifiable patient; a suspect medicinal product; an identifiable reporting source; and an event or outcome that can be identified as serious and unexpected, and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. Follow-up information should be actively sought and submitted as it becomes available.

C. How to Report The CIOMS-I form has been a widely accepted standard for expedited adverse event reporting. However, no matter what the form or format used, it is important that certain basic information/data elements, when available, be included with any expedited report, whether in a tabular or narrative presentation. The listing in Attachment 1 addresses those data elements regarded as desirable; if all are not available at the time of expedited reporting, efforts should be made to obtain them. (See section III.B.) All reports must be sent to those regulators or other official parties requiring them (as appropriate for the local situation) in countries where the drug is under development.