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Serious Unexpected Adverse Reactions (SUSAR) reporting

Date: 2009-02-17 12:30:57 Member: Manoj Karwa Category: Educational Discipline: Clinical / Health / Medicine Link:

A-Indian regulations do not specifically refer to SUSARs. However, as per Schedule Y any unexpected serious adverse event (SAE) (as defined in GCP guidelines) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the Sponsor to the Licensing Authority and to the other Investigator(s) participating in the study (see Appendix XI)

Investigator(s) shall report all serious and unexpected adverse events to the Sponsor within 24 hours and to the Ethics Committee that accorded approval to the study protocol within 7 working days of their occurrence.

Most of the companies follow international reporting timelines as per ICH.
ICH Clinical Safety Data Management:
1. Single Cases of Serious, Unexpected ADRs (SUSAR)

All adverse drug reactions (ADRs) that are both serious and unexpected are subject to expedited reporting. This applies to reports from spontaneous sources and from any type of clinical or epidemiological investigation, independent of design or purpose.

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.

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