Suspected Unexpected Serious Adverse Reaction

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As Suspected Unexpected Serious Adverse Reaction (SUSAR) or as a suspected case of unexpected serious adverse effect is called an adverse event in a clinical trial , the unexpected and is severe and at the same time probably (in a causal causal ) connection with an investigational is and thus a side effect could represent.

The acronym "SUSAR" has in German speaking countries since its launch with the EU - Directive 2001/20 / EC for "good clinical practice" becomes independent (GCP Directive) as the word and will thus also be used in German texts.

SUSAR is a term used in drug research and refers to possible side effects of preparations in clinical trials and not to the side effects of drugs that have already been approved.

Minimum criteria

There must be a serious adverse event. According to the GCP regulation and the German Medicines Act, all adverse events are considered serious, the

  • result in the death of a subject ,
  • are immediately life-threatening,
  • necessitate an unforeseen hospital stay or the extension of a hospital stay,
  • result in a congenital abnormality or a birth defect, or
  • result in permanent or serious disability or disability.

In addition, there must be a causal relationship between the administration of the test product and the event.

Furthermore, it must be ruled out that the type and severity of the event are contained in the information already known about the investigational medicinal product. This information can be found, for example, in the examiner's brochure , the technical information or the test plan .

If the investigator or sponsor believes all three criteria are met, it is a SUSAR.

Reporting deadlines

Reports must be made immediately after a serious adverse event has been classified as SUSAR (i.e. after the minimum criteria have been met), at the latest within 15 calendar days. Deaths or life-threatening reactions have a shorter reporting period of 7 days. Additional relevant data must be submitted within a further 8 calendar days at the latest.

report

In principle, those subject to the duty to report from SUSARs should meet the requirements of the ICH guideline E2B (M) on electronic reporting extended by ICH guideline E2B (R3).

In exceptional cases, the CIOMS notification form is recommended. The EudraCT number should always be given. The BfArM expected in addition, if possible, the BfArM template number.

See also

Web links

Individual evidence

  1. ↑ Institute for Medical Informatics, Statistics and Epidemiology Drug Safety at imise ( Memento from March 20, 2008 in the Internet Archive )
  2. ↑ For the definition of an investigational product, see Section 3, Paragraph 3 of the Ordinance on the Application of Good Clinical Practice when Conducting Clinical Trials with Medicinal Products for Use in Humans (GCP Ordinance) (PDF; 84 kB)
  3. ^ Paul Ehrlich Institute Side Effects in Clinical Trials
  4. ↑ Federal Institute for Drugs and Medical Devices reporting requirements for the implementation of a clinical trial
  5. ↑ Federal Institute for Drugs and Medical Devices What reporting obligations exist for SUSAR reports to ethics committees and examiners?
  6. ↑ ICH Topic E2BM Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (English; PDF; 117 kB)
  7. ↑ ICH Topic E 2 B (R3) Data Elements for Transmission of Individual Case Safety Reports (English; PDF; 2.1 MB)
  8. ↑ CIOMS Form I ( Memento from July 6, 2011 in the Internet Archive )