[Assessment of SUSARs. Clinical evaluation of single cases in terms of regulatory requirements].
In the course of implementing the European directives on pharmaceutical law, focus is set on suspected unexpected serious adverse reactions (SUSARs). SUSARs are essential for expedited reporting to authorities and ethics committees. During on-line monitoring of the study, the investigator documents all adverse events. Serious adverse events are forwarded to the sponsor in due time. The sponsor identifies SUSARs for expedited reporting. Clinical causality assessment between the investigational product and the adverse event is substantial in this process. This requires a balanced clinical assessment of all case relevant aspects and information available reflecting the complexity of the specific case, which cannot be covered by algorithms in general. In the setting of on-line monitoring, SUSARs ensure the safety of the patient and the study. In addition, SUSARs are relevant for generation of the safety profile of the substance.
Wroblewski
H
H
Bayer Vital, Leverkusen. henryk.wroblewski@bayerhealthcare.com
Schmickler
M
M
D000465:Algorithms; D026661:Clinical Trials Data Monitoring Committees / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D016494:Computer Security / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005858:Germany; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D016347:Medical Records Systems, Computerized / Q000331:legislation & jurisprudence; D012109:Research Support as Topic / Q000331:legislation & jurisprudence