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Unanticipated Problem and or Adverse Event - Purdue University - purdue

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The document outlines the procedures for reporting unanticipated problems and adverse events in research studies at Purdue University. It specifies that such events must be reported to the Institutional Review Board (IRB) within 48 hours, with a detailed written report due within 5 business days. The form includes sections for protocol information, nature of the problem/event, actions taken, and follow-up measures. It emphasizes compliance with both IRB and any additional reporting requirements from sponsors or regulatory bodies.

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What qualifies as an adverse event?

Adverse Event - An event in which care resulted in an undesirable clinical outcome-an outcome not caused by underlying disease-that prolonged the patient stay, caused permanent patient harm, required life-saving intervention, or contributed to death.

Is an adverse event expected or unexpected?

An adverse event is any undesirable and unintended, although not necessarily unexpected, effect of the research occurring in human subjects as a result of (a) the interventions and interactions used in the research; or (b) the collection of identifiable private information under the research (Adapted from the 1993

What is an unanticipated problem in FDA?

Definition: Unanticipated Problems are considered to include any incident, experience, or outcome that meets all of the following criteria: Unexpected (in terms of nature, severity, or frequency) given (a) the. research procedures that are described in the protocol-related.

Are all adverse effects unexpected?

Adverse Events The event can either be a type A reaction or a type B reaction. Type A reactions are predictable adverse events which are commonly dose dependent and can be mild, moderate, or severe. Type B reactions are completely unpredictable and have nothing to do with doses.

Is an adverse event always an unanticipated problem?

An adverse event may be anticipated and thus listed in the risks section of your protocol. If it is not included in the risk section of your protocol, it would be considered unanticipated. Unanticipated Problems should meet the following three criteria: Must be unexpected in terms of nature, severity or frequency.

Are all adverse events are unexpected?

The vast majority of adverse events occurring in human subjects are not unanticipated problems. A small proportion of adverse events are unanticipated problems. Unanticipated problems include other incidents, experiences, and outcomes that are not adverse events.

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