Chicken Soup for the Busy Coordinator September 2009

What Is An UPIRTSO? UPIRTSO refers to Unanticipated Problem Involving Risks to Subjects or Others. It is any incident, experience, or outcome that meets all of the following criteria: 1.Unexpected, i.e. nature, severity, or frequency is not consistent with (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; or (b) the characteristics of the subject population being studied; 2.Related or possibly related to a subjects participation in the research; and 3.Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) related to the research than was previously known or recognized. Feed Of The Month

Case Study Scenario: A subject enrolled in a multicenter clinical trial receives a dose of an experimental agent that is 10- times higher than the dose dictated by the approved protocol. The subject experienced no detectable harm or adverse effect after an appropriate period of careful observation. Is this event an UPIRTSO?

Answer: Yes. This is an event of UPIRTSO. The incident is [1] Unexpected, [2] Related to participation in the research and [3] It placed subject at a greater risk of physical harm than was previously known or recognized.

References: DSRB SOP 201-E02 Click here PCR SOP 501-C05 Click here Office for Human Research Protection (OHRP) – Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events Click here

Contributed By Ms Judy Tay Ag Manager Research Quality Assurance Research & Development Office National Healthcare Group

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