UNANTICIPATED PROBLEMSDEFINITIONS AND REPORTING GUIDELINES FOR THE HSR UNANTICIPATED

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I would like to share a few comments with you all regarding the information discussed in the FDA Conference call on adverse events and unanticipated problems that was held today

Unanticipated Problems-Definitions and Reporting Guidelines for the HSR

Unanticipated problem:

An unanticipated problem is any event, experience, issue, instance, problem, or outcome that meets all 3 of the following criteria:

ALL Unanticipated Problems must be reported to the IRB-HSR.

The unanticipated problem may be reported as an Unanticipated Problem, an Adverse Event, a Protocol Violation or Enrollment Exception depending on the circumstances of the problem.

If the Unanticipated Problem is also an Adverse Event (e.g.: meets all three criteria below) submit the report using the Adverse Event Reporting program in IRB Online (www.irb.virginia.edu)


If the Unanticipated Problem is also the result of a Protocol Violation, submit as a Protocol Violation.


If the Unanticipated Problem is NOT an Adverse Event or the result of a Protocol Violation, submit as an Unanticipated Problem. Here are some examples of items that might fit the category of an Unanticipated Problem:












02/08/08


UNANTICIPATED PROBLEMSDEFINITIONS AND REPORTING GUIDELINES FOR THE HSR UNANTICIPATED
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