J Korean Soc Clin Pharmacol Ther.  2011 Dec;19(2):98-108.

A Study on Management and Report of Adverse Event in Clinical Trials

• Lee S
• Kim YI
• Yim H
• Lee G
• Choe B

Abstract

BACKGROUND
This research is to identify the difficulties occuring in the course of managing the adverse events and the adverse event related standard operating procedure in the regulation of each institutional review board.
METHODS
In order to identify the issues of the management of adverse events of each institution, this research surveyed the IRB administrators in fifty two university hospitals nation-wide. This survey is conducted among one chairman and one IRB member from the IRB members per each IRB who have experience in reviewing adverse events. The survey also includes investigators and sponsors who engage in reporting adverse events.
RESULTS
The result of this survey demonstrates that the objects and the terms of adverse event reports provided by the Standard Operating Procedure and the KGCP of each institution are not very different from each other. However, according to the survey, any cases reported to the IRBs, although they are not specified as the object of reports in the institution, have been reviewed by the IRB members. To sum up the results of the survey, the major issues include ambiguous regulations on adverse event reports and reviews, the use of different report formats for each institution, and the difficulty with evaluating the causal relationship with Investigational Product.
CONCLUSION
It is necessary to develop concrete and specified guidelines on the objects and the terms of reports, the standard for the causal relationship and the adequate measures for adverse events after review and to standardize the format of adverse event reporting.

Keyword

Adverse event (AE); Suspected unexpected serious adverse reaction (SUSAR); Review and reporting of adverse event; Institutional review board (IRB)

MeSH Terms

Administrative Personnel
Ethics Committees, Research
Hospitals, University
Humans
Research Personnel
Social Control, Formal