Workshop to Focus on Clinical Trial Requirements

The FDA's Chicago district office and the Society of Clinical Research Associates are sponsoring a workshop on FDA clinical trial statutory and regulatory requirements May 16-17 in Oak Brook, Ill.

The workshop targets sponsors, monitors, clinical investigators, institutional review boards and others involved in clinical research. Sessions will offer both industry and FDA perspectives on the proper conduct of clinical trials regulated by the FDA.

Topics for discussion include:FDA regulation of the conduct of clinical research; Medical device, drug and biologic aspects of clinical research; Investigator-initiated research; Pre-investigational new drug application meetings and the FDA meeting process; Informed consent requirements; The ethics of subject enrollment; FDA regulation of institutional review boards; Electronic records requirements; Adverse event reporting; How the FDA conducts bioresearch inspections; and What happens after an FDA inspection.

The meeting notice can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/ora075.pdf ( http://www.fda.gov/OHRMS/DOCKETS/98fr/ora075.pdf ).