FDA HOLDING CLINICAL TRIALS WORKSHOP NEXT YEAR

The FDA's Los Angeles District is holding a workshop on the agency's statutory and regulatory requirements for clinical trials Feb. 78 in San Diego.

The two-day workshop, cosponsored by the Society of Clinical Research Associates, is aimed at sponsors, monitors, clinical investigators, institutional review boards (IRBs) and others concerned with FDA-regulated clinical research.

The workshop will cover both industry and FDA perspectives on the proper conduct of FDA-regulated clinical trials. Topics to be discussed include:

FDA regulation of clinical research;

Medical device, drug, biologic product and food 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 IRBs;

Electronic records requirements;

Adverse event reporting;

How the FDA conducts bioresearch inspections; and

What happens after an FDA inspection.

The notice of the workshop can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/ora0619-nm00001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/ora0619-nm00001.pdf).