FDA to Hold Public Workshop on Clinical Trial Requirements

The FDA is holding a two-day workshop in April to discuss statutory and regulatory requirements for clinical trials.

Scheduled for April 13-14 in Philadelphia, the workshop will include industry and FDA perspectives on proper conduct of clinical trials regulated by the agency. The workshop is targeted to sponsors, monitors, clinical investigators, institutional review boards and any persons who interact with those parties.

Specific topics of discussion will include:

The FDA and confidence in the conduct of clinical research;

Drug, medical device and biological product aspects of clinical research;

Investigator-initiated research;

Ethics in subject enrollment;

Electronic records requirements;

Informed consent requirements;

Adverse event reporting; and

FDA inspections of bioresearch facilities.

For more information, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/ora054.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/ora054.pdf).