Inspections, Compliance, Enforcement, and Criminal Investigations

Compliance Program 7348.810 BIORESEARCH MONITORING

SPONSORS, CONTRACT RESEARCH ORGANIZATIONS AND MONITORS
Date of Issuance: March 11, 2011
Guidance for FDA Staff

This document is intended to provide guidance. It represents the Agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

Page Last Updated: 04/15/2015
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