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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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.
  Cover Page
Part I Background
Part II Implementation
Part III Inspectional
Part IV Analytical
Part V Regulatory/Administrative
Part VI References and Program Contact
Part VII Headquarters' Responsibilities
CP 7348.810  as an Adobe Acrobat (.pdf) file