SPONSORS, CONTRACT RESEARCH ORGANIZATIONS AND MONITORS
Date of Issuance: April 19, 2017
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.