Issue Date: July 10, 2001
Issued by: Center for Veterinary Medicine
Topic(s): Environmental Safety, Target Animal – Effectiveness, Target Animal – Safety
Status: Final
CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials
The purpose of this document is to suggest a uniform system for writing study protocols and to provide a list of essential items that should be included in a study protocol. Guidance #85 entitled “Good Clinical Practices” became final on May 15, 2001. Until the Center revises guidance #56, sponsors should follow the recommendations in guidance #85 when differences among the guidances occur.
Download the Guidance Document
