It is requested that effectiveness and target animal safety study protocols follow this suggested format. This format may also be used to prepare the final reports by clinical investigators, study monitors, and the sponsor. More uniform reports should facilitate a systematic, orderly review of the data. This will enhance the efficiency of each CVM reviewer resulting in quicker more complete review of the data. Guidelines state procedures or practices that may be useful to the persons to whom they are directed, but are not legal requirements.
Guidelines represent the agency's position on a procedure or practice at the time of their issuance.
A person may follow the guideline or may choose to follow alternative procedures. The guideline does not bind the agency, and it does not create of confer any rights, privileges, immunities, or benefits for or on any person. Where the guideline states a requirements imposed by statute or regulation, however, the requirement is law and its force and effect are not changed in any way by virtue of its inclusion in the guideline. This guideline was written in response to a need perceived by the Center for Veterinary Medicine in its work with the animal health industry. 8.5.1 Extent of blinding, e.g., monitor, investigator, etc.