PROTOCOLREFERENCE OUTLINE

Veterinary Clinical Study Protocol

Study protocol under veterinary good clinical practice, where the subject cannot consent and the owner or producer can: target species and husbandry matched to intended use, written owner consent covering withdrawal obligations, animal welfare and ethical review, evidenced food-chain protection rather than a withdrawal period merely stated, and safety recording that includes humans exposed during handling. Maps to VICH GL9.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
VICH GL9
DOCUMENT TYPE
Protocol
LAST UPDATED
August 2026
PURPOSE

Veterinary good clinical practice governs studies of veterinary products in the species the product is intended for. It is distinct for structural reasons: the subject cannot consent, the owner or producer can, and food-producing animals put the human food chain in scope. Carrying assumptions across from human trial documents is the common failure, because consent, welfare review and food-chain obligations are all differently scoped.

What's Inside

✓Study identification stating the standard applied, so no reader assumes a human trial framework by default
✓Target species, class and husbandry conditions matched to the intended conditions of use
✓Owner or producer written informed consent, covering withdrawal obligations and what they must do
✓Animal welfare arrangements, ethical review, and the humane endpoints that stop an animal’s participation
✓Food-chain protection controls with an evidence column against each, not a withdrawal period merely stated
✓Investigator and sponsor responsibilities, including who may treat and who records what was given
✓Safety recording covering the treated animals and the humans exposed during handling or administration

How to Use It

1State the standard applied in the identification section, so nobody reads the document against a human trial framework by default.
2Do not carry human trial assumptions across — consent, welfare review and food-chain obligations are all differently scoped here.
3Run the study in the intended species under husbandry like the intended use; convenience produces data that do not transfer to the label sought.
4Evidence the withdrawal period rather than merely stating it, because without evidence there is no proof treated product stayed out of the food chain.
5Define humane endpoints before the study starts, so the decision to stop is not taken under pressure by someone invested in the result.
6Record adverse events in humans exposed during handling or administration; omitting them leaves a whole exposed population unobserved.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Study Identification and Standard Applied
2Target Species and Conditions of Use
3Owner or Producer Informed Consent
4Animal Welfare and Ethical Review
5Food-Chain Protection
6Responsibilities and Safety Recording
REGULATORY CONTEXT

VICH GL9 is the harmonised good clinical practice guideline for veterinary clinical studies, covering investigator and sponsor responsibilities, owner or producer consent, animal welfare, study conduct and record keeping. It is a different standard from ICH E6 and should not be read as a veterinary edition of it. It does not set your species, husbandry, humane endpoints or withdrawal evidence — those are the sponsor’s scientific determinations. Guidance notes here are SPEQ practitioner synthesis.

MAPPED STANDARDS
VICH GL9
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